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CompletedNCT02312687Updated May 6, 2024Results posted

Long-Term Extension Study of KRN23 in Adult Subjects With X-Linked Hypophosphatemia (XLH)

A Phase 2 interventional study of KRN23 in X-Linked Hypophosphatemia, sponsored by Kyowa Kirin, Inc.. Completed at 5 sites in United States. Per ClinicalTrials.gov, last updated 2024-05-06.

Sponsored by Kyowa Kirin, Inc. · Phase 2, Interventional, and Treatment

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Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 18 studies testing burosumab in Familial Hypophosphatemic Rickets — none open to participants now, none under way, none of them phase 3. burosumab · Familial Hypophosphatemic Rickets.

Enrollment
11th of 18
20 · median 26
Started
2015
with 2 others
Phase 2
3 of 18
none open now
Registered
6th of 18
by date
Lead sponsor
6 of 18
Kyowa Kirin, Inc.

Among the 18 studies testing burosumab in Familial Hypophosphatemic Rickets, this one is the 11th largest by enrollment, is one of 3 that started in 2015, is one of 3 in phase 2, and was the 6th registered.

Familial Hypophosphatemic Rickets

49 studies on the registry are indexed under Familial Hypophosphatemic Rickets; 8 are open to participants now.

Browse Familial Hypophosphatemic Rickets studies →

Open to participants now

None of the 18 studies testing burosumab in Familial Hypophosphatemic Rickets is open now. The open studies under Familial Hypophosphatemic Rickets, anywhere →

About burosumab

burosumab: first FDA approval 2018 (CRYSVITA), first EMA approval 2018. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 4 Familial Hypophosphatemic Rickets studies recruiting now, 2 set no upper age limit and 2 stop at 75 or younger; 3 take children under 18; 1 takes healthy volunteers.

This study: all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Download CSVNarrow it in search →With an account: the 18 studies testing burosumab in Familial Hypophosphatemic Rickets as a file.
02

Study summary

The primary objectives of this study are to:

  • Assess the long-term safety of KRN23 subcutaneous (SC) administration in adult subjects with XLH
  • Assess the proportion of subjects achieving serum phosphorus levels in the normal range (2.5-4.5 mg/dL) with long-term administration of KRN23
  • Assess long-term pharmacodynamics (PD) of KRN23 as measured by changes in the following: serum intact parathyroid hormone (iPTH); serum and urinary phosphorus; ratio of renal tubular maximum phosphate reabsorption rate to glomerular filtration rate (TmP/GFR) and tubular reabsorption of phosphate (TRP); serum 1,25-dihydroxy vitamin D (1,25[OH]2D); serum fibroblast growth factor 23 (FGF23); bone biomarkers: serum alkaline phosphatase (ALP), bone-specific ALP (BALP), carboxy terminal crosslinked telopeptide of type I collagen (CTx), and procollagen type 1 N-terminal propeptide (P1NP)
  • Assess long-term immunogenicity of KRN23 as measured by presence of anti-KRN23 antibody (ADA)
03

Conditions studied

  • X-Linked Hypophosphatemia

Keywords

  • XLH
  • FGF23
  • KRN23
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Have participated in Kyowa Hakko Kirin Pharma, Inc.'s KRN23-INT-001 (NCT01340482) or KRN23-INT-002 (NCT01571596) studies (received at least 2 doses of KRN23)
  2. Estimated (eGFR) ≥ 60 mL/min or eGFR of 45 to \< 60 mL/min at Screening with confirmation that the renal insufficiency was not due to nephrocalcinosis.
  3. Sexually active subjects must be willing to use an acceptable method of (e.g., double barrier method) while participating in the study and for 30 days after receiving the last dose of KRN23.

Exclusion criteria

Exclusion Criteria:

  1. Subject experienced a safety-related event in the KRN23-INT-001 or KRN23-INT-002 study that, in the opinion of the investigator and sponsor, precludes resuming KRN23 treatment.
  2. Presence of nephrocalcinosis on renal ultrasound that, in the opinion of the investigator and sponsor, precludes resuming KRN23 treatment.
  3. Pregnant or breastfeeding at Screening or planning to become pregnant (self or partner) at any time during the study.
  4. Participation in an drug or device trial within 30 days of enrollment (other than KRN23-INT-001 or KRN23-INT-002).
  5. Use of a pharmacologic vitamin D metabolite or analog (e.g., calcitriol, doxercalciferol, and paricalcitol), phosphate, or aluminum hydroxide antacids (e.g., Maalox® and Mylanta®) within 21 days prior to Screening or during the study.
  6. Use of medication to suppress parathyroid hormone (PTH) (e.g., Sensipar®, cinacalcet, calcimimetics) within 2 months prior to Screening.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    KRN23

    KRN23 subcutaneous (SC) injections every 4 weeks. Starting doses will be based on the subject's last dose in study KRN23-INT-001 (NCT02312687) or KRN23-INT-002 (NCT01571596). Doses may be titrated to achieve the target peak serum phosphorus range.

