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Safety/Efficacy Study of CTAP101 in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism (SHPT) | Clinical Trials | Clareo Health

COMPLETEDPHASE2/PHASE3

Safety/Efficacy Study of CTAP101 in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism (SHPT)

A Randomized, Double Blind, Placebo-Controlled, Repeat Dose, Safety, Efficacy and Pharmacokinetic/Pharmacodynamic Study of CTAP101 Capsules in Subjects With Chronic Kidney Disease, Vitamin D Insufficiency and Secondary Hyperparathyroidism

NCT01219855•OPKO Health, Inc.

View on ClinicalTrials.gov

Summary

This study will investigate how the levels of a repeat dose of CTAP101 changes in the body over time (pharmacokinetics, PK) and how CTAP101 affects other mineral and hormonal balances (pharmacodynamics, PD) in patients with chronic kidney disease (CKD, vitamin D insufficiency and secondary hyperparathyroidism (SHPT).

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Urinary albumin excretion of ≤3000 μg of creatinine
•2. Stage 3 CKD
•3. Plasma iPTH: \> 70 pg/mL and \< 500 pg/mL
•4. Serum Ca: ≥ 8.4 mg/dL and \< 10.0 mg/dL
•5. Serum P: ≥ 2.0 mg/dL and \< 5.0 mg/dL
•6. Serum 25-hydroxyvitamin D: \> 10 ng/mL and \< 29 ng/mL.
•7. Discontinue vitamin D use for duration of study

Exclusion Criteria

•1. History of kidney transplant or parathyroidectomy
•2. Spot urine calcium:creatinine ratio \> 0.2
•3. Current serious illness, such as malignancy, HIV, liver disease, cardiovascular event or hepatitis
•4. Currently on dialysis

Locations (1)

OPKO Health, Inc

Bannockburn, Illinois, United States

Key Dates

Start Date

October 1, 2010

Primary Completion Date

November 1, 2011

Completion Date

November 1, 2011

Last Updated

August 25, 2016

Enrollment

ACTUAL participants

Conditions

Chronic Kidney DiseaseSecondary HyperparathyroidismVitamin D Insufficiency

Interventions

Cohort 1 CTAP101 Capsules- 60µg

DRUG

Cohort 1 CTAP101 Capsules - 90µg

DRUG

Cohort 1 Matching Sugar Capsule

DRUG

Cohort 2 CTAP101 Capsules - 30µg

DRUG

Cohort 2 Matching Sugar Capsule

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 25, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety/Efficacy Study of CTAP101 in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism (SHPT)

Inclusion Criteria

Exclusion Criteria

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