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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: OPKO Health, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-06-08
• Primary completion: 2020-04-24
• Completion: 2020-04-24
• First posted: 2018-07-17
• Last updated: 2022-12-09
• Results posted: 2022-12-09

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study