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Clinical Trial Details

Trial ID: L0496
Source ID: NCT00229099
Associated Drug: Gerepo
Title: Efficacy and Safety Study of GerEPO
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Chronic Renal Failure Related Anemia
Interventions: DRUG: GerEPO
Outcome Measures: Primary: To establish the therapeutic equivalence of GerEpo with the standard treatment Eprex® for a treatment period of 12 weeks in patients on Hemodialysis with respect to hemoglobin response. | Secondary: • To compare GerEpo with Eprex® with respect to their respective frequency of adverse events|To monitor the occurrence of PRCA and other immunogenicity related adverse events among patients on GerEpo observed for at least a year on therapy.
Sponsor/Collaborators: Sponsor: Ministry of Health, Malaysia
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 270
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2005-04
Completion Date: 2005-11
Results First Posted:
Last Update Posted: 2006-10-26
Locations: Hospital Sultanah Aminah, Johor Bharu, Johor, 80100, Malaysia|Pontian Rotary Haemodialysis Centre, Pontian, Johor, 82000, Malaysia|Hospital Alor Setar, Alor Setar, Kedah, 05100, Malaysia|Hospital Kota Bharu, Kota Bharu, Kelantan, 15590, Malaysia|Pusat Hemodialisis Mawar (Seremban), Seremban, Negeri Sembilan, 70300, Malaysia|Seremban General Hospital, Seremban, Negeri Sembilan, 70300, Malaysia|Hospital Tengku Ampuan Afzan, Kuantan, Pahang, Malaysia|Pahang Buddhist Association, Kuantan, Pahang, Malaysia|Hospital Ipoh, Ipoh, Perak, 30990, Malaysia|Hospital Taiping, Taiping, Perak, 34000, Malaysia|Hospital Kangar, Kangar, Perlis, 01000, Malaysia|Asia Renal Care,Bukit Mertajam, Bukit Mertajam, Pulau Pinang, 14000, Malaysia|Persatuan Buah Pinggang Sabah, Kota Kinabalu, Sabah, 88100, Malaysia|Hospital Queen Elizabeth, Kota Kinabalu, Sabah, 88586, Malaysia|Timberland Medical Centre, Kuching, Sarawak, 93250, Malaysia|MAA Medicare Kidney Charity Dialysis Centre, Kuching, Sarawak, 93540, Malaysia|Hospital Umum Sarawak, Kuching, Sarawak, 93586, Malaysia|Ampang Putri Specialist Hospital, Ampang, Selangor, Malaysia|Hospital Selayang, Batu Caves, Selangor, Malaysia|Hospital Tengku Ampuan Rahimah, Klang, Selangor, 41200, Malaysia|SP Menon Dialysis Centre, Klang, Selangor, Malaysia|Haemodialysis Unit , Sunway Medical Centre, Petaling Jaya, Selangor, 46150, Malaysia|SP Menon Dialysis Centre, Megah Medical Specialist Centre, PJ, Selangor, Malaysia|Hospital Kuala Terengganu, Kuala Terengganu, Terengganu, 20400, Malaysia|SP Menon Dialysis Centre, Kuala Lumpur, Wilayah Persekutuan, 50400, Malaysia|Pusat Hemodialisis, Yayasan Felda, Kuala Lumpur, Wilayah Persekutuan, 54000, Malaysia|The Kidney Dialysis Centre, Kuala Lumpur, Wilayah Persekutuan, 58100, Malaysia|Pantai Medical Centre, Kuala Lumpur, Kuala Lumpur, Wilayah Persekutuan, 59100, Malaysia|Hospital Kuala Lumpur, Kuala Lumpur, Wilayah Persekutuan, Malaysia|Tung Shin Hospital, Kuala Lumpur, Wilayah Persekutuan, Malaysia|Hospital Melaka, Melaka, 75400, Malaysia|Penang General Hospital, Pulau Pinang, 10990, Malaysia
URL: https://clinicaltrials.gov/show/NCT00229099

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