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)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AbbVie
Age
0–9
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | 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)
