Clinical Trial Details
| Trial ID: | L1371 |
| Source ID: | NCT00238043 |
| Associated Drug: | Biogeneric Epoetin |
| Title: | Cohort Study to Determine the Long-Term Safety and Efficacy of Biogeneric Epoetin Treatment for Renal Anemia |
| Acronym: | |
| Status: | UNKNOWN |
| Study Results: | NO |
| Results: | |
| Conditions: | Chronic Kidney Disease|End-Stage Renal Failure|Anaemia |
| Interventions: | DRUG: Biogeneric Epoetin |
| Outcome Measures: | Primary: To investigate the Hb levels at each every 3 months follow up visit and the incidence of lack anticipated Hb response or loss of response to Biogeneric Epoetin. To monitor the occurrence of PRCA and other immunogenicity related adverse event. | Secondary: Mortality, quality of life and cost during the 6 years study treatment. |
| Sponsor/Collaborators: | Sponsor: Ministry of Health, Malaysia |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 2000 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC |
| Start Date: | 2005-08 |
| Completion Date: | 2011-04 |
| Results First Posted: | |
| Last Update Posted: | 2008-06-17 |
| Locations: | Pahang Buddhist Association, Kuantan, Pahang, Malaysia|Pusat Hemodialisis Islam Makmur, Kuantan, Pahang, Malaysia|SP Menon Dialysis Centre, Klang, Selangor, Malaysia|Tan Medical Renal Clinic, Petaling Jaya, Selangor, Malaysia|SP Menon Dialysis Centre, PJ, Selangor, Malaysia|Klinik Pakar Dialysis, Subang Jaya, Selangor, Malaysia|Sunway Medical Centre, Subang Jaya, Selangor, Malaysia|The Kidney Dialysis Centre, KL, Wilayah Persekutuan, Malaysia|Aiman Dialysis Centre, Kuala Lumpur, Wilayah Persekutuan, Malaysia|Ampang Putri Specialist Hospital, Kuala Lumpur, Wilayah Persekutuan, Malaysia|Cheras Dialysis Centre, Kuala Lumpur, Wilayah Persekutuan, Malaysia|Gleneagles Intan Medical Centre, Kuala Lumpur, Wilayah Persekutuan, Malaysia|Pantai Medical Centre, Kuala Lumpur, Wilayah Persekutuan, Malaysia|Smartcare Dialysis Centre, Kuala Lumpur, Wilayah Persekutuan, Malaysia|The Kidney Dialysis Centre, Kuala Lumpur, Wilayah Persekutuan, Malaysia |
| URL: | https://clinicaltrials.gov/show/NCT00238043 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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