NCT03588884View on ClinicalTrials.gov

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

PHASE4CompletedINTERVENTIONAL
Enrollment

69

Participants

Timeline

Start Date

June 8, 2018

Primary Completion Date

April 24, 2020

Study Completion Date

April 24, 2020

Conditions
Secondary Hyperparathyroidism Due to Renal CausesVitamin D InsufficiencyCKD Stage 3CKD Stage 4
Interventions
DRUG

Calcifediol Oral Capsule

Capsule, daily

DRUG

Calcifediol Oral Product

Capsule, once a month

DRUG

Cholecalciferol

Capsule, once a month

DRUG

Paricalcitol Oral Capsule

Capsule, daily

Trial Locations (3)

53095

Spaulding Clinical Research, West Bend

60643

Research by Design, LLC, Chicago

92844

National Institute of Clinical Research, Inc., Garden Grove

All Listed Sponsors
lead

OPKO Health, Inc.

INDUSTRY

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 | Biotech Hunter | Biotech Hunter