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

> **NCT01651000** · PHASE3 · COMPLETED · sponsor: **OPKO IP Holdings II, Inc.** · enrollment: 213 (actual)

## Conditions studied

- Chronic Kidney Disease
- Hyperparathyroidism, Secondary
- Vitamin D Deficiency

## Interventions

- **DRUG:** CTAP101 30 μg capsules
- **OTHER:** Sugar pill to CTAP101 30 μg capsules

## Key facts

- **NCT ID:** NCT01651000
- **Lead sponsor:** OPKO IP Holdings II, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2012-09
- **Primary completion:** 2014-07
- **Final completion:** 2014-07
- **Target enrollment:** 213 (ACTUAL)
- **Last updated:** 2025-01-13


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01651000

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01651000, "Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency". Retrieved via AI Analytics 2026-06-08 from https://api.ai-analytics.org/clinical/NCT01651000. Licensed CC0.

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