Pharmacokinetics and Safety Pilot Study of Single-Dose Oral and Intravenous CTAP101 in Stage 3 and 4 Chronic Kidney Disease Subjects
NCT ID: NCT00888069
Last Updated: 2014-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
28 participants
INTERVENTIONAL
2009-05-31
2009-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety/Efficacy Study of CTAP101 in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism (SHPT)
NCT01219855
Repeated-dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of CTAP101, Immediate-release Calcifediol, High-dose Cholecalciferol, and Paricalcitol Plus Low-dose Cholecalciferol in Patients With Secondary Hyperparathyroidism, Chronic Kidney Disease 3-4 and Vitamin D Insufficiency
NCT03588884
Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency
NCT01704079
Extension Study of CTAP101-CL-3001 or CTAP101-CL-3002
NCT02282813
Safety, Efficacy, PK and PD of CTAP101 (Calcifediol) ER Capsules for SHPT in HD Patients VDI
NCT03602261
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Low Dose CTAP101 Capsules
CTAP101 Capsules, 450 mcg dose
CTAP101 Capsules
Single dose oral administration
High Dose CTAP101 Capsules
CTAP101 Capsules, 900 mcg dose
CTAP101 Capsules
Single dose oral administration
CTAP101 Injection
IV injection, 448 mcg dose
CTAP101 Injection
single IV injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CTAP101 Capsules
Single dose oral administration
CTAP101 Injection
single IV injection
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
OPKO IP Holdings II, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Joel Melnick, MD
Role: STUDY_DIRECTOR
OPKO Renal
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Purity Dialysis Centers / Nephrology Associates
Delafield, Wisconsin, United States
Gunderson Clinic Ltd.
La Crosse, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CTAP101-CL-2004
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.