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)

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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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

16 participants in 1 patient group

Participants Receiving Paricalcitol
Experimental group
Description:
Participants will be administered paricalcitol three times a week (TIW) but no more frequently than every other day for 24 weeks
Treatment:
Drug: Paricalcitol

Trial contacts and locations

13

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Central trial contact

ABBVIE CALL CENTER

Data sourced from clinicaltrials.gov

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