    Biological: KRN23

Interventions

  • BiologicalKRN23

    solution for SC injection

    Also known as: burosumab, Crysvita®

06

What researchers measure

Primary outcomes

  1. Number of Participants With Adverse Events (AEs), Treatment Emergent AEs (TEAEs), Serious AEs (SAEs), and AEs Leading to Discontinuation or Death

    An AE is defined as any untoward medical occurrence, whether or not considered drug related. An SAE or serious suspected adverse reaction is an AE or suspected adverse reaction that at any dose, in the view of either the investigator or sponsor, results in any of the following outcomes: death; a life-threatening AE; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; a congenital anomaly/birth defect; an important medical event. A TEAE is an AE that occurred on or after the first burosumab dose. AEs were graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). AEs were classified by the Investigator as possibly related, probably related, or definitely related.

    Time frame: Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).

  2. Number of Participants With Clinically Significant Changes From Baseline in Vital Signs

    Clinically significant changes from baseline reported as adverse events are presented.

    Time frame: Through Week 184

  3. Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, by Category

    Clinically significant changes from baseline reported as adverse events are presented.

    Time frame: Through Week 184

  4. Number of Participants With Clinically Significant Changes From Baseline in Physical Exams, by Category

    Clinically significant changes from baseline reported as adverse events are presented.

    Time frame: Through Week 184

  5. Number of Participants With Clinically Significant Changes From Baseline in Echocardiogram (ECHO) Tests

    Clinically significant changes from baseline reported as adverse events are presented.

    Time frame: Through Week 184

  6. Number of Participants With Clinically Significant Changes From Baseline in ECGs

    Clinically significant changes from baseline reported as adverse events are presented.

    Time frame: Through Week 184

  7. Number of Participants With Clinically Significant Changes From Baseline in Renal Ultrasound, by Category

    Clinically significant changes from baseline reported as adverse events are presented.

    Time frame: Through Week 184

  8. Number of Participants Positive for Anti-KRN23 Antibodies and Neutralizing Antibodies at Baseline and Anytime Post-Baseline

    Time frame: Through Week 184

  9. Percentage of Participants Reaching Serum Phosphorus Normal Range at Baseline and Any Time After Dosing

    Time frame: Through Week 184

  10. Change From Baseline Over Time in Serum Phosphorus

    Time frame: Baseline, Weeks 24, 48, 72, 96, 120, 144

  11. Change From Baseline Over Time in Serum iPTH

    Time frame: Baseline, Weeks 24, 48, 72, 96, 120, 144

  12. Change From Baseline Over Time in Serum Total FGF23

    Time frame: Baseline, Weeks 24, 48, 72, 96, 120, 144

  13. Change From Baseline Over Time in Serum Free FGF23

    Time frame: Baseline, Weeks 24, 48, 72, 96, 120, 144

  14. Change From Baseline Over Time in Serum 1,25(OH)2D

    Time frame: Baseline, Weeks 24, 48, 72, 96, 120, 144

  15. Change From Baseline Ovr Time in 2-hour Urine TmP/GFR

    Time frame: Baseline, Weeks 24, 48, 72, 96, 120, 144

  16. Change From Baseline Over Time in in 2-hour Urine TRP

    Time frame: Baseline, Weeks 24, 48, 72, 96, 120, 144

  17. Change From Baseline Over Time in FEP

    Time frame: Baseline, Weeks 24, 48, 72, 96, 120, 144

  18. Change From Baseline Over Time in 24-hour Urine Phosphorus

    Time frame: Baseline, Weeks 24, 48, 72, 96, 120, 144

  19. Change From Baseline Over Time in 24-Hour Urine Calcium

    Time frame: Baseline, Weeks 24, 48, 72, 96, 120, 144

  20. Change From Baseline Over Time in 24-Hour Urine Creatinine

    Time frame: Baseline, Weeks 24, 48, 72, 96, 120, 144

  21. Change From Baseline Over Time in 24-Hour Urine Calcium/Creatinine Ratio

    Time frame: Baseline, Weeks 24, 48, 72, 96, 120, 144

  22. Change From Baseline Over Time in Total ALP

    Time frame: Baseline, Weeks 24, 48, 72, 96, 120, 144

  23. Change From Baseline Over Time in BALP

    Time frame: Baseline, Weeks 24, 48, 72, 96, 120, 144

  24. Change From Baseline Over Time in CTx

    Time frame: Baseline, Weeks 24, 48, 72, 96, 120, 144

  25. Change From Baseline Over Time in P1NP

    Time frame: Baseline, Weeks 24, 48, 72, 96, 120, 144

07

Results

Posted Dec 16, 2019

Participant flow

Participant flow — Overall Study
MilestoneKRN23
Started20
Completed19
Not completed1
Withdrew: Other, not specified1

