Clinical Trial Details
| Trial ID: | L1192 |
| Source ID: | NCT00202345 |
| Associated Drug: | Iron Sucrose |
| Title: | Iron Sucrose in Stage 3/4 Kidney Disease |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Kidney Failure|Anemia |
| Interventions: | DRUG: Iron sucrose |
| Outcome Measures: | Primary: The primary endpoint will be the change in Hb concentration at 12 months or termination (dialysis, commencement of an ESA). Minimum permitted enrolment is 6 months. | Secondary: The secondary endpoints will be the change in renal function (calculated creatinine clearance), the quality of life, the time taken to dialysis, the time from randomization to the requirement of an ESA and the number of hospitalization days. |
| Sponsor/Collaborators: | Sponsor: Melbourne Health |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 120 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2004-08 |
| Completion Date: | 2007-02 |
| Results First Posted: | |
| Last Update Posted: | 2015-05-05 |
| Locations: | Central Coast Health, Gosford, New South Wales, 2250, Australia|Royal North Shore Hospital, St Leonards, New South Wales, 2065, Australia|Royal Brisbane & Women's Hospital, Herston, Queensland, 4006, Australia|Monash Medical Centre, Clayton, Victoria, 3168, Australia|The Royal Melbourne Hospital, Melbourne, Victoria, 3050, Australia|Royal Perth Hospital, Perth, Western Australia, 6847, Australia |
| URL: | https://clinicaltrials.gov/show/NCT00202345 |
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