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Clinical Trial Details

Trial ID: L0512
Source ID: NCT04155125
Associated Drug: Efepoetin Alfa
Title: A Study of Efepoetin Alfa in Treating Anaemia Associated With Chronic Kidney Diseases Patient
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Anaemia Associated With Chronic Kidney Disease
Interventions: DRUG: efepoetin alfa|DRUG: Mircera
Outcome Measures: Primary: To assess the efficacy of efepoetin alfa in the treatment of anaemia associated with CKD as measured by haemoglobin (Hb) response rate at the end of correction treatment evaluation period, Measurement is done by an increase in Hb more than or equal to 1 g/dL compared with baseline and a Hb concentration within range of 10 - 12 g/dL inclusive without transfusion during evaluation period, Measurement from the date of Randomization till the End of the Corrective Treatment period, assessed up to 20 weeks. | Secondary: Characterise safety and tolerability of subcutaneous efepoetin alfa is being measured by based on the frequency of adverse events and on the number of out of range laboratory values., Safety endpoints parameters including Serious Adverse Events (SAE) specified below 1. Composite outcome of cardiovascular death or a nonfatal myocardial infarction or stroke 2. All-cause mortality 3. Cardiovascular mortality 4. Acute myocardial infarction 5. Heart failure 6. Acute kidney injury defined according to Acute Kidney Injury Network (AKIN) criteria 7. Abnormal clinical laboratory tests (haematology, biochemistry including serum ferritin and TSAT) 8. Anti-efepoetin alfa or anti-Mircera antibody titres 9. Clinically meaningful abnormal findings of vital signs 10. Development of clinically meaningful electrocardiogram abnormalities 11. Hospitalisations (excluding those for logistic reasons) It is a composite outcome. Any abnormal test findings during the study will be helpful in reviewing the outcome., Measurement from the time the subject provides informed consent through and including 28 calendar days after the last study drug administration.
Sponsor/Collaborators: Sponsor: PT Kalbe Genexine Biologics | Collaborators: Novotech (Australia) Pty Limited
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 391
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2020-07-02
Completion Date: 2023-06-30
Results First Posted:
Last Update Posted: 2023-12-22
Locations: Renal Research Gosford, Gosford, New South Wales, 2250, Australia|Royal Adelaide Hospital, Adelaide, South Australia, 5000, Australia|Launceston General Hospital, Launceston, Tasmania, 7250, Australia|Rspad Gatot Soebroto, Jakarta Pusat, Indonesia|Rumah Sakit Islam Jakarta Cempaka Putih, Jakarta Pusat, Indonesia|Rumah Sakit Islam Jakarta Pondok Kopi, Jakarta Pusat, Indonesia|Rumah Sakit Pgi Cikini, Jakarta Pusat, Indonesia|Rumah Sakit Umum Pusat Fatmawati, Jakarta Pusat, Indonesia|Rumah Sakit Umum Pusat Nasional Dr Cipto Mangunkusumo, Jakarta Pusat, Indonesia|Chungnam National University Hospital, Daejeon, Korea, Republic of|Korea University Ansan Hospital, Gyeonggi-do, Korea, Republic of|Seoul National University Bundang Hospital, Gyeonggi-do, Korea, Republic of|The Catholic University of Korea Incheon St. Mary'S Hospital, Incheon, Korea, Republic of|Chungnam National University Sejong Hospital, Sejong, Korea, Republic of|Kyung Hee University Hospital At Gangdong, Seoul, Korea, Republic of|The Catholic University of Korea Eunpyeong St. Mary'S Hospital, Seoul, Korea, Republic of|The Catholic University of Korea Seoul St. Mary'S Hospital, Seoul, Korea, Republic of|The Catholic University of Korea, Yeouido St. Mary'S Hospital, Seoul, Korea, Republic of|Seri Manjung Hospital, Seri Manjung, Perak, 32040, Malaysia|University of Malaya Medical Centre, Kuala Lumpur, Selangor, 59100, Malaysia|Hospital Raja Permaisuri Bainun, Ipoh, 30450, Malaysia|Hospital Kajang, Kajang, 43000, Malaysia|Hospital Raja Perempuan Zainab II, Kota Bharu, 15200, Malaysia|Hospital Kuala Lumpur, Kuala Lumpur, 50586, Malaysia|Hospital Tengku Ampuan Afzan, Kuantan, 25100, Malaysia|Hospital Serdang, Serdang, 43000, Malaysia|Hospital Sibu, Sibu, 96000, Malaysia|M3 Dialysis Center, Bacolod City, 6100, Philippines|Baguio General Hospital Medical Center, Baguio, 2600, Philippines|Norzel Medical and Diagnostic Clinic, Cebu City, 6000, Philippines|De La Salle Medical and Health Sciences Institute, Dasmariñas, 4114, Philippines|Davao Doctors Hospital, Davao City, 8000, Philippines|West Visayas State University Hospital, Iloilo City, 5000, Philippines|National Kidney and Transplant Institute, Quezon, 1101, Philippines|Changhua Christian Hospital, Changhua, 100, Taiwan|Hualien Tzu Chi Hospital, Hualien City, 970, Taiwan|Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, 80756, Taiwan|Kaohsiung Veterans General Hospital, Kaohsiung, 813, Taiwan|Kaohsiung Chang Gung Hospital, Kaohsiung, 83301, Taiwan|Keelung Chang Gung Memorial Hospital, Keelung, 204, Taiwan|Taiching Veterans General Hospital, Taichung, 40705, Taiwan|Kuang Tien General Hospital, Taichung, 433, Taiwan|Chi Mei Medical Center, Tainan, 433, Taiwan|National Cheng Kung University Hospital, Tainan, 704, Taiwan|National Taiwan University Hospital, Taipei, 100, Taiwan|Tri-Service General Hospital, Taipei, 114, Taiwan|Far Eastern Memorial Hospital, Taipei, 220, Taiwan|Taipei Medical University - Shuang Ho Hospital, Taipei, 235, Taiwan|Linkou Chang Gung Memorial Hospital, Taoyuan, 833, Taiwan|Vajira Hospital, Bangkok, 10330, Thailand|Siriraj Hospital, Bangkok, 10700, Thailand|Maharaj Nakorn Chiang Mai Hospital, Chiang Mai, 50200, Thailand|Thammasat University Hospital, Pathum Thani, 12120, Thailand|Songklanagarind Hospital, Songkhla, 90110, Thailand|Sunpasitthiprasong Hospital, Ubon Ratchathani, 34000, Thailand
URL: https://clinicaltrials.gov/show/NCT04155