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Vitamin D Analog

CTAP101 Capsules 600mcg/weekly for Chronic Kidney Disease

Phase 2

Waitlist Available

Research Sponsored by OPKO Health, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 74 weeks

Awards & highlights

Study Summary

This trial is testing a new drug, CTAP101, to see if it is safe and effective in treating secondary hyperparathyroidism (SHPT) in patients undergoing dialysis.

Eligible Conditions

Chronic Kidney Disease
Renal Disease
Secondary Hyperparathyroidism
Vitamin D Deficiency

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 74 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~74 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 74 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change of mean plasma intact parathyroid hormone (iPTH)

Increase mean serum total 25-hydroxyvitamin D

Maximum Plasma Concentration [Cmax]

+1 more

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: CTAP101 Capsules 600mcg/weeklyActive Control1 Intervention

CTAP101 Oral Capsules/Calcifediol, calcidiol, 25-hydroxyvitamin D3, 600mcg/weekly for 26 weeks

Group II: CTAP101 Capsules 900mcg/weeklyActive Control1 Intervention

CTAP101 Oral Capsules/Calcifediol, calcidiol, 25-hydroxyvitamin D3, 900mcg/weekly for 26 weeks

Group III: CTAP101 Capsules 300mcg/weeklyActive Control1 Intervention

CTAP101 Oral Capsules/Calcifediol, calcidiol, 25-hydroxyvitamin D3, 300mcg/weekly for 26 weeks

Group IV: Placebo Capsules weeklyPlacebo Group1 Intervention

Placebo Oral Capsules/weekly for 26 weeks

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

OPKO Health, Inc.Lead Sponsor

47 Previous Clinical Trials

5,194 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are taking part in the experiment?

"Unfortunately, this medical study is not currently seeking participants as of May 9th 2022. Originally posted July 9th 2018, it has since been edited on the same date. However, there are 1181 trials actively looking for patients with vitamin d deficiency and 3 studies recruiting volunteers to be administered CTAP101 Capsules 600mcg/weekly."

Answered by AI

Have previous research trials examined the effects of CTAP101 Capsules 600mcg/weekly?

"Initially, CTAP101 Capsules 600mcg/weekly was experimented with in 2015 at Hospital Infanta Elena. To date, 192 trials have been finished and 3 are still ongoing mostly concentrated around San Dimas, California."

Answered by AI

What medical conditions are typically alleviated with a regimen of CTAP101 Capsules 600mcg/weekly?

"CTAP101 Capsules 600mcg/weekly can be employed to treat vitamin d deficiency between 10 ng/ml and 30 ng/ml, as well as stages 3 and 4 of chronic kidney disease."

Answered by AI

How widespread is the accessibility of this research project?

"North America Research Institute, Inc. located in San Dimas, California; Research by Design, LLC based out of Chicago, Illinois; and AKDHC Medical Research Services situated in Phoenix Arizona are just a few of the 17 participating clinical trial sites."

Answered by AI

Has the FDA issued a stamp of approval for CTAP101 Capsules 600mcg/weekly?

"CTAP101 Capsules 600mcg/weekly has been given a safety rating of 2 due to the supporting data collected from Phase 2 trials. While there is evidence that this medication may be safe, no efficacy-related studies have yet been conducted."

Answered by AI

Are enrollees still being accepted for this clinical experiment?

"Currently, no new candidates are being admitted to this trial which was first posted on July 9th 2018 and last edited May 9th 2022. However, if you search for other trials there are 1181 studies accepting participants who have vitamin d deficiency as well as 3 clinical trials recruiting patients that will use CTAP101 Capsules 600mcg/weekly."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2018. "Safety, Efficacy, PK and PD of CTAP101 (Calcifediol) ER Capsules for SHPT in HD Patients VDI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03602261.