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TerminatedNCT04064827Updated Jun 15, 2026Results posted

A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD)

A Phase 3 interventional study of Paricalcitol in Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism (SHPT), sponsored by AbbVie. Terminated at 15 sites in 2 countries. Open to participants aged 0 Years to 9 Years. Per ClinicalTrials.gov, last updated 2026-06-15.

Sponsored by AbbVie · Phase 3, Interventional, and Treatment

Why this study was terminated
Company Decision
Phase
Phase 3
Study type
Interventional
Enrollment
2
Allocation
Not applicable
Ages
0 Years to 9 Years
Sex
All
01

Study summary

The main objective of this study is to evaluate the safety, efficacy and pharmacokinetics of paricalcitol oral solution in pediatric participants of ages 0 to 9 years with SHPT associated with stage 5 CKD receiving Peritoneal Dialysis (PD) or Hemodialysis (HD). The 24-week study is divided into two 12-week dosing periods (Dosing Period 1 followed by Dosing Period 2).

02

Conditions studied

  • Chronic Kidney Disease (CKD)
  • Secondary Hyperparathyroidism (SHPT)

Keywords

  • Chronic Kidney Disease
  • Paricalcitol
  • Hyperparathyroidism
  • Pediatric Subjects
  • Peritoneal Dialysis (PD)
  • Hemodialysis (HD)
  • Intact parathyroid hormone (iPTH)
03

Who can participate

Ages eligible
0 Years to 9 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Participant is currently diagnosed with and/or being treated for secondary hyperparathyroidism (SHPT).
  • Participant must be diagnosed with chronic kidney disease (CKD) stage 5 receiving peritoneal dialysis (PD) or hemodialysis (HD) for at least 30 days prior to initial Screening.
  • For entry into the Washout Period (for vitamin D receptor activator [VDRA] non-naive participants), the participant must meet the appropriate laboratory criteria based upon the participant's age as described in the protocol.
  • For entry into the Dosing Period (for VDRA-naive participants or VDRA non-naive participants who have completed the Washout Period), the participant must meet the appropriate laboratory criteria based upon the participant's age as described in the protocol.

Exclusion criteria

Exclusion Criteria:

  • Participant is scheduled to receive a living donor kidney transplant within 3 months of Screening or is a kidney transplant recipient.
  • Participant is expected to discontinue peritoneal dialysis (PD) or hemodialysis (HD) within 3 months of the initial Screening visit.
  • Participant has had a parathyroidectomy within 12 weeks prior to Screening.
  • Participant is taking maintenance calcitonin, bisphosphonates, glucocorticoids (in a dose equivalent to > 0.16 mg/kg/day or 5 mg prednisone/day, whichever is lower), 4 weeks prior to Dosing.
  • Participant is receiving calcimimetics at the time of Screening or is expected to initiate calcimimetics at any time throughout the study.
  • Participant is unable to take oral medications.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    Participants Receiving Paricalcitol

    Participants will be administered paricalcitol three times a week (TIW) but no more frequently than every other day for 24 weeks

    Drug: Paricalcitol

Interventions

  • DrugParicalcitol

    Paricalcitol oral solution (2.5 mcg/mL) will be administered with an oral dispenser

05

What researchers measure

Primary outcomes

  1. Percentage of Participants Who Achieve Positive Response During Dosing Period 1

    Positive response is defined as having two consecutive \>= 30% reductions from baseline in intact parathyroid hormone (iPTH) or two consecutive iPTH values in the target range between 150 picograms (pg)/milliliters (mL) to 300 pg/mL (16.5-33.0 picomole\[pmol\]/L).

    Time frame: Up to Week 12

  2. Incidence of Hypercalcemia During Dosing Period 1

    Incidence of hypercalcemia is defined as two consecutive, post-baseline, corrected calcium measurements above the normal participants's age-specific upper limit.

    Time frame: Up to Week 12

Secondary outcomes

  1. Percentage of Participants Who Achieve a Positive Response During Dosing Period 2

    Positive response is defined as having two consecutive \>= 30% reductions from baseline in iPTH or two consecutive iPTH values in the target range between 150 pg/mL to 300 pg/mL (16.5-33.0 picomole\[pmol\]/L).

