Clinical Trial Details
| Trial ID: | L0474 |
| Source ID: | NCT00742716 |
| Associated Drug: | Cta018 Injection |
| Title: | Safety Study of CTA018 Injection to Treat Stage 5 Chronic Kidney Disease |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Chronic Kidney Disease|Secondary Hyperparathyroidism|Chronic Renal Insufficiency|Chronic Renal Failure |
| Interventions: | DRUG: CTA018 Injection |
| Outcome Measures: | Primary: To assess the single and repeat dose pharmacokinetics (PK) of CTA018 Injection, Day 1 and 12 of each dose level|To investigate the safety of CTA018 Injection, Throughout the study | Secondary: To investigate the pharmacodynamic (PD) intact parathyroid hormone (iPTH) response following CTA08 Injection, Throughout the study|To determine the efficacy of CTA018 Injection to reduce serum iPTH, Throughout the study |
| Sponsor/Collaborators: | Sponsor: OPKO IP Holdings II, Inc. |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 41 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2008-10 |
| Completion Date: | 2010-06 |
| Results First Posted: | |
| Last Update Posted: | 2014-11-06 |
| Locations: | Pines Clinical Research, Inc., Pembroke Pines, Florida, 33028, United States|Boise Kidney and Hypertension Institute, Meridian, Idaho, 83642, United States|Western New England Renal & Transplant Associates (WNERTA), Springfield, Massachusetts, 01107-1121, United States|Southeast Renal Research Institute, Chattanooga, Tennessee, 37404, United States|U.S. Renal Care, Fort Worth, Texas, 76105, United States|Capital District Heatlth Authority: Centre for Clinical Research, Halifax, Nova Scotia, B3H 1V8, Canada|St. Joseph's Health Care London, London, Ontario, N6A 4V2, Canada|St. Michael's Hospital, Toronto, Ontario, M5N 1W8, Canada|Humber River Regional Hospital, Weston, Ontario, M9N 1N8, Canada|Hôpital Charles-Lemoyne, Greenfield Park, Quebec, J4V 2H1, Canada|Hôpital du Sacré-Coeur de Montréal, Montreal, Quebec, H4J 1C5, Canada|Hospital de Verdun, Verdun, Quebec, H4G 2A3, Canada |
| URL: | https://clinicaltrials.gov/show/NCT00742716 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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