Study to Evaluate Safety of Vitamin D Receptor Activators in Patients Ages 0 to 16 With Chronic Kidney Disease Stage 5 Receiving Peritoneal Dialysis Within Current Clinical Practice

AbbVie

Status: Terminated

Conditions: End-Stage Renal Disease; Secondary Hyperparathyroidism

Treatments: Drug: Calcitriol; Drug: Paricalcitol

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT01134315

P12-053

Details and patient eligibility

About

The objective of this study was to observe the safety of paricalcitol utilization in pediatric participants (ages 0 to 16 years old) being treated for secondary hyperparathyroidism (SHPT). Participants were to be followed for a minimum of 3 months and up to approximately 36 months to monitor the incidence of hypercalcemia (high calcium levels in blood).

Full description

Investigators were free to determine the appropriate therapy for each participant based on clinical judgment. Decisions to prescribe paricalcitol or calcitriol were made independently prior to enrollment of participants in this observational study.

Enrollment: 61 patients

Sex: All

Ages: Under 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female between 0 to 16 years of age (inclusive), on peritoneal dialysis for at least 30 days.
2. The patient has a history of secondary hyperparathyroidism as defined by having initiated a vitamin D receptor activator to treat an elevated parathyroid hormone level.
3. The patient is attending a site associated with North America Pediatric Renal Trials and Collaborative Studies (NAPRTCS) Dialysis Registry.
4. Patient and the patient's parent or legal guardian must voluntarily sign and date an informed consent and/or assent, approved by the local Independent Ethics Committee/Institutional Review Board, prior to the initiation of any screening or study-specific procedures.
5. Patient has received paricalcitol or calcitriol for a minimum of 10 days.

Exclusion criteria

1. Patient is scheduled for a kidney transplant within 3 months.
2. Patient is expected to stop peritoneal dialysis within 3 months.
3. Patient is expected to transfer to hemodialysis within 3 months.
4. Patient is planning to be enrolled in an investigational study where the drug and/or dose are unknown to the investigator within the first 3 months from the date of patient enrollment.

Trial design

61 participants in 2 patient groups

Paricalcitol

Description:

Pediatric participants who received paricalcitol capsules to treat secondary hyperparathyroidism (SHPT). Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.

Treatment:

Drug: Paricalcitol

Calcitriol

Description:

Pediatric participants who received calcitriol to treat secondary hyperparathyroidism (SHPT). Calcitriol was prescribed by each physician under the usual and customary practice of that physician.

Treatment:

Drug: Calcitriol