← Back to Search

Vitamin D Analog

Vitamin D Treatment for Chronic Kidney Disease

Phase 3

Recruiting

Research Sponsored by OPKO Health, Inc.

Eligibility Criteria Checklist

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

Must have

Female subjects of childbearing potential must be neither pregnant nor lactating and must have a negative urine pregnancy test at the first screening visit.

If taking >1,000 mg/day of elemental calcium, discontinue or reduce calcium use and/or use non-calcium based therapies for the duration of the study.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 26 weeks

Awards & highlights

Study Summary

This trial studies if a vitamin D treatment helps children with kidney disease, high calcium and low vitamin D levels.

Who is the study for?

Children with stage 3-4 chronic kidney disease, secondary hyperparathyroidism, and vitamin D insufficiency can join. Ages 8-17 eligible; must meet specific lab value criteria like parathyroid hormone levels and serum calcium. They should not be on certain medications or have conditions that could affect the study.Check my eligibility

What is being tested?

The trial is testing CTAP101 capsules against a placebo to see if they're safe and effective for children with kidney disease-related bone issues due to low vitamin D. Participants are randomly assigned to either the treatment or placebo group without knowing which one they receive.See study design

What are the potential side effects?

While the side effects aren't listed here, generally, potential side effects in trials like this may include digestive discomfort, allergic reactions to ingredients, changes in blood levels of minerals and vitamins, or other unforeseen reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am not pregnant or breastfeeding and my pregnancy test was negative.

Select...

I am willing to stop or lower my calcium intake if it's more than 1,000 mg/day during the study.

Select...

I am willing to stop my vitamin D or cinacalcet treatment for the study.

Select...

I am willing to stop any bone treatments that might affect the study.

Select...

I am willing to adjust my vitamin D intake to ≤1,700 IU/day if it's currently higher.

Select...

I am taking ≤1,700 IU/day of vitamin D and can keep the dose the same during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 26 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~26 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 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

Numbers of subjects who attained mean decrease in plasma iPTH of 30% from baseline

Pharmacokinetic

Safety and tolerability

Secondary outcome measures

Hypercalcemia

Level of serum total 25-hydroxyvitamin D at ≥30 ng/mL compared to placebo

Pharmacodynamic effects of repeated doses of CTAP101 Capsules

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Cohort 1 and Cohort 2 CTAP101 CapsuleExperimental Treatment1 Intervention

Group II: Cohort 1 and Cohort 2 PlaceboPlacebo Group1 Intervention

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

OPKO Health, Inc.Lead Sponsor

47 Previous Clinical Trials

5,342 Total Patients Enrolled

2 Trials studying Vitamin D Deficiency

554 Patients Enrolled for Vitamin D Deficiency

Akhtar Ashfaq, MDStudy DirectorOPKO Health

Media Library

CTAP101 (Vitamin D Analog) Clinical Trial Eligibility Overview. Trial Name: NCT05543928 — Phase 3

Vitamin D Deficiency Research Study Groups: Cohort 1 and Cohort 2 CTAP101 Capsule, Cohort 1 and Cohort 2 Placebo

Vitamin D Deficiency Clinical Trial 2023: CTAP101 Highlights & Side Effects. Trial Name: NCT05543928 — Phase 3

CTAP101 (Vitamin D Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05543928 — Phase 3

Frequently Asked Questions

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

What are the major goals of this clinical trial?

"In the span of 26 weeks, this clinical trial will assess safety and tolerance as its primary outcome. Secondary assessments include pharmacodynamic effects (e.g., serum calcium, phosphorus, urine calcium:creatinine ratio), incidence of hypercalcemia/hyperphosphatemia events, and level of serum total 25-hydroxyvitamin D at ≥30 ng/mL compared to placebo."

Answered by AI

Am I eligible to partake in this clinical investigation?

"This medical trial is aiming to enrol 108 children between the ages of 8 and 17 with vitamin d deficiences. Some prerequisites must be met by participants, including but not limited to: having a body weight over 40kg for those aged 12-18 or 20kg+ for those aged 8-12; stage 3/4 chronic kidney disease diagnosis at least 6 months prior; serum albumin ≤3.0 g/dL; transaminase >2.5x upper limit normal range; 3000 mcg/mg creatinine urinary albumin excretion rate; iPTH (intact parathyroid hormone) 100 pg/mL"

Answered by AI

Is this experiment enrolling geriatric individuals?

"This trial is recruiting minors aged 8 to 17 years old."

Answered by AI

Are there opportunities for recruitment in this experiment?

"Affirmative. Information found on clinicaltrials.gov indicates that this experiment, initially published on January 31st 2023, is actively recruiting participants. 108 individuals are required from a single medical centre."

Answered by AI

What risks are associated with Cohort 1 and 2 of the CTAP101 Capsule treatment?

"Cohorts 1 and 2 of CTAP101 Capsule have been allocated a score of 3, signifying that its safety has already been evaluated through the completion of multiple phase 3 trials. There is also evidence that it may be effective at treating certain conditions."

Answered by AI

How many individuals are enrolled in this research endeavor?

"That is accurate. According to clinicaltrials.gov, recruitment for this trial commenced on January 31st 2023 and was recently updated on February 22nd 2023. The investigators need 108 patients from a single medical centre in order to proceed with the experiment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase 3 Safety and Efficacy Study of CTAP101 Extended-release Capsules in Children With Secondary Hyperparathyroidism

2023. "Phase 3 Safety and Efficacy Study of CTAP101 Extended-release Capsules in Children With Secondary Hyperparathyroidism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05543928.

All > Vitamin D Deficiency