Outcome measures

PrimaryNumber of Participants With Adverse Events (AEs), Treatment Emergent AEs (TEAEs), Serious AEs (SAEs), and AEs Leading to Discontinuation or Death

An AE is defined as any untoward medical occurrence, whether or not considered drug related. An SAE or serious suspected adverse reaction is an AE or suspected adverse reaction that at any dose, in the view of either the investigator or sponsor, results in any of the following outcomes: death; a life-threatening AE; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; a congenital anomaly/birth defect; an important medical event. A TEAE is an AE that occurred on or after the first burosumab dose. AEs were graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). AEs were classified by the Investigator as possibly related, probably related, or definitely related.

Time frame:
Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events (AEs), Treatment Emergent AEs (TEAEs), Serious AEs (SAEs), and AEs Leading to Discontinuation or Death
ParticipantsKRN23
All AEs20
TEAEs20
Related AEs12
SAEs9
Related SAEs1
Grade 3 and 4 AEs10
AEs Leading to Discontinuation0
AEs Leading to Death0
PrimaryNumber of Participants With Clinically Significant Changes From Baseline in Vital Signs

Clinically significant changes from baseline reported as adverse events are presented.

Time frame:
Through Week 184
Reported as:
Count of participants · Participants
Number of Participants With Clinically Significant Changes From Baseline in Vital Signs
ParticipantsKRN23
Hypertension2
Decreased blood pressure1
PrimaryNumber of Participants With Clinically Significant Changes From Baseline in Laboratory Values, by Category

Clinically significant changes from baseline reported as adverse events are presented.

Time frame:
Through Week 184
Reported as:
Count of participants · Participants
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, by Category
ParticipantsKRN23
Elevated eosinophils1
Hypercholesterolemia1
Hyperkalemia1
Hyperglycemia1
Elevated alanine aminotransferase1
Elevated aspartate aminotransferase1
Elevated gamma-glutamyl transferase2
Proteinuria2
Elevated amylase2
Elevated alkaline phosphatase1
Elevated lipase1
Hypercalciuria1
Worsening hypercholesterolemia2
Decreased hemoglobin2
Hypocalcemia (intermittent)1
Hypovitaminosis D1
Elevated cholesterol1
Hyperparathyroidism1
Urine electrophoresis abnormal1
PrimaryNumber of Participants With Clinically Significant Changes From Baseline in Physical Exams, by Category

Clinically significant changes from baseline reported as adverse events are presented.

Time frame:
Through Week 184
Reported as:
Count of participants · Participants
Number of Participants With Clinically Significant Changes From Baseline in Physical Exams, by Category
ParticipantsKRN23
Bone pain1
Conjunctival haemorrhage1
Hypoacusis1
Dermal cyst1
Osteoarthritis1
Gravitational oedema1
Hypoaesthesia1
Neuropathy peripheral2
Arthralgia1
Peroneal nerve palsy1
Spinal pain1
Bone lesion1
Femur fracture1
Scrotal oedema1
Synovial cyst1
Testicular swelling1
Thermal burn1
Weight decreased1
PrimaryNumber of Participants With Clinically Significant Changes From Baseline in Echocardiogram (ECHO) Tests

Clinically significant changes from baseline reported as adverse events are presented.

Time frame:
Through Week 184
Reported as:
Count of participants · Participants
Number of Participants With Clinically Significant Changes From Baseline in Echocardiogram (ECHO) Tests
ParticipantsKRN23
Number of Participants With Clinically Significant Changes From Baseline in Echocardiogram (ECHO) Tests0
PrimaryNumber of Participants With Clinically Significant Changes From Baseline in ECGs

Clinically significant changes from baseline reported as adverse events are presented.

Time frame:
Through Week 184
Reported as:
Count of participants · Participants
Number of Participants With Clinically Significant Changes From Baseline in ECGs
ParticipantsKRN23
Number of Participants With Clinically Significant Changes From Baseline in ECGs0
PrimaryNumber of Participants With Clinically Significant Changes From Baseline in Renal Ultrasound, by Category

Clinically significant changes from baseline reported as adverse events are presented.