    Time frame: Week 12 through Week 24

  2. Percentage of Participants Who Achieve a Positive Response During Dosing Periods 1 and 2 Combined

    Positive response is defined as having two consecutive \>= 30% reductions from baseline in iPTH or two consecutive iPTH values in the target range between 150 pg/mL to 300 pg/mL (16.5-33.0 picomole\[pmol\]/L).

    Time frame: Up to Week 24

  3. Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Period 1

    Participants who achieve two consecutive \>= 30% reductions in iPTH will be evaluated.

    Time frame: Up to Week 12

  4. Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Period 2

    Participants who achieve two consecutive \>= 30% reductions in iPTH will be evaluated.

    Time frame: Week 12 through Week 24

  5. Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Periods 1 and 2 Combined

    Participants who achieve two consecutive \>= 30% reductions in iPTH will be evaluated.

    Time frame: Up to Week 24

  6. Percentage of Participants Who Achieve Two Consecutive iPTH Values Between 150 pg/mL to 300 pg/mL (16.5 - 33.0 Pmol/L) During Dosing Period 1

    Participants who achieve two consecutive iPTH values between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) will be evaluated.

    Time frame: Up to Week 12

  7. Percentage of Participants Who Achieve Two Consecutive iPTH Values Between 150 pg/mL to 300 pg/mL (16.5 - 33.0 Pmol/L) During Dosing Period 2

    Participants who achieve two consecutive iPTH values between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) will be evaluated.

    Time frame: Week 12 through Week 24

  8. Percentage of Participants Who Achieve Two Consecutive iPTH Values Between 150 pg/mL to 300 pg/mL (16.5 - 33.0 Pmol/L) During Dosing Periods 1 and 2 Combined

    Participants who achieve two consecutive iPTH values between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) will be evaluated.

    Time frame: Up to Week 24

  9. Incidence of Hypercalcemia During Dosing Period 2

    Incidence of hypercalcemia is defined as two consecutive, post-baseline, corrected calcium measurements above the normal participants's age-specific upper limit.

    Time frame: Week 12 through Week 24

  10. Incidence of Hypercalcemia During Dosing Periods 1 and 2 Combined

    Incidence of hypercalcemia is defined as two consecutive, post-baseline, corrected calcium measurements above the normal participants's age-specific upper limit.

    Time frame: Up to Week 24

06

Results

Posted Jun 15, 2026

Participant flow

Participant flow — Overall Study
MilestoneParticipants Receiving Paricalcitol
Started2
Dosing period 12
Dosing period 21
Completed1
Not completed1
Withdrew: Ipth levels too high1

Outcome measures

PrimaryPercentage of Participants Who Achieve Positive Response During Dosing Period 1

Positive response is defined as having two consecutive \>= 30% reductions from baseline in intact parathyroid hormone (iPTH) or two consecutive iPTH values in the target range between 150 picograms (pg)/milliliters (mL) to 300 pg/mL (16.5-33.0 picomole\[pmol\]/L).

Time frame:
Up to Week 12
Reported as:
Number · percentage of participants
Percentage of Participants Who Achieve Positive Response During Dosing Period 1
percentage of participantsParticipants Receiving Paricalcitol
Percentage of Participants Who Achieve Positive Response During Dosing Period 1100
PrimaryIncidence of Hypercalcemia During Dosing Period 1

Incidence of hypercalcemia is defined as two consecutive, post-baseline, corrected calcium measurements above the normal participants's age-specific upper limit.

Time frame:
Up to Week 12
Reported as:
Count of participants · Participants
Incidence of Hypercalcemia During Dosing Period 1
ParticipantsParticipants Receiving Paricalcitol
Incidence of Hypercalcemia During Dosing Period 10
SecondaryPercentage of Participants Who Achieve a Positive Response During Dosing Period 2

Positive response is defined as having two consecutive \>= 30% reductions from baseline in iPTH or two consecutive iPTH values in the target range between 150 pg/mL to 300 pg/mL (16.5-33.0 picomole\[pmol\]/L).

Time frame:
Week 12 through Week 24
Reported as:
Number · percentage of participants
Percentage of Participants Who Achieve a Positive Response During Dosing Period 2
percentage of participantsParticipants Receiving Paricalcitol
Percentage of Participants Who Achieve a Positive Response During Dosing Period 2100
SecondaryPercentage of Participants Who Achieve a Positive Response During Dosing Periods 1 and 2 Combined

Positive response is defined as having two consecutive \>= 30% reductions from baseline in iPTH or two consecutive iPTH values in the target range between 150 pg/mL to 300 pg/mL (16.5-33.0 picomole\[pmol\]/L).

