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)
Reason given: Company Decision
Key facts
- Where
- Atlanta, Augusta, Boston, Charlotte, Dallas, Little Rock, Miami, Philadelphia, Redwood City, Salt Lake City, Seattle, Washington D.C., and Winston-Salem, United StatesSee the 14 sites
- Phase
- Phase 3
Where in United States
- Emory University /ID# 140665Atlanta, United StatesNo longer taking part
- Augusta University Medical Center /ID# 252149Augusta, United StatesNo longer taking part
- Boston Children's Hospital /ID# 162863Boston, United StatesNo longer taking part
- Duplicate_Levine Children's Specialty Center- Charlotte /ID# 216057Charlotte, United StatesNo longer taking part
- University of Texas Southwestern Medical Center /ID# 210495Dallas, United StatesNo longer taking part
- Arkansas Children's Hospital /ID# 225417Little Rock, United StatesNo longer taking part
- Holtz Childrens Hospital, University of Miami /ID# 225636Miami, United StatesNo longer taking part
- Nicklaus Children's Hospital /ID# 210517Miami, United StatesNo longer taking part
- Children's Hospital of Philadelphia - Main /ID# 213802Philadelphia, United StatesNo longer taking part
- Stanford University School of Medicine - Redwood City /ID# 252150Redwood City, United StatesNo longer taking part
- University of Utah /ID# 140669Salt Lake City, United StatesNo longer taking part
- Seattle Children's Hospital /ID# 162861Seattle, United StatesNo longer taking part
- Childrens National Medical Center /ID# 225991Washington D.C., United StatesNo longer taking part
- Atrium Health Wake Forest Baptist Medical Center /ID# 266045Winston-Salem, United StatesNo longer taking part
Trial details
- Who runs it
- AbbVie
- Trial code
- NCT04064827
- Record updated
- 15 June 2026
- Original description
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).Read full original descriptionShow less
A Phase 3, Prospective, Open-Label, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Paricalcitol Oral Solution for the Treatment of Secondary Hyperparathyroidism in Pediatric Subjects Ages 0 to 9 Years With Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis
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).
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 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; Participant is expected to discontinue peritoneal dialysis (PD) or hemodialysis (HD) within 3 months of the initial Screening visit.