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)

  • STATUS
    Recruiting
  • End date
    Apr 30, 2026
  • participants needed
    16
  • sponsor
    AbbVie
Updated on 26 September 2021
vitamin d
nephropathy
dialysis
paricalcitol
vitamin
hyperparathyroidism
chronic kidney disease stage 5
ergocalciferol
secondary hyperparathyroidism
kidney disease

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).

Details
Condition chronic renal insufficiency, Hyperparathyroidism, Chronic renal failure, Secondary hyperparathyroidism, Hyperparathyroidism (Pediatric), chronic kidney disease, chronic kidney disease (ckd)
Treatment Paricalcitol
Clinical Study IdentifierNCT04064827
SponsorAbbVie
Last Modified on26 September 2021

Eligibility

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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