Time frame:
Through Week 184
Reported as:
Count of participants · Participants
Number of Participants With Clinically Significant Changes From Baseline in Renal Ultrasound, by Category
ParticipantsKRN23
Kidney stone(s)1
Nephrocalcinosis1
Right renal mass1
Nephrolithiasis2
PrimaryNumber of Participants Positive for Anti-KRN23 Antibodies and Neutralizing Antibodies at Baseline and Anytime Post-Baseline
Time frame:
Through Week 184
Reported as:
Count of participants · Participants
Number of Participants Positive for Anti-KRN23 Antibodies and Neutralizing Antibodies at Baseline and Anytime Post-Baseline
ParticipantsKRN23
Baseline: Anti-KRN23 Antibodies2
Post Baseline:Anti-KRN23 Antibodies4
Baseline: Neutralizing Antibodies0
Postbaseline: Neutralizing Antibodies0
PrimaryPercentage of Participants Reaching Serum Phosphorus Normal Range at Baseline and Any Time After Dosing
Time frame:
Through Week 184
Reported as:
Number · percentage of participants
Percentage of Participants Reaching Serum Phosphorus Normal Range at Baseline and Any Time After Dosing
percentage of participantsKRN23
Percentage of Participants Reaching Serum Phosphorus Normal Range at Baseline and Any Time After Dosing100 (83.9 to 100.0)
PrimaryChange From Baseline Over Time in Serum Phosphorus
Time frame:
Baseline, Weeks 24, 48, 72, 96, 120, 144
Reported as:
Least squares mean · mg/dL
Change From Baseline Over Time in Serum Phosphorus
mg/dLKRN23
Change at Week 240.68 ± 0.103
Change at Week 480.68 ± 0.055
Change at Week 720.59 ± 0.077
Change at Week 960.47 ± 0.081
Change at Week 1200.57 ± 0.082
Change at Week 1440.59 ± 0.084
Statistical analysis
  • KRN23 · generalized estimation equation (GEE) · p = < 0.0001 (The generalized estimation equation (GEE) model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Least squares (ls) mean: 0.68 · 95% CI 0.48 to 0.88
  • KRN23 · GEE · p = < 0.0001 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: 0.68 · 95% CI 0.57 to 0.79
  • KRN23 · GEE · p = < 0.0001 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: 0.59 · 95% CI 0.44 to 0.75
  • KRN23 · GEE · p = < 0.0001 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: 0.47 · 95% CI 0.31 to 0.63
  • KRN23 · GEE · p = < 0.0001 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: 0.57 · 95% CI 0.41 to 0.73
  • KRN23 · GEE · p = < 0.0001 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: 0.59 · 95% CI 0.43 to 0.76
PrimaryChange From Baseline Over Time in Serum iPTH
Time frame:
Baseline, Weeks 24, 48, 72, 96, 120, 144
Reported as:
Least squares mean · pg/mL
Change From Baseline Over Time in Serum iPTH
pg/mLKRN23
Change at Week 24-9.75 ± 6.551
Change at Week 48-11.17 ± 7.444
Change at Week 72-18.12 ± 4.567
Change at Week 96-25.28 ± 5.577
Change at Week 120-22.39 ± 4.655
Change at Week 144-28.33 ± 6.007
Statistical analysis
  • KRN23 · GEE estimate · p = 0.1366 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: -9.75 · 95% CI -22.59 to 3.09
  • KRN23 · GEE estimate · p = 0.1334 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: -11.17 · 95% CI -25.76 to 3.42
  • KRN23 · GEE estimate · p = < 0.0001 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: -18.12 · 95% CI -27.07 to -9.17
  • KRN23 · GEE estimate · p = < 0.0001 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: -25.28 · 95% CI -36.21 to -14.35
  • KRN23 · GEE estimate · p = < 0.0001 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: -22.39 · 95% CI -31.51 to -13.26
  • KRN23 · GEE estimate · p = < 0.0001 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: -28.33 · 95% CI -40.11 to -16.56
PrimaryChange From Baseline Over Time in Serum Total FGF23
Time frame:
Baseline, Weeks 24, 48, 72, 96, 120, 144
Reported as:
Mean · pg/mL
Change From Baseline Over Time in Serum Total FGF23
pg/mLKRN23
Change at Week 24215493.38 ± 10634.172
Change at Week 48202525.38 ± 17429.124
Change at Week 72221481.03 ± 21353.941
Change at Week 96221674.07 ± 20592.592
Change at Week 120208270.02 ± 20945.303
Change at Week 144235953.55 ± 35634.821
Statistical analysis
  • KRN23 · GEE · p = < 0.0001 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: 215493.38 · 95% CI 194650.78 to 236335.97
