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)

AbbVie

Status and phase

Enrolling

Phase 3

Conditions

Chronic Kidney Disease (CKD)

Secondary Hyperparathyroidism (SHPT)

Treatments

Drug: Paricalcitol

Study type

Interventional

Funder types

Industry

Identifiers

NCT04064827

M11-617

Details and patient eligibility

About

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).

Enrollment

16 estimated patients

Sex

All

Ages

Under 9 years old

Volunteers

No Healthy Volunteers

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 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.