Time frame:
Up to Week 24
Reported as:
Number · percentage of participants
Percentage of Participants Who Achieve a Positive Response During Dosing Periods 1 and 2 Combined
percentage of participantsParticipants Receiving Paricalcitol
Percentage of Participants Who Achieve a Positive Response During Dosing Periods 1 and 2 Combined100
SecondaryPercentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Period 1

Participants who achieve two consecutive \>= 30% reductions in iPTH will be evaluated.

Time frame:
Up to Week 12
Reported as:
Number · percentage of participants
Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Period 1
percentage of participantsParticipants Receiving Paricalcitol
Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Period 1100
SecondaryPercentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Period 2

Participants who achieve two consecutive \>= 30% reductions in iPTH will be evaluated.

Time frame:
Week 12 through Week 24
Reported as:
Number · percentage of participants
Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Period 2
percentage of participantsParticipants Receiving Paricalcitol
Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Period 2100
SecondaryPercentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Periods 1 and 2 Combined

Participants who achieve two consecutive \>= 30% reductions in iPTH will be evaluated.

Time frame:
Up to Week 24
Reported as:
Number · percentage of participants
Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Periods 1 and 2 Combined
percentage of participantsParticipants Receiving Paricalcitol
Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Periods 1 and 2 Combined100
SecondaryPercentage of Participants Who Achieve Two Consecutive iPTH Values Between 150 pg/mL to 300 pg/mL (16.5 - 33.0 Pmol/L) During Dosing Period 1

Participants who achieve two consecutive iPTH values between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) will be evaluated.

Time frame:
Up to Week 12
Reported as:
Number · percentage of participants
Percentage of Participants Who Achieve Two Consecutive iPTH Values Between 150 pg/mL to 300 pg/mL (16.5 - 33.0 Pmol/L) During Dosing Period 1
percentage of participantsParticipants Receiving Paricalcitol
Percentage of Participants Who Achieve Two Consecutive iPTH Values Between 150 pg/mL to 300 pg/mL (16.5 - 33.0 Pmol/L) During Dosing Period 150
SecondaryPercentage of Participants Who Achieve Two Consecutive iPTH Values Between 150 pg/mL to 300 pg/mL (16.5 - 33.0 Pmol/L) During Dosing Period 2

Participants who achieve two consecutive iPTH values between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) will be evaluated.

Time frame:
Week 12 through Week 24
Reported as:
Number · percentage of participants
Percentage of Participants Who Achieve Two Consecutive iPTH Values Between 150 pg/mL to 300 pg/mL (16.5 - 33.0 Pmol/L) During Dosing Period 2
percentage of participantsParticipants Receiving Paricalcitol
Percentage of Participants Who Achieve Two Consecutive iPTH Values Between 150 pg/mL to 300 pg/mL (16.5 - 33.0 Pmol/L) During Dosing Period 20
SecondaryPercentage of Participants Who Achieve Two Consecutive iPTH Values Between 150 pg/mL to 300 pg/mL (16.5 - 33.0 Pmol/L) During Dosing Periods 1 and 2 Combined

Participants who achieve two consecutive iPTH values between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) will be evaluated.

Time frame:
Up to Week 24
Reported as:
Number · percentage of participants
Percentage of Participants Who Achieve Two Consecutive iPTH Values Between 150 pg/mL to 300 pg/mL (16.5 - 33.0 Pmol/L) During Dosing Periods 1 and 2 Combined
percentage of participantsParticipants Receiving Paricalcitol
Percentage of Participants Who Achieve Two Consecutive iPTH Values Between 150 pg/mL to 300 pg/mL (16.5 - 33.0 Pmol/L) During Dosing Periods 1 and 2 Combined50
SecondaryIncidence of Hypercalcemia During Dosing Period 2

Incidence of hypercalcemia is defined as two consecutive, post-baseline, corrected calcium measurements above the normal participants's age-specific upper limit.

Time frame:
Week 12 through Week 24
Reported as:
Count of participants · Participants
Incidence of Hypercalcemia During Dosing Period 2
ParticipantsParticipants Receiving Paricalcitol
Incidence of Hypercalcemia During Dosing Period 20
SecondaryIncidence of Hypercalcemia During Dosing Periods 1 and 2 Combined

Incidence of hypercalcemia is defined as two consecutive, post-baseline, corrected calcium measurements above the normal participants's age-specific upper limit.