  • KRN23 · GEE · p = < 0.0001 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: 202525.38 · 95% CI 168364.92 to 236685.83
  • KRN23 · GEE · p = < 0.0001 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: 221481.03 · 95% CI 179628.07 to 263333.98
  • KRN23 · GEE · p = < 0.0001 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: 221674.07 · 95% CI 181313.34 to 262034.81
  • KRN23 · GEE · p = < 0.0001 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: 208270.02 · 95% CI 167217.98 to 249322.06
  • KRN23 · GEE · p = < 0.0001 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: 235953.55 · 95% CI 166110.59 to 305796.52
PrimaryChange From Baseline Over Time in Serum Free FGF23
Time frame:
Baseline, Weeks 24, 48, 72, 96, 120, 144
Reported as:
Least squares mean · pg/mL
Change From Baseline Over Time in Serum Free FGF23
pg/mLKRN23
Change at Week 241277.84 ± 38.521
Change at Week 481244.99 ± 40.250
Change at Week 721298.49 ± 33.129
Change at Week 961311.05 ± 37.119
Change at Week 1201368.68 ± 21.063
Change at Week 1441298.41 ± 45.972
Statistical analysis
  • KRN23 · GEE · p = < 0.0001 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: 1277.84 · 95% CI 1202.34 to 1353.34
  • KRN23 · GEE · p = < 0.0001 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: 1244.99 · 95% CI 1166.10 to 1323.88
  • KRN23 · GEE · p = < 0.0001 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: 1298.49 · 95% CI 1233.56 to 1363.43
  • KRN23 · GEE · p = < 0.0001 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: 1311.05 · 95% CI 1238.30 to 1383.80
  • KRN23 · GEE · p = < 0.0001 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: 1368.68 · 95% CI 1327.40 to 1409.96
  • KRN23 · GEE · p = < 0.0001 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: 1298.41 · 95% CI 1208.31 to 1388.51
PrimaryChange From Baseline Over Time in Serum 1,25(OH)2D
Time frame:
Baseline, Weeks 24, 48, 72, 96, 120, 144
Reported as:
Least squares mean · pg/mL
Change From Baseline Over Time in Serum 1,25(OH)2D
pg/mLKRN23
Change at Week 247.87 ± 2.403
Change at Week 482.70 ± 2.653
Change at Week 722.62 ± 2.505
Change at Week 960.31 ± 2.052
Change at Week 120-0.48 ± 2.365
Change at Week 144-3.43 ± 2.844
Statistical analysis
  • KRN23 · GEE · p = 0.0011 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: 7.87 · 95% CI 3.16 to 12.58
  • KRN23 · GEE · p = 0.3092 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: 2.70 · 95% CI -2.50 to 7.90
  • KRN23 · GEE · p = 0.2958 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: 2.62 · 95% CI -2.29 to 7.53
  • KRN23 · GEE · p = 0.8796 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: 0.31 · 95% CI -3.71 to 4.33
  • KRN23 · GEE · p = 0.8396 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: -0.48 · 95% CI -5.11 to 4.16
  • KRN23 · GEE · p = 0.2284 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: -3.43 · 95% CI -9.00 to 2.15
PrimaryChange From Baseline Ovr Time in 2-hour Urine TmP/GFR
Time frame:
Baseline, Weeks 24, 48, 72, 96, 120, 144
Reported as:
Least squares mean · mg/dL
Change From Baseline Ovr Time in 2-hour Urine TmP/GFR
mg/dLKRN23
Change at Week 240.57 ± 0.128
Change at Week 480.47 ± 0.047
Change at Week 720.42 ± 0.072
Change at Week 960.44 ± 0.084
Change at Week 1200.36 ± 0.066
Change at Week 1440.47 ± 0.078
Statistical analysis
  • KRN23 · Ls mean: 0.57 · 95% CI 0.32 to 0.83
  • KRN23 · Ls mean: 0.47 · 95% CI 0.37 to 0.56
  • KRN23 · Ls mean: 0.42 · 95% CI 0.28 to 0.56
  • KRN23 · Ls mean: 0.44 · 95% CI 0.27 to 0.60
  • KRN23 · Ls mean: 0.36 · 95% CI 0.23 to 0.48
  • KRN23 · Ls mean: 0.47 · 95% CI 0.32 to 0.62
PrimaryChange From Baseline Over Time in in 2-hour Urine TRP
Time frame:
Baseline, Weeks 24, 48, 72, 96, 120, 144
Reported as:
Least squares mean · fraction of phosphorus reabsorbed
Change From Baseline Over Time in in 2-hour Urine TRP
fraction of phosphorus reabsorbedKRN23
Change at Week 240.04 ± 0.015
Change at Week 480.01 ± 0.011
Change at Week 720.01 ± 0.011
Change at Week 960.05 ± 0.012
Change at Week 1200.01 ± 0.012
Change at Week 1440.02 ± 0.017
Statistical analysis
  • KRN23 · Ls mean: 0.04 · 95% CI 0.01 to 0.07
  • KRN23 · Ls mean: 0.01 · 95% CI -0.01 to 0.03
