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CTAP101 for Chronic Kidney Disease

Not yet recruiting at 4 trial locations
OH
Overseen ByOPKO Health
Age: < 18
Sex: Any
Trial Phase: Phase 2
Sponsor: OPKO Health, Inc.
Must not be taking: Calcimimetics, Calcifediol, Bisphosphonates, Denosumab
Disqualifiers: Kidney transplant, Malignancy, HIV, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to evaluate safety, tolerability, and how CTAP101 Capsules work to treat Pediatric Participants with Secondary Hyperparathyroidism, Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency. The main questions it aims to answer are:

1. To assess the pharmacokinetics (PK) and Pharmacodynamics (PD) of CTAP101 Capsules

2. To investigate the safety and tolerability of CTAP101 Capsules

Participants will take a daily dosage of CTAP101 Capsules at bedtime for 8 weeks.

Are You a Good Fit for This Trial?

Inclusion Criteria

I was diagnosed with stage 3 or 4 chronic kidney disease at least six months ago.
Participant must be without any disease state or physical condition that might impair evaluation of safety or study participation
Participant must exhibit specific laboratory values during initial or screening visit
See 7 more

Exclusion Criteria

I do not have any serious illnesses or abnormal heart or physical conditions.
Participant must not have history of neurological/psychiatric disorder that may affect treatment adherence
I have not had a kidney transplant or rejection in the past 26 weeks.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take a daily dosage of CTAP101 Capsules at bedtime for 8 weeks

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • CTAP101

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Cohort 1 - Group BExperimental Treatment1 Intervention
Group II: Cohort 1 - Group AExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

OPKO Health, Inc.

Lead Sponsor

Trials
48
Recruited
5,100+

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