ClinicalTrials.gg
CompletedNCT03588884Updated Dec 9, 2022Results posted

Repeated-dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of CTAP101, Immediate-release Calcifediol, High-dose Cholecalciferol, and Paricalcitol Plus Low-dose Cholecalciferol in Patients With Secondary Hyperparathyroidism, Chronic Kidney Disease 3-4 and Vitamin D Insufficiency

A Phase 4 interventional study of Calcifediol Oral Capsule and Calcifediol Oral Product in Secondary Hyperparathyroidism Due to Renal Causes, Vitamin D Insufficiency and CKD Stage 3, sponsored by OPKO Health, Inc.. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-09.

Sponsored by OPKO Health, Inc. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
69
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

An Open-Label, Repeated-Dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of Oral CTAP101 Capsules, Immediate- Release (IR) Calcifediol, High-Dose Cholecalciferol, and Paricalcitol Plus Low-Dose Cholecalciferol in Patients with Secondary Hyperparathyroidism, Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency

02

Conditions studied

  • Secondary Hyperparathyroidism Due to Renal Causes
  • Vitamin D Insufficiency
  • CKD Stage 3
  • CKD Stage 4
03

In context

Lead sponsor

OPKO Health, Inc. is the lead sponsor of 49 studies on the registry; 2 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 7 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
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. Be at least 18 years of age.
  2. Have stage 3 or 4 CKD (estimated glomerular filtration rate [eGFR] of ≥15 to \<60 millilter per minute per 1.73 meter square (mL/min/1.73 m2) using the Modification of Diet in Renal Disease equation).
  3. Be without any disease state or physical condition that might impair evaluation of safety and efficacy or which, in the Investigator's opinion, would interfere with study participation, including:

    1. Serum albumin ≤ 3.0 (grams per deciliter (g/dL);
    2. Serum transaminase (alanine transaminase, glutamic pyruvic transaminase, aspartate aminotransferase or glutamic oxaloacetic transaminase) > 2.5 times the upper limit of normal at screening; and,
    3. Urinary albumin excretion ≤3000 microgram per milligram (μg/mg) creatinine.
  4. Exhibit during the initial screening visit:

    1. Plasma intact parathyroid hormone (iPTH) ≥70 picogram per milliliter (pg/mL) and \<400 pg/mL if receiving calcitriol or other 1α- hydroxylated vitamin D analog (paricalcitol or doxercalciferol); or
    2. Plasma iPTH ≥100 pg/mL and \<500 pg/mL if not receiving calcitriol or other 1α- hydroxylated vitamin D analog; and,
    3. Serum total 25-hydroxyvitamin D \<30 nanogram per milliliter (ng/mL).
  5. If taking calcitriol, other 1α-hydroxylated vitamin D analog, or vitamin D supplementation, must forgo treatment with these non-study agents for the duration of the study and undergo a 4-week washout period.
  6. Exhibit after the 4-week washout period (if required):

    1. Plasma iPTH ≥100 pg/mL and \<500 pg/mL;
    2. Corrected serum calcium \<9.8 mg/dL; (corrected for serum albumin)
    3. Serum total 25-hydroxyvitamin D \<30 nanogram per milliliter (ng/mL); and,
    4. Serum phosphorus \<5.5 milligram per deciliter (mg/dL).
  7. If taking more than 1,500 milligram per day (mg/day) of elemental calcium, reduce calcium use (to approximately 1,000 to ≤1,500 mg/day) for the duration of the study.
  8. Willing and able to comply with study instructions and commit to all clinic visits for the duration of the study.
  9. Female subjects of childbearing potential must be neither pregnant nor lactating and must have negative blood pregnancy tests at the first screening visit.
  10. All female subjects of childbearing potential and male subjects with female partners of childbearing potential must agree to use effective contraception (implants, injectables, combined oral contraceptives, intrauterine device, sexual abstinence, vasectomy or vasectomized partner) for the duration of the study.
  11. Be able to read, understand and sign the subject Informed Consent Form (ICF) or have a legal authorized representative (LAR) sign the ICF.

