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
1 other identifier
interventional
28
1 country
12
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2009
Shorter than P25 for phase_1
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2009
CompletedFirst Posted
Study publicly available on registry
April 24, 2009
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedSeptember 30, 2014
February 1, 2010
6 months
April 23, 2009
September 29, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the PK and bioavailability of CTAP101 in Stage 3 and 4 CKD subjects with vitamin D insufficiency and SHPT
from 3 to 0 hours prior to dosing until 42 days post dosing
Secondary Outcomes (2)
To assess the safety and tolerability of CTAP101 capsules and injection
From signing of ICF (Day -35) through study completion (Day 42 post dosing)
To assess the pharmacodynamics of single dose CTAP101 in Stage 3 and Stage 4 CKD subjects with vitamin D insufficiency and SHPT.
From signing of ICF (Day -35) through study completion (Day 42 post dosing)
Study Arms (3)
Low Dose CTAP101 Capsules
EXPERIMENTALCTAP101 Capsules, 450 mcg dose
High Dose CTAP101 Capsules
EXPERIMENTALCTAP101 Capsules, 900 mcg dose
CTAP101 Injection
EXPERIMENTALIV injection, 448 mcg dose
Interventions
Single dose oral administration
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Pivotal Research Centers
Peoria, Arizona, 85381, United States
Research by Design
Evergreen Park, Illinois, 60805, United States
Western New England Renal & Transplant Associates
Springfield, Massachusetts, 01107, United States
Twin Cities Clinical Research
Brooklyn Center, Minnesota, 55430, United States
DCI
Cincinnati, Ohio, 45206, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109-1998, United States
Northeast Clinical Research
Allentown, Pennsylvania, 18103, United States
Southeast Renal Research Institute
Chattanooga, Tennessee, 37404, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Southwest Houston Research Ltd
Houston, Texas, 77099, United States
Purity Dialysis Centers / Nephrology Associates
Delafield, Wisconsin, 53018, United States
Gunderson Clinic Ltd.
La Crosse, Wisconsin, 54601, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Joel Melnick, MD
OPKO Renal
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2009
First Posted
April 24, 2009
Study Start
May 1, 2009
Primary Completion
November 1, 2009
Study Completion
December 1, 2009
Last Updated
September 30, 2014
Record last verified: 2010-02