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)

  • End date
    Oct 30, 2026
  • participants needed
  • sponsor
Updated on 3 May 2022
vitamin d
chronic kidney disease stage 5
secondary hyperparathyroidism
kidney disease


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).

Condition Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism (SHPT)
Treatment Paricalcitol
Clinical Study IdentifierNCT04064827
Last Modified on3 May 2022


Yes No Not Sure

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

Participant is expected or scheduled to receive a kidney transplant within 6 months of Screening or is a kidney transplant recipient
Participant is expected to discontinue peritoneal dialysis (PD) or hemodialysis (HD) within 6 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
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