Back to resultsComparison of I.V. CTAP201 and Doxercalciferol (Hectorol) in Subjects With Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism (SHPT)
Primary Purpose
Chronic Kidney Disease, Secondary Hyperparathyroidism, Chronic Renal Insufficiency
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CTAP201 Injection
Doxercalciferol
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Parathyroid Diseases, Renal Insufficiency, Kidney Failure, Chronic, Hyperparathyroidism, Secondary, Vitamin D, Hyperparathyroidism, Renal Insufficiency, Chronic, Kidney Diseases, Kidney Failure
Eligibility Criteria
Inclusion Criteria:
- Body mass index between 18 and 40
- On maintenance hemodialysis three times per week
- Visit 1: Serum iPTH value greater than or equal to 200 pg/mL and lower than or equal to 1000 pg/mL
- Visit 1: Serum total calcium value greater than 8.4 mg/dL and lower than 10.0 mg/dL
- Visit 1: 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 or equal to 15 ng/mL
- Visit 2: Serum iPTH value greater than 300 pg/mL
- Visit 2: Serum Ca x P product less than 56 [mg/dl]2
- Willing and able to discontinue vitamin D and/or bone metabolism therapy for at least 2 weeks prior to administration of Study Drug, and length of study
Exclusion Criteria:
- Taking cytochrome P450 3A inhibitors and/or inducers
- Abnormal liver functions
Sites / Locations
- Pivotal Reseach Centers
- Western New England Renal and Transplant Associates
- University of Cincinnati
- Northeast Clinical Research
- Vanderbilt University
- Southwest Houston Research Ltd.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Active Comparator
Arm Label
CTAP201 Injection at dose a
CTAP201 Injection
Doxercalciferol at dose a
Doxercalciferol
Arm Description
CTAP201 at dose a
CTAP201 at dose b or dose c
Active at dose a
Active at dose b or dose c
Outcomes
Primary Outcome Measures
Blood levels of CTAP201 and doxercalciferol
Safety of a single dose of CTAP201 Injection
Secondary Outcome Measures
Full Information
NCT ID
NCT00792857
First Posted
November 14, 2008
Last Updated
September 26, 2014
Sponsor
OPKO IP Holdings II, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00792857
Brief Title
Comparison of I.V. CTAP201 and Doxercalciferol (Hectorol) in Subjects With Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism (SHPT)
Official Title
Single-Dose, Two-Period, Open Label, Dose Determination, Randomized, Cross-Over Study of CTAP201 Injection and Doxercalciferol (Hectorol) Injection in Subjects With Stage 5 CKD and SHPT on Hemodialysis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OPKO IP Holdings II, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will compare CTAP201 with Doxercalciferol in patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT), undergoing regular hemodialysis, at different dose strengths. This study will also investigate the levels of CTAP201 in the body over time and determine the safety of CTAP201.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Secondary Hyperparathyroidism, Chronic Renal Insufficiency, Chronic Renal Failure
Keywords
Parathyroid Diseases, Renal Insufficiency, Kidney Failure, Chronic, Hyperparathyroidism, Secondary, Vitamin D, Hyperparathyroidism, Renal Insufficiency, Chronic, Kidney Diseases, Kidney Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CTAP201 Injection at dose a
Arm Type
Experimental
Arm Description
CTAP201 at dose a
Arm Title
CTAP201 Injection
Arm Type
Experimental
Arm Description
CTAP201 at dose b or dose c
Arm Title
Doxercalciferol at dose a
Arm Type
Active Comparator
Arm Description
Active at dose a
Arm Title
Doxercalciferol
Arm Type
Active Comparator
Arm Description
Active at dose b or dose c
Intervention Type
Drug
Intervention Name(s)
CTAP201 Injection
Intervention Description
Comparison of different dose strengths of CTAP201 after single dose.
Intervention Type
Drug
Intervention Name(s)
Doxercalciferol
Other Intervention Name(s)
Hectorol
Intervention Description
Comparison of different dose strengths of doxercalciferol after single dose.
Primary Outcome Measure Information:
Title
Blood levels of CTAP201 and doxercalciferol
Time Frame
Day 1 and Day 15 of each dose level
Title
Safety of a single dose of CTAP201 Injection
Time Frame
Throughout the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Body mass index between 18 and 40
On maintenance hemodialysis three times per week
Visit 1: Serum iPTH value greater than or equal to 200 pg/mL and lower than or equal to 1000 pg/mL
Visit 1: Serum total calcium value greater than 8.4 mg/dL and lower than 10.0 mg/dL
Visit 1: 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 or equal to 15 ng/mL
Visit 2: Serum iPTH value greater than 300 pg/mL
Visit 2: Serum Ca x P product less than 56 [mg/dl]2
Willing and able to discontinue vitamin D and/or bone metabolism therapy for at least 2 weeks prior to administration of Study Drug, and length of study
Exclusion Criteria:
Taking cytochrome P450 3A inhibitors and/or inducers
Abnormal liver functions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Melnick, MD
Organizational Affiliation
OPKO Renal
Official's Role
Study Director
Facility Information:
Facility Name
Pivotal Reseach Centers
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Western New England Renal and Transplant Associates
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45206
Country
United States
Facility Name
Northeast Clinical Research
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103-6379
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Southwest Houston Research Ltd.
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of I.V. CTAP201 and Doxercalciferol (Hectorol) in Subjects With Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism (SHPT)
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