# Repeated-dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of CTAP101, Immediate-release Calcifediol, High-dose Cholecalciferol, and Paricalcitol Plus Low-dose Cholecalciferol in Patients With Secondary Hyperparathyroidism, Chronic Kidney Disease 3-4 and Vitamin D Insufficiency

> **NCT03588884** · PHASE4 · COMPLETED · sponsor: **OPKO Health, Inc.** · enrollment: 69 (actual)

## Conditions studied

- Secondary Hyperparathyroidism Due to Renal Causes
- Vitamin D Insufficiency
- CKD Stage 3
- CKD Stage 4

## Interventions

- **DRUG:** Calcifediol Oral Capsule
- **DRUG:** Calcifediol Oral Product
- **DRUG:** Cholecalciferol
- **DRUG:** Paricalcitol Oral Capsule

## Key facts

- **NCT ID:** NCT03588884
- **Lead sponsor:** OPKO Health, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE4
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2018-06-08
- **Primary completion:** 2020-04-24
- **Final completion:** 2020-04-24
- **Target enrollment:** 69 (ACTUAL)
- **Last updated:** 2022-12-09


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03588884

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03588884, "Repeated-dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of CTAP101, Immediate-release Calcifediol, High-dose Cholecalciferol, and Paricalcitol Plus Low-dose Cholecalciferol in Patients With Secondary Hyperparathyroidism, Chronic Kidney Disease 3-4 and Vitamin D Insufficiency". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT03588884. Licensed CC0.

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