  • KRN23 · Ls mean: 0.01 · 95% CI -0.01 to 0.04
  • KRN23 · Ls mean: 0.05 · 95% CI 0.02 to 0.07
  • KRN23 · Ls mean: 0.01 · 95% CI -0.02 to 0.03
  • KRN23 · Ls mean: 0.02 · 95% CI -0.01 to 0.05
PrimaryChange From Baseline Over Time in FEP
Time frame:
Baseline, Weeks 24, 48, 72, 96, 120, 144
Reported as:
Least squares mean · fraction of phosphorus excreted
Change From Baseline Over Time in FEP
fraction of phosphorus excretedKRN23
Change at Week 24-0.04 ± 0.015
Change at Week 48-0.01 ± 0.011
Change at Week 72-0.01 ± 0.011
Change at Week 96-0.05 ± 0.012
Change at Week 120-0.01 ± 0.012
Change at Week 144-0.02 ± 0.017
Statistical analysis
  • KRN23 · Ls mean: -0.04 · 95% CI -0.07 to -0.01
  • KRN23 · Ls mean: -0.01 · 95% CI -0.03 to 0.01
  • KRN23 · Ls mean: -0.01 · 95% CI -0.04 to 0.01
  • KRN23 · Ls mean: -0.05 · 95% CI -0.07 to -0.02
  • KRN23 · Ls mean: -0.01 · 95% CI -0.03 to 0.02
  • KRN23 · Ls mean: -0.02 · 95% CI -0.05 to 0.01
PrimaryChange From Baseline Over Time in 24-hour Urine Phosphorus
Time frame:
Baseline, Weeks 24, 48, 72, 96, 120, 144
Reported as:
Least squares mean · g/24hr
Change From Baseline Over Time in 24-hour Urine Phosphorus
g/24hrKRN23
Change at Week 24-0.01 ± 0.045
Change at Week 480.02 ± 0.044
Change at Week 720.08 ± 0.044
Change at Week 96-0.01 ± 0.040
Change at Week 120-0.01 ± 0.058
Change at Week 144-0.05 ± 0.054
Statistical analysis
  • KRN23 · Ls mean: -0.01 · 95% CI -0.10 to 0.08
  • KRN23 · Ls mean: 0.02 · 95% CI -0.07 to 0.10
  • KRN23 · Ls mean: 0.08 · 95% CI -0.01 to 0.16
  • KRN23 · Ls mean: -0.01 · 95% CI -0.09 to 0.06
  • KRN23 · Ls mean: -0.01 · 95% CI -0.12 to 0.10
  • KRN23 · Ls mean: -0.05 · 95% CI -0.16 to 0.06
PrimaryChange From Baseline Over Time in 24-Hour Urine Calcium
Time frame:
Baseline, Weeks 24, 48, 72, 96, 120, 144
Reported as:
Least squares mean · mg/24hr
Change From Baseline Over Time in 24-Hour Urine Calcium
mg/24hrKRN23
Change at Week 2422.89 ± 12.605
Change at Week 4815.15 ± 8.914
Change at Week 7211.10 ± 12.975
Change at Week 96-16.65 ± 10.637
Change at Week 1203.48 ± 18.375
Change at Week 14428.55 ± 20.239
Statistical analysis
  • KRN23 · Ls mean: 22.89 · 95% CI -1.81 to 47.60
  • KRN23 · Ls mean: 15.15 · 95% CI -2.32 to 32.62
  • KRN23 · Ls mean: 11.10 · 95% CI -14.33 to 36.53
  • KRN23 · Ls mean: -16.65 · 95% CI -37.50 to 4.20
  • KRN23 · Ls mean: 3.48 · 95% CI -32.53 to 39.49
  • KRN23 · Ls mean: 28.55 · 95% CI -11.12 to 68.22
PrimaryChange From Baseline Over Time in 24-Hour Urine Creatinine
Time frame:
Baseline, Weeks 24, 48, 72, 96, 120, 144
Reported as:
Least squares mean · mg/24hr
Change From Baseline Over Time in 24-Hour Urine Creatinine
mg/24hrKRN23
Change at Week 24-14.77 ± 37.170
Change at Week 48-70.79 ± 46.186
Change at Week 72-16.11 ± 48.389
Change at Week 96-41.74 ± 55.546
Change at Week 120-76.11 ± 82.239
Change at Week 144-96.06 ± 56.389
Statistical analysis
  • KRN23 · Ls mean: -14.77 · 95% CI -87.62 to 58.08
  • KRN23 · Ls mean: -70.79 · 95% CI -161.31 to 19.74
  • KRN23 · Ls mean: -16.11 · 95% CI -110.96 to 78.73
  • KRN23 · Ls mean: -41.74 · 95% CI -150.61 to 67.13
  • KRN23 · Ls mean: -76.11 · 95% CI -237.29 to 85.08
  • KRN23 · Ls mean: -96.06 · 95% CI -206.59 to 14.46
PrimaryChange From Baseline Over Time in 24-Hour Urine Calcium/Creatinine Ratio
Time frame:
Baseline, Weeks 24, 48, 72, 96, 120, 144
Reported as:
Least squares mean · mg/mg
Change From Baseline Over Time in 24-Hour Urine Calcium/Creatinine Ratio
mg/mgKRN23
Change at Week 240.01 ± 0.010
Change at Week 480.01 ± 0.011
Change at Week 720.00 ± 0.011
Change at Week 96-0.01 ± 0.013
Change at Week 1200.00 ± 0.013
Change at Week 1440.03 ± 0.023
Statistical analysis
  • KRN23 · Ls mean: 0.01 · 95% CI -0.01 to 0.03
  • KRN23 · Ls mean: 0.01 · 95% CI -0.01 to 0.04
  • KRN23 · Ls mean: 0.00 · 95% CI -0.02 to 0.02
  • KRN23 · Ls mean: -0.01 · 95% CI -0.04 to 0.02
  • KRN23 · Ls mean: 0.00 · 95% CI -0.02 to 0.03
  • KRN23 · Ls mean: 0.03 · 95% CI -0.01 to 0.08
PrimaryChange From Baseline Over Time in Total ALP
Time frame:
Baseline, Weeks 24, 48, 72, 96, 120, 144
Reported as:
Least squares mean · U/L
Change From Baseline Over Time in Total ALP
U/LKRN23
Change at Week 2414.92 ± 6.935