Time frame:
Up to Week 24
Reported as:
Count of participants · Participants
Incidence of Hypercalcemia During Dosing Periods 1 and 2 Combined
ParticipantsParticipants Receiving Paricalcitol
Incidence of Hypercalcemia During Dosing Periods 1 and 2 Combined0

Adverse events

Collected over All-cause mortality and adverse event tables include AEs reported from the time of informed consent and treatment-emergent events reported from the time of study drug administration to the end of the study. The median time on follow-up was 146 days for participants receiving paricalcitol.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Participants Receiving Paricalcitol0/2 (0%)2/2 (100%)1/2 (50%)
Most frequent serious events
Most frequent serious events
EventParticipants Receiving Paricalcitol
DEVICE RELATED BACTERAEMIAInfections and infestations1/2
DEVICE RELATED INFECTIONInfections and infestations1/2
RESPIRATORY SYNCYTIAL VIRUS INFECTIONInfections and infestations1/2
HYPERNATRAEMIAMetabolism and nutrition disorders1/2
TONIC CONVULSIONNervous system disorders1/2
Most frequent other events
Most frequent other events
EventParticipants Receiving Paricalcitol
GASTROINTESTINAL INFLAMMATIONGastrointestinal disorders1/2
PERITONITISInfections and infestations1/2
ASTHMARespiratory, thoracic and mediastinal disorders1/2
VANCOMYCIN INFUSION REACTIONSkin and subcutaneous tissue disorders1/2

Baseline characteristics

Age, Customized
Age, Customized(Participants)Participants Receiving Paricalcitol
< 2 years0
2 to 9 years2
Sex: Female, Male
Sex: Female, Male(Participants)Participants Receiving Paricalcitol
Female1
Male1
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Participants Receiving Paricalcitol
Hispanic or Latino1
Not Hispanic or Latino1
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Participants Receiving Paricalcitol
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White2
More than one race0
Unknown or Not Reported0
07

Study locations

15 sites
  • Arkansas Children's Hospital /ID# 225417
    Little Rock, Arkansas 72202, United States
  • Stanford University School of Medicine - Redwood City /ID# 252150
    Redwood City, California 94063, United States
  • Childrens National Medical Center /ID# 225991
    Washington D.C., District of Columbia 20010-2916, United States
  • Holtz Childrens Hospital, University of Miami /ID# 225636
    Miami, Florida 33136-1005, United States
  • Nicklaus Children's Hospital /ID# 210517
    Miami, Florida 33155-3009, United States
  • Emory University /ID# 140665
    Atlanta, Georgia 30322-1014, United States
  • Augusta University Medical Center /ID# 252149
    Augusta, Georgia 30912-0004, United States
  • Boston Children's Hospital /ID# 162863
    Boston, Massachusetts 02115, United States
  • Duplicate_Levine Children's Specialty Center- Charlotte /ID# 216057
    Charlotte, North Carolina 28203-5866, United States
  • Atrium Health Wake Forest Baptist Medical Center /ID# 266045
    Winston-Salem, North Carolina 27157, United States
  • Children's Hospital of Philadelphia - Main /ID# 213802
    Philadelphia, Pennsylvania 19104-4319, United States
  • University of Texas Southwestern Medical Center /ID# 210495
    Dallas, Texas 75390-7208, United States
  • University of Utah /ID# 140669
    Salt Lake City, Utah 84112-5500, United States
  • Seattle Children's Hospital /ID# 162861
    Seattle, Washington 98105, United States
  • School of Medicine University of Puerto Rico-Medical Science Campus /ID# 140663
    San Juan, 00935, Puerto Rico
08

References and documents

Study documents

  • Study protocol · Jul 13, 2023
  • Statistical analysis plan · Nov 7, 2025

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

Individual participant data

Plan to share: Yes — AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Supporting information: Study protocol, Sap, Csr

09

Registry details

Key details

Study ID
NCT04064827
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Aug 22, 2019
Start date
Sep 16, 2020
Primary completion
Jun 9, 2025
Completion
Jun 9, 2025
Results posted
Jun 15, 2026
Last update
Jun 15, 2026

Study contacts

ABBVIE INC.
study director · AbbVie

Oversight

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

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