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

Vitamin D Insufficiency Clinical Trial

Official 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

Status Completed

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

CKD Stage 3
CKD Stage 4
Hyperparathyroidism
Hyperparathyroidism, Secondary
Kidney Diseases
Neoplasm Metastasis
Renal Insufficiency, Chronic
Secondary Hyperparathyroidism Due to Renal Causes
Vitamin D Insufficiency

Clinical Trial Details

NCT number	NCT03588884
Study type	Interventional
Source	OPKO Health, Inc.
Contact
Status	Completed
Phase	Phase 4
Start date	June 8, 2018
Completion date	April 24, 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02187146` - The Effects of Serum Vitamin D and IVF Outcome	N/A
Completed	`NCT01219855` - Safety/Efficacy Study of CTAP101 in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism (SHPT)	Phase 2/Phase 3
Completed	`NCT01596842` - Effect of Omega-3 Fatty Acid on Vitamin D Activation	Phase 4
Completed	`NCT01375660` - D Vitamin Intervention in VA	N/A
Active, not recruiting	`NCT03621553` - Vitamin D Homeostasis in Sarcoidosis	Phase 4
Terminated	`NCT02212652` - Vitamin D to Improve Nutrition Prior to Bariatric Surgery and Investigate the Relationship With Negative Outcomes	N/A
Completed	`NCT01179503` - Vitamin D Supplementation and Physical Function in Older Adults	Early Phase 1
Completed	`NCT04780776` - Evaluating the Effect of Solius UV Light Source in Improving Vitamin D Status	N/A
Completed	`NCT04735926` - Efficacy and Safety of Calcifediol vs Placebo in Subjects With Vitamin D Deficiency	Phase 2/Phase 3
Completed	`NCT00812578` - Metabolic Effects of Vitamin D in Patients With Type 2 Diabetes	Phase 2
Completed	`NCT00273611` - Vitamin D Levels and Vitamin D Education in Geriatric Patients	N/A
Completed	`NCT02856776` - Gene Expression, Metabolomic, Microbiome, and Calcium Metabolism in Response to Varied Vitamin D Dosages	N/A
Completed	`NCT04865432` - Solius UV Light Source in Improving Serum Levels of 25-hydroxyvitamin D	N/A
Completed	`NCT01349127` - Trial to Assess Vitamin D Requirements in Lactating Women	N/A
Completed	`NCT00690417` - Vitamin D Inadequacy in Rural Populations, Evaluation of Correction by Food Supplementation	N/A
Completed	`NCT03660800` - Pharmacokinetics and Safety Study of CTAP101 Capsules in Japanese and Non-Japanese Healthy Subjects and Non-Japanese Healthy Subjects	Phase 1