Safety and Efficacy of CTAP101 Capsules for Treatment of SHPT and Vitamin D Insufficiency



Status:Completed
Conditions:Food Studies, Other Indications, Renal Impairment / Chronic Kidney Disease, Endocrine, Gastrointestinal
Therapuetic Areas:Endocrinology, Gastroenterology, Nephrology / Urology, Pharmacology / Toxicology, Other
Healthy:No
Age Range:18 - 85
Updated:4/21/2016
Start Date:November 2012
End Date:September 2014

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Trial Summary
Trial Overview
Inclusion Criteria

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of CTAP101 Capsules to Treat Secondary Hyperparathyroidism in Subjects With Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency

This study will evaluate the efficacy of CTAP101 Capsules versus placebo in reducing intact
parathyroid hormone (iPTH) by at least 30% from pretreatment baseline; safety and
tolerability of CTAP101 will also be evaluated

Approximately 210 stage 3 or 4 CKD subjects with SHPT and vitamin D insufficiency will be
randomized to either CTAP101 Capsules or matching placebo for 6 months of treatment.

Inclusion Criteria:

1. Urinary albumin excretion ≤ 3000 mcg/mg of creatinine

2. Stage 3 or 4 CKD

3. Plasma iPTH: ≥ 85 pg/mL and < 500 pg/mL

4. Serum Ca: ≥ 8.4 mg/dL and < 9.8 mg/dL

5. Serum P: ≥ 2.0 mg/dL and < 5.0 mg/dL

6. Serum 25-hydroxyvitamin D: ≥ 10 ng/mL and < 30 ng/mL.

7. Stable dose of Vitamin D therapy ≤ 1600 IU/day and receiving same dose for at least 2
months

Exclusion Criteria:

1. History of kidney transplant or parathyroidectomy

2. Spot urine calcium:creatinine ratio > 0.2 (>200 mg/g Cr)

3. Current serious illness, such as malignancy, HIV, liver disease, cardiovascular event
or hepatitis

4. Currently on dialysis

5. Use of pharmacological dose of ergocalciferol or cholecalciferol (≥ 50,000 IU mcg per
month) during the study
We found this trial at
1
site
OPKO Renal
Bannockburn, Illinois 60015
?
mi
from
Bannockburn, IL
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