Status:
COMPLETED
Safety Study of CTA018 Injection to Treat Stage 5 Chronic Kidney Disease
Lead Sponsor:
OPKO IP Holdings II, Inc.
Conditions:
Chronic Kidney Disease
Secondary Hyperparathyroidism
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This study will investigate the levels of CTA018 in the body over time (pharmacokinetics, PK) in patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT), undergoing regular...
Eligibility Criteria
Inclusion
- Body mass index between 18 and 35
- On maintenance hemodialysis three times per week
- Serum iPTH value greater than or equal to 300 pg/mL and lower than or equal to 1000 pg/mL
- Adjusted or total serum calcium value greater than or equal to 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 or equal to 15 ng/mL
- Willing and able to discontinue vitamin D and/or bone metabolism therapy for at least 2 weeks prior to administration of Study Drug, and the length of study
Exclusion
- On bisphosphonates for at least three months prior to first dose of Study Drug
- Currently taking cytochrome P450 3A inhibitors and/or inducers
- Abnormal liver functions
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00742716
Start Date
October 1 2008
End Date
June 1 2010
Last Update
November 6 2014
Active Locations (12)
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1
Pines Clinical Research, Inc.
Pembroke Pines, Florida, United States, 33028
2
Boise Kidney and Hypertension Institute
Meridian, Idaho, United States, 83642
3
Western New England Renal & Transplant Associates (WNERTA)
Springfield, Massachusetts, United States, 01107-1121
4
Southeast Renal Research Institute
Chattanooga, Tennessee, United States, 37404