Safety, Efficacy, PK and PD of CTAP101 (Calcifediol) ER Capsules for SHPT in HD Patients VDI

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Secondary Hyperparathyroidism Due to Renal Causes, Chronic Kidney Diseases, Vitamin D Deficiency, Stage 5 Chronic Kidney Disease

In brief

Safety, Efficacy, PK and PD of CTAP101 (calcifediol) ER Capsules for SHPT in HD Patients VDI

Key facts

Study ID

NCT03602261

Run by

OPKO Health, Inc.

People needed

44

Starts

2018-07-09

Expected to finish

2021-02-24

Last updated by the study team

2026-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Subjects who meet any of the following criteria will be excluded from the study:
• Scheduled kidney transplant or parathyroidectomy.
• History (prior 2 months) of corrected serum calcium ≥9.8 mg/dL or serum phosphorus
• ≥6.5 mg/dL if not receiving calcitriol or other 1α-hydroxylated vitamin D analog.
• Receipt of bisphosphonate therapy or other bone modifying treatment (eg, denosumab) within 6 months prior to enrollment.
• Known previous or concomitant serious illness or medical condition, such as malignancy, human immunodeficiency virus, significant gastrointestinal or hepatic disease, intestinal malabsorption disorder, hepatitis or cardiovascular event that in the opinion of the investigator may worsen or reduce life expectancy, and/or interfere with participation in the study.
• History of neurological/psychiatric disorder, including psychotic disorder or dementia, or any reason which, in the opinion of the investigator makes adherence to a treatment or follow-up schedule unlikely.
• Known or suspected hypersensitivity to any of the constituents of the study drugs.
• Currently participating in, or has participated in, an interventional/investigational study within 30 days prior to study screening.

Where it is running

• AKDHC Medical Research Services — Peoria, Arizona, United States
• AKDHC Medical Research Services — Phoenix, Arizona, United States
• AKDHC Medical Research Services — Phoenix, Arizona, United States
• AKDHC Medical Research Services — Phoenix, Arizona, United States
• WCCT Global, Inc. — Cypress, California, United States
• Hacienda Dialysis Center — Hacienda Heights, California, United States
• California Institute of Renal Research CKD/Dialysis & Transplant Division — La Mesa, California, United States
• Long Beach Quest Dialysis Center — Long Beach, California, United States
• Ontario Dialysis Center — Ontario, California, United States
• North America Research Institute, Inc. — San Dimas, California, United States
• Laurel Canyon Dialysis, LLC — Sun Valley, California, United States
• University of Colorado Denver Anschutz Medical Campus — Aurora, Colorado, United States
• Research by Design, LLC — Chicago, Illinois, United States
• Northshore University Health — Evanston, Illinois, United States
• Renal and Transplant Associates of New England — Springfield, Massachusetts, United States
• Southwest MS Nephrology — McComb, Mississippi, United States
• Southwest Houston Research LTD — Houston, Texas, United States
• Kidney & Hypertension Specialists — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.