Change at Week 48-1.73 ± 5.752
Change at Week 72-22.28 ± 4.044
Change at Week 96-20.93 ± 3.567
Change at Week 120-18.77 ± 7.228
Change at Week 144-25.72 ± 5.701
Statistical analysis
  • KRN23 · GEE · p = 0.0314 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: 14.92 · 95% CI 1.33 to 28.52
  • KRN23 · GEE · p = 0.7640 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: -1.73 · 95% CI -13.00 to 9.55
  • KRN23 · GEE · p = < 0.0001 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: -22.28 · 95% CI -30.20 to -14.35
  • KRN23 · GEE · p = < 0.0001 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: -20.93 · 95% CI -27.92 to -13.94
  • KRN23 · GEE · p = 0.0094 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: -18.77 · 95% CI -32.93 to -4.60
  • KRN23 · GEE · p = < 0.0001 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: -25.72 · 95% CI -36.89 to -14.54
PrimaryChange From Baseline Over Time in BALP
Time frame:
Baseline, Weeks 24, 48, 72, 96, 120, 144
Reported as:
Least squares mean · mcg/L
Change From Baseline Over Time in BALP
mcg/LKRN23
Change at Week 244.68 ± 3.389
Change at Week 48-2.68 ± 2.247
Change at Week 72-7.45 ± 1.067
Change at Week 96-8.08 ± 0.910
Change at Week 120-10.01 ± 1.561
Change at Week 144-10.89 ± 1.979
Statistical analysis
  • KRN23 · GEE · p = 0.1673 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: 4.68 · 95% CI -1.96 to 11.32
  • KRN23 · GEE · p = 0.2330 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: -2.68 · 95% CI -7.09 to 1.72
  • KRN23 · GEE · p = < 0.0001 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: -7.45 · 95% CI -9.54 to -5.36
  • KRN23 · GEE · p = < 0.0001 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: -8.08 · 95% CI -9.86 to -6.29
  • KRN23 · GEE · p = < 0.0001 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: -10.01 · 95% CI -13.07 to -6.95
  • KRN23 · GEE · p = < 0.0001 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: -10.89 · 95% CI -14.77 to -7.02
PrimaryChange From Baseline Over Time in CTx
Time frame:
Baseline, Weeks 24, 48, 72, 96, 120, 144
Reported as:
Least squares mean · pg/mL
Change From Baseline Over Time in CTx
pg/mLKRN23
Change at Week 24343.38 ± 135.575
Change at Week 4841.45 ± 61.062
Change at Week 72-61.96 ± 63.458
Change at Week 96-68.62 ± 63.152
Change at Week 120-53.41 ± 50.545
Change at Week 144-97.46 ± 55.670
Statistical analysis
  • KRN23 · GEE · p = 0.0113 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: 343.38 · 95% CI 77.66 to 609.11
  • KRN23 · GEE · p = 0.4972 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: 41.45 · 95% CI -78.23 to 161.13
  • KRN23 · GEE · p = 0.3288 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: -61.96 · 95% CI -186.34 to 62.41
  • KRN23 · GEE · p = 0.2772 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: -68.62 · 95% CI -192.39 to 55.16
  • KRN23 · GEE · p = 0.2907 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: -53.41 · 95% CI -152.47 to 45.66
  • KRN23 · GEE · p = 0.0800 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: -97.46 · 95% CI -206.57 to 11.65
PrimaryChange From Baseline Over Time in P1NP
Time frame:
Baseline, Weeks 24, 48, 72, 96, 120, 144
Reported as:
Least squares mean · ng/mL
Change From Baseline Over Time in P1NP
ng/mLKRN23
Change at Week 2472.45 ± 16.962
Change at Week 4844.40 ± 7.175
Change at Week 7228.30 ± 7.684
Change at Week 9627.02 ± 6.739
Change at Week 12013.02 ± 8.359
Change at Week 14443.12 ± 33.717
Statistical analysis
  • KRN23 · GEE · p = < 0.0001 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: 72.45 · 95% CI 39.21 to 105.70
  • KRN23 · GEE · p = < 0.0001 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: 44.40 · 95% CI 30.34 to 58.47
  • KRN23 · GEE · p = 0.0002 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: 28.30 · 95% CI 13.24 to 43.37
  • KRN23 · GEE · p = < 0.0001 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: 27.02 · 95% CI 13.81 to 40.22
  • KRN23 · GEE · p = 0.1195 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: 13.02 · 95% CI -3.37 to 29.40
  • KRN23 · GEE · p = 0.2009 (The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.) · Ls mean: 43.12 · 95% CI -22.96 to 109.20

