Status:
COMPLETED
Comparison of I.V. CTAP201 and Doxercalciferol (Hectorol) in Subjects With Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism (SHPT)
Lead Sponsor:
OPKO IP Holdings II, Inc.
Conditions:
Chronic Kidney Disease
Secondary Hyperparathyroidism
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
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 strength...
Eligibility Criteria
Inclusion
- 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
- Taking cytochrome P450 3A inhibitors and/or inducers
- Abnormal liver functions
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00792857
Start Date
November 1 2008
End Date
October 1 2009
Last Update
September 29 2014
Active Locations (6)
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1
Pivotal Reseach Centers
Peoria, Arizona, United States, 85381
2
Western New England Renal and Transplant Associates
Springfield, Massachusetts, United States, 01107
3
University of Cincinnati
Cincinnati, Ohio, United States, 45206
4
Northeast Clinical Research
Allentown, Pennsylvania, United States, 18103-6379