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Clinical trial

An Open-Label, Repeated-Dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of Oral CTAP101 Capsules, Immediate- Release (IR) Calcifediol, High-Dose Cholecalciferol, and Paricalcitol Plus Low-Dose Cholecalciferol in Patients With Secondary Hyperparathyroidism, Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency

NCT03588884 is registered in ClinicalTrials.gov with OPKO Health, Inc. as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
An Open-Label, Repeated-Dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of Oral CTAP101 Capsules, Immediate- Release (IR) Calcifediol, High-Dose Cholecalciferol, and Paricalcitol Plus Low-Dose Cholecalciferol in Patients With Secondary Hyperparathyroidism, Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency
Lead sponsor
OPKO Health, Inc.
Phase
Phase 4
Overall status
Completed
Start date
June 8, 2018
Completion date
April 24, 2020
Enrollment
69 (actual)
Sites
3

Conditions

As the registry lists them; a condition with its own page is linked.

ckd stage 3, ckd stage 4, secondary hyperparathyroidism due to renal causes, vitamin d insufficiency