Status:
TERMINATED
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)
Lead Sponsor:
AbbVie
Conditions:
Chronic Kidney Disease (CKD)
Secondary Hyperparathyroidism (SHPT)
Eligibility:
All Genders
Up to 9 years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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 more than \> 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.
Key Trial Info
Start Date :
September 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 9 2025
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04064827
Start Date
September 16 2020
End Date
June 9 2025
Last Update
December 4 2025
Active Locations (15)
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1
Arkansas Children's Hospital /ID# 225417
Little Rock, Arkansas, United States, 72202
2
Stanford University School of Medicine - Redwood City /ID# 252150
Redwood City, California, United States, 94063
3
Childrens National Medical Center /ID# 225991
Washington D.C., District of Columbia, United States, 20010-2916
4
Holtz Childrens Hospital, University of Miami /ID# 225636
Miami, Florida, United States, 33136-1005