Exclusion criteria

Exclusion Criteria:

  1. History of or planned kidney transplant or parathyroidectomy
  2. History (prior 3 months) of corrected serum calcium ≥9.8 mg/dL or serum phosphorus ≥5.5 mg/dL if not receiving calcitriol or other 1α-hydroxylated vitamin D analog.
  3. Need for phosphate binders to maintain the serum phosphate \< 5.5 mg/dL or use of phosphate binders within 4 weeks prior to screening
  4. Use of calcimimetic therapy (cinacalcet or etelcalcetide) within 12 weeks of screening.
  5. Receipt of bisphosphonate therapy or other bone modifying treatment within 6 months prior to enrollment.
  6. Known previous or concomitant serious illness or medical condition, such as malignancy, human immunodeficiency virus, significant gastrointestinal or hepatic disease, intestinal malabsorption disorder, hepatitis or cardiovascular event that in the opinion of the Investigator may worsen or reduce life expectancy, and/or interfere with participation in the study.
  7. History of neurological/psychiatric disorder, including psychotic disorder or dementia, or any reason which, in the opinion of the Investigator makes adherence to a treatment or follow-up schedule unlikely.
  8. Known or suspected hypersensitivity to any of the constituents of the study drugs.
  9. Currently participating in, or has participated in, an interventional/investigational study within 30 days prior to study screening.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
69 participants (actual)

Study arms

  • Active comparator
    CTAP101

    CTAP101/Calcifediol Capsules 60 micrograms (mcg) once daily at bedtime, except on Days 1 and 29 when dosing will occur in the morning before breakfast

    Drug: Calcifediol Oral Capsule

  • Experimental
    Immediate-release (IR) calcifediol

    Immediate-release (IR) calcifediol/266 micrograms (mcg) capsule before breakfast on the mornings of Day 1 and Day 29

    Drug: Calcifediol Oral Product

  • Experimental
    Cholecalciferol

    Cholecalciferol/Capsules 300,000 International Units (IU) (high-dose) before breakfast on the mornings of Day 1 and Day 29

    Drug: Cholecalciferol

  • Active comparator
    Paricalcitol

    Paricalcitol/Capsules 1 mcg plus cholecalciferol capsules 800 IU (low-dose) once daily in the morning before breakfast, except on Days 1 and29 when dosing will occur before breakfast

    Drug: Cholecalciferol · Drug: Paricalcitol Oral Capsule

Interventions

06

What researchers measure

Primary outcomes

  1. Incidence and Severity of Treatment-Emergent Adverse Events (TEAE) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

    This study is descriptive and no primary or secondary efficacy endpoints are defined.

    Time frame: 5 months

07

Results

Posted Dec 9, 2022

Participant flow

Participant flow — Overall Study
MilestoneCTAP101Immediate-release (IR) CalcifediolCholecalciferolParicalcitol
Started18181815
Completed18151514
Not completed0331

Outcome measures

PrimaryIncidence and Severity of Treatment-Emergent Adverse Events (TEAE) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

This study is descriptive and no primary or secondary efficacy endpoints are defined.

Time frame:
5 months
Reported as:
Number · number of TEAE count
Incidence and Severity of Treatment-Emergent Adverse Events (TEAE) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
number of TEAE countCTAP101Immediate-release (IR) CalcifediolCholecalciferolParicalcitol
Grade 1 Mild39121310
Grade 2 Moderate1385
Grade 3 Severe2301
Grade Potentially Life Threatening0000
Grade 5 Fatal0000

