Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OPKO IP Holdings II, Inc.
• Treatments: Calcifediol; Ergocalciferols; Vitamin D; Vitamins

Criteria

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