Adverse events

Collected over Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
KRN230/20 (0%)9/20 (45%)20/20 (100%)
Most frequent serious events
Showing 10 of 12
Most frequent serious events
EventKRN23
Hereditary Non-Polyposis Colorectal Cancer SyndromeCongenital, familial and genetic disorders1/20
Small Intestinal ObstructionGastrointestinal disorders1/20
Cholecystitis AcuteHepatobiliary disorders1/20
Medical Device Site Joint InfectionInfections and infestations1/20
Musculoskeletal Chest PainMusculoskeletal and connective tissue disorders1/20
OsteoarthritisMusculoskeletal and connective tissue disorders1/20
Adenocarcinoma Of ColonNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/20
ChordomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/20
Lung AdenocarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/20
HemianaesthesiaNervous system disorders1/20
Most frequent other events
Showing 10 of 211
Most frequent other events
EventKRN23
ArthralgiaMusculoskeletal and connective tissue disorders12/20
Back PainMusculoskeletal and connective tissue disorders8/20
Pain In ExtremityMusculoskeletal and connective tissue disorders8/20
NasopharyngitisInfections and infestations7/20
NauseaGastrointestinal disorders6/20
FallInjury, poisoning and procedural complications6/20
HeadacheNervous system disorders6/20
VomitingGastrointestinal disorders5/20
Upper Respiratory Tract InfectionInfections and infestations5/20
HypoaesthesiaNervous system disorders5/20

Baseline characteristics

Age, Continuous
Age, Continuous(years)KRN23
Mean49.8 ± 12.87
Sex: Female, Male
Sex: Female, Male(Participants)KRN23
Female14
Male6
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)KRN23
Hispanic or Latino1
Not Hispanic or Latino19
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)KRN23
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American1
White19
More than one race0
Unknown or Not Reported0
Serum Phosphorus
Serum Phosphorus(mg/dL)KRN23
Mean1.89 ± 0.301
Serum Intact Parathyroid Hormone (iPTH)
Serum Intact Parathyroid Hormone (iPTH)(pg/mL)KRN23
Mean110.8 ± 43.70
Serum Total Fibroblast Growth Factor 23 (FGF23)
Serum Total Fibroblast Growth Factor 23 (FGF23)(pg/mL)KRN23
Mean262.9 ± 227.02
Serum Free FGF23
Serum Free FGF23(pg/mL)KRN23
Mean81.9 ± 42.33

12 further baseline measures are reported on the registry.

08

Study locations

5 sites
  • University California San Francisco Hospital
    San Francisco, California 94143, United States
  • Yale University School of Medicine
    New Haven, Connecticut 06510, United States
  • Indiana University Hospital
    Indianapolis, Indiana 46202, United States
  • Duke University
    Durham, North Carolina 27710, United States
  • Houston Methodist Reasearch Institute
    Houston, Texas 77030, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2015 to primary completion in Nov 2018, 46 months.

Results were first posted in Dec 2019, 1 year after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 3, 2014
First posted
Dec 9, 2014
StartActual
Jan 30, 2015
Primary completionActual
Nov 30, 2018
CompletionActual
Nov 30, 2018
Results first posted
Dec 16, 2019
Last update
May 6, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02312687
Lead sponsor
Kyowa Kirin, Inc.
Collaborators
Kyowa Kirin Co., Ltd.
Responsible party
Sponsor
First posted
Dec 9, 2014
Start date
Jan 30, 2015
Primary completion
Nov 30, 2018
Completion
Nov 30, 2018
Results posted
Dec 16, 2019
Last update
May 6, 2024

Study contacts

Medical Director
study director · Ultragenyx Pharmaceutical Inc

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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