A Phase 3, Open-Label, Multicenter Study to Evaluate the Safety of Paricalcitol Capsules in Pediatric Subjects Ages 10 to 16 with Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis

Study ID
STU 042011-098

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Children's Medical Center-Dallas

Contact
DEBORAH MCELROY

deborah.mcelroy@childrens.com

Principal Investigator
Raymond Quigley

Summary

This is a Phase 3, open-label, single-arm, multicenter study evaluating the tolerability and safety of paricalcitol capsules in pediatric subjects with Stage 5 CKD receiving peritoneal dialysis. a sufficient number of sites in the uS will be selected to enroll 12 subjects. all eligible subjects will be assigned to the single paricalcitol arm. The paricalcitol dose will be adjusted as described in Section 5.5.4, in order to maintain an iPTH level between 150 to 300 pg/mL.The study will be performed in three Periods: 1) Screening 2) Washout 3) Dosing. The study is designed to enroll 12 subjects to meet scientific and regulatory objectives without enrolling an undue number of subjects in alignment with ethical considerations.


Participant Eligibility

1. Subject must be receiving peritoneal dialysis or hemodialysis for at least 3 months prior to
Screening.
2. Male or female subject between 10 and 16 years of age, inclusive at the time of
Screening.
3. Subject is currently being diagnosed and/or treated for secondary hyperparathyroidism.
4. If taking phosphate binders, the subject has been on a stable dose (same type and
regimen) for at least 2 weeks prior to Screening.
5. If receiving growth hormone, subject must be receiving it for at least 3 months
prior to Screening and is expected to remain on a stable dose (same type and
regimen) throughout the study.
6. If female, subject is not breastfeeding.
7. If female, subject must have a negative serum pregnancy test at Screening.
8. If female, subject is either not of childbearing potential, defined as pre-menstrual,
or is of childbearing potential and practicing one of the following methods of birth
control:

* Double barrier method (any two of the following: condoms, contraceptive
sponge, diaphragm or vaginal ring with spermicidal jellies or creams, or
intrauterine device [IUD]).

* Hormonal contraceptives (oral, parenteral or transdermal) for at least
3 months prior to and during study drug administration.

* Total abstinence from sexual intercourse during the study (minimum
one complete menstrual cycle prior to Day 1 of the Dosing Period).
9. For entry into the Washout Period (for subjects who are currently on a VDR
Activator and need to complete a 2 to 12 week washout), the subject must meet the
following laboratory criteria:

* A corrected calcium value >= 8.2 (2.05 mmol/L) and <= 10.5 mg/dL (2.63 mmol/L)

* A phosphorus value <= 6.5 mg/dL (2.1 mmol/L)

* An iPTH value >= 130 pg/mL (13.7 pmol/L) and <= 2000 pg/mL (210.6 pmol/L)
10. For entry into the Dosing Period (for subjects that are naive to VDR Activators or
those who have completed a 2 to 12 week washout), the subject must meet the
following laboratory criteria prior to enrollment:

* A corrected calcium value >= 8.4 mg/dL (2.10 mmol/L) and <= 10.2 mg/dL (2.55 mmol/L)

* A phosphorus value <= 6.5 mg/dL (2.1 mmol/L)

* An iPTH value > 300 pg/mL (31.6 pmol/L) and <= 2000 pg/mL (210.6 pmol/L)
11. The subject has provided voluntary assent and the subject's parent/legal
representative has voluntarily signed and dated an informed consent form,
approved by an Institutional Review Board (IRB)/Independent Ethics Committee
(IEC), after the nature of the study has been explained and the subject and
parent/legal guardian has had the opportunity to ask questions. The informed
consent/assent must be signed prior to the conduct of any study specific Screening
procedures or withholding any medications.