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Pharmacokinetics and Safety Pilot Study of Single-Dose Oral and Intravenous CTAP101 in Stage 3 and 4 Chronic Kidney Disease Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Pharmacokinetics and Safety Pilot Study of Single-Dose Oral and Intravenous CTAP101 in Stage 3 and 4 Chronic Kidney Disease Subjects

A Randomized, Open-Label, Single-Dose Pilot Study of Oral and i.v. CTAP101 Evaluating PK and Safety in Stage 3 and 4 CKD Subjects With Vitamin D Insufficiency and SHPT

NCT00888069•OPKO IP Holdings II, Inc.

View on ClinicalTrials.gov

Summary

This study will investigate how the levels of a single 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 Stage 3 or 4 chronic kidney disease (CKD) with vitamin D insufficiency and secondary hyperparathyroidism (SHPT).

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Body mass index between great than or equal to 18 and less than or equal to 40 kg/m2
•Plasma iPTH value for Stage 3 CKD greater than or equal to 70 pg/mL and lower than or equal to 1000 pg/mL
•Plasma iPTH value for Stage 4 CKD greater than or equal to 110 pg/mL and lower than or equal to 1000 pg/mL
•Adjusted serum total calcium value greater than 8.4 mg/dL and lower than 10.0 mg/dL
•Serum phosphorus value greater than or equal to 2.5 mg/dL and lower than or equal to 5.5 mg/dL
•Serum 25-hydroxyvitamin D level greater than 15 ng/mL and lower than 30 ng/mL
•Hemoglobin level greater than or equal to 10 g/dL

Exclusion Criteria

•Has nephrotic range proteinuria
•Has liver disease or significant hepatic dysfunction
•Is taking Cytochrome P450 3A4 inhibitors or inducers
•Has adult history of kidney stones and dysphagia
•Has known history of alcohol/controlled substance abuse or are positive for drug of abuse screen
•Currently on dialysis
•Current serious illness such as cancer, HIV, cardiovascular event or hepatitis

Locations (12)

Pivotal Research Centers

Peoria, Arizona, United States

Research by Design

Evergreen Park, Illinois, United States

Western New England Renal & Transplant Associates

Springfield, Massachusetts, United States

Twin Cities Clinical Research

Brooklyn Center, Minnesota, United States

DCI

Cincinnati, Ohio, United States

MetroHealth Medical Center

Cleveland, Ohio, United States

Northeast Clinical Research

Allentown, Pennsylvania, United States

Southeast Renal Research Institute

Chattanooga, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Southwest Houston Research Ltd

Houston, Texas, United States

Key Dates

Start Date

May 1, 2009

Primary Completion Date

November 1, 2009

Completion Date

December 1, 2009

Last Updated

September 30, 2014

Enrollment

ACTUAL participants

Conditions

Chronic Kidney DiseaseSecondary HyperparathyroidismChronic Renal InsufficiencyChronic Renal Failure

Interventions

CTAP101 Capsules

DRUG

CTAP101 Injection

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: September 30, 2014Data 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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Pharmacokinetics and Safety Pilot Study of Single-Dose Oral and Intravenous CTAP101 in Stage 3 and 4 Chronic Kidney Disease Subjects

Inclusion Criteria

Exclusion Criteria

A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)

A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Chronic Kidney Disease

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