Adverse events

Collected over 5 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
CTAP1010/18 (0%)1/18 (5.6%)7/18 (38.9%)
Immediate-release (IR) Calcifediol0/18 (0%)2/18 (11.1%)7/18 (38.9%)
Cholecalciferol0/18 (0%)4/18 (22.2%)8/18 (44.4%)
Paricalcitol0/15 (0%)1/15 (6.7%)8/15 (53.3%)
Most frequent serious events
Showing 10 of 13
Most frequent serious events
EventCTAP101Immediate-release (IR) CalcifediolCholecalciferolParicalcitol
Lumbar radiculopathyNervous system disorders0/180/180/181/15
Intervertebral disc protrusionMusculoskeletal and connective tissue disorders0/180/180/181/15
Lumbar spinal stenosisMusculoskeletal and connective tissue disorders0/180/180/181/15
MelaenaGastrointestinal disorders0/181/180/180/15
Rectal haemorrhageGastrointestinal disorders1/180/180/180/15
Hypertensive encephalopathyNervous system disorders0/180/181/180/15
QuadrantanopiaNervous system disorders0/180/181/180/15
Acute respiratory distress syndromeRespiratory, thoracic and mediastinal disorders0/181/180/180/15
Pulmonary oedemaRespiratory, thoracic and mediastinal disorders0/180/181/180/15
CholecystitisHepatobiliary disorders0/180/181/180/15
Most frequent other events
Showing 10 of 57
Most frequent other events
EventCTAP101Immediate-release (IR) CalcifediolCholecalciferolParicalcitol
HeadacheNervous system disorders2/182/180/182/15
DiarrhoeaGastrointestinal disorders2/181/181/181/15
LacerationInjury, poisoning and procedural complications0/180/182/180/15
NauseaGastrointestinal disorders1/180/181/181/15
DyspepsiaGastrointestinal disorders0/180/180/181/15
Lumbar radiculopathyNervous system disorders0/180/180/181/15
EpistaxisRespiratory, thoracic and mediastinal disorders0/180/180/181/15
ArthralgiaMusculoskeletal and connective tissue disorders0/180/181/181/15
Joint swellingMusculoskeletal and connective tissue disorders1/180/180/181/15
Intervertebral disc protrusionMusculoskeletal and connective tissue disorders0/180/180/181/15

Baseline characteristics

Age, Continuous
Age, Continuous(Year)CTAP101Immediate-release (IR) CalcifediolCholecalciferolParicalcitolTotal
Mean67.1 ± 10.770.1 ± 14.467.9 ± 9.863.4 ± 12.067.3 ± 11.8
Sex: Female, Male
Sex: Female, Male(Participants)CTAP101Immediate-release (IR) CalcifediolCholecalciferolParicalcitolTotal
Female11651032
Male71213537
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)CTAP101Immediate-release (IR) CalcifediolCholecalciferolParicalcitolTotal
Hispanic or Latino11114
Not Hispanic or Latino1717171465
Unknown or Not Reported00000
08

Study locations

3 sites
  • National Institute of Clinical Research, Inc.
    Garden Grove, California 92844, United States
  • Research by Design, LLC
    Chicago, Illinois 60643, United States
  • Spaulding Clinical Research
    West Bend, Wisconsin 53095, United States
09

References and documents

Study documents

  • Study protocol · Aug 16, 2019
  • Statistical analysis plan · Dec 19, 2018

Documents are hosted by the registry — open the source record to download them.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2018 to primary completion in Apr 2020, 22 months.

Results were first posted in Dec 2022, 2 years 7 months after primary completion. A results delay was requested in Apr 2021.

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

Registered
Jun 28, 2018
First posted
Jul 17, 2018
StartActual
Jun 8, 2018
Primary completionActual
Apr 24, 2020
CompletionActual
Apr 24, 2020
Results delay requested
Apr 23, 2021
Results first posted
Dec 9, 2022
Last update
Dec 9, 2022
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 Dec 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03588884
Lead sponsor
OPKO Health, Inc.
Responsible party
Sponsor
First posted
Jul 17, 2018
Start date
Jun 8, 2018
Primary completion
Apr 24, 2020
Completion
Apr 24, 2020
Results posted
Dec 9, 2022
Last update
Dec 9, 2022

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Calcifediol · Cholecalciferol

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