Clinical Trial Details
| Trial ID: | L0607 |
| Source ID: | NCT00792857 |
| Associated Drug: | Ctap201 Injection |
| Title: | Comparison of I.V. CTAP201 and Doxercalciferol (Hectorol) in Subjects With Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism (SHPT) |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Chronic Kidney Disease|Secondary Hyperparathyroidism|Chronic Renal Insufficiency|Chronic Renal Failure |
| Interventions: | DRUG: CTAP201 Injection|DRUG: Doxercalciferol |
| Outcome Measures: | Primary: Blood levels of CTAP201 and doxercalciferol, Day 1 and Day 15 of each dose level|Safety of a single dose of CTAP201 Injection, Throughout the study | |
| Sponsor/Collaborators: | Sponsor: OPKO IP Holdings II, Inc. |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE1 |
| Enrollment: | 24 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2008-11 |
| Completion Date: | 2009-10 |
| Results First Posted: | |
| Last Update Posted: | 2014-09-29 |
| Locations: | Pivotal Reseach Centers, Peoria, Arizona, 85381, United States|Western New England Renal and Transplant Associates, Springfield, Massachusetts, 01107, United States|University of Cincinnati, Cincinnati, Ohio, 45206, United States|Northeast Clinical Research, Allentown, Pennsylvania, 18103-6379, United States|Vanderbilt University, Nashville, Tennessee, 37232, United States|Southwest Houston Research Ltd., Houston, Texas, 77099, United States |
| URL: | https://clinicaltrials.gov/show/NCT00792857 |
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