Safety and Efficacy of Paricalcitol Capsules in decreasing serum parathyroid hormone levels in children 10-16 with Chronic Kidney Disease (CKD)
- Conditions
- Moderate to Severe Chronic Kidney DiseaseMedDRA version: 17.1Level: LLTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 100000004857Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
- Registration Number
- EUCTR2010-019439-37-PT
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 36
1. Male or female subjects = 10 years old and = 16 years old.
2. Subject has voluntarily signed and dated an informed consent form and/or assent, or has had one signed by a parent or legal guardian, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature of the study has been explained and the subject and/or parent or legal guardian has had the opportunity to ask questions. The informed consent must be signed prior to any study-specific procedures being performed.
3. Subject has CKD Stage 3 or 4 as determined by eGFR (15 to 59 mL/min/1.73 m2) at Screening.
4. Part II Subjects who have had a kidney or solid organ transplant = 12 months prior to entry into the Treatment Phase with a stable, therapeutic calcineurin inhibitor drug level (at least two stable levels prior to enrollment into Part II of the study).
5. Subject has 25-hydroxyvitamin D levels = 30 ng/mL at Screening (Part II Only).
6. Subject is not expected to begin dialysis for at least 6 months (in the opinion of the investigator).
7. If taking phosphate binders, the subject has been on a stable dose (same type and regimen) for at least 4 weeks prior to the Screening Phase.
8. If receiving growth hormone, subject must be receiving it for > 3 months prior to the Screening Phase and expected to continue to receive it throughout the Treatment Phase.
9. All female subjects must have a negative pregnancy test prior to Treatment.
10. Female subjects must not be nursing, must use the following methods of contraception upon enrollment, and must continue to use these methods for the duration of the study:
? Double barrier method (any two of the following: condoms, contraceptive sponges, diaphragm, vaginal ring with spermicidal jellies or creams, or intrauterine device [IUD]).
? Hormonal contraceptives (oral, parenteral or transdermal) for 3 months prior to study drug administration.
? Females on stable (same dose and product for 3 months) estrogen or progestin therapy (not for contraception).
? Total abstinence from sexual intercourse during the study (minimum one complete menstrual cycle prior to study start).
11. To satisfy the Screening criteria (for subjects who are currently on a VDRA and need to complete a 2–4 week washout), the subject must have:
? eGFR between 15 to 59 mL/min/1.73 m2 (estimate by the Schwartz formula as outlined in Section 5.3.1.2).
? iPTH measurement that is = 60 pg/mL (Stage 3 subjects) or = 90 pg/mL (Stage 4 subjects).
? An adjusted serum calcium value = 8.2 mg/dL (2.05 mmol/L) to = 10.5 mg/dL (2.63 mmol/L).
? A serum phosphorus value = 2.0 mg/dL (0.65 mmol/L) to = 6.0 mg/dL (1.94 mmol/L).
12. For entry into the Treatment Phase (VDRA naïve subjects and those who have completed a 2–4 week washout), the subject must have:
? iPTH measurement that is = 75 pg/mL (Stage 3 subjects) or = 110 pg/mL (Stage 4 subjects).
? An adjusted serum calcium value = 8.4 mg/dL (2.10 mmol/L) to = 10.2 mg/dL (2.55 mmol/L).
? A serum phosphorus value = 2.5 mg/dL (0.81 mmol/L) to = 5.8 mg/dL (1.87 mmol/L).
? Must have Vitamin 25D level that is = 30 ng/mL (Part II Only).
Are the trial subjects under 18? yes
Number of subjects for this age range: 36
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
1. Subject has a history of an allergic reaction or significant sensitivity to paricalcitol or to drugs similar to the study drug.
2. Part I Subjects: All transplants except bone marrow transplant recipients (off immunosuppressant therapy).
3. Subjects who have had a small bowel transplant.
4. Subject has had acute kidney failure within 12 weeks of the Screening Phase (defined as an acute rise in serum creatinine).
5. Subject has had symptomatic or significant hypocalcemia requiring active Vitamin D therapy (i.e., calcitriol, paricalcitol, doxercalciferol or alfacalcidol) within 6 months prior to the Screening Phase.
6. Subject has a history of active kidney stones (6 months prior to screening).
7. Subject has chronic gastrointestinal disease, which in the investigator's opinion may cause significant gastrointestinal malabsorption.
8. Subject is taking maintenance calcitonin, bisphosphonates, cinacalcet,
glucocorticoids in an equivalent dose of > 5 mg prednisone daily, or other drugs known to affect calcium or bone metabolism within 4 weeks prior to Treatment.
9. Subject is taking phosphate supplements.
10. Subject has a current malignancy (except for basal/squamous cell carcinoma) or clinically significant liver disease, in the opinion of the investigator.
11. Subject weighs < 25 kg (55 lbs.).
12. Subject has a history of illicit drug and/or alcohol abuse within 6 months prior to the Screening Phase or a positive urine drug test at Screening. Positive urine drug tests at screening which are due to controlled drugs prescribed for a medical need are not exclusionary.
13. Subject has evidence of poor compliance with diet or medication that may interfere, in the investigator's opinion, with adherence to the protocol.
14. Subject has received any investigational drug within 4 weeks prior to the Screening Phase.
15. Subject is known to be HIV positive.
16. For any reason, subject is considered by the investigator to be an unsuitable candidate (i.e., unable to swallow capsules, lack of a telephone) to receive paricalcitol capsules or is put at risk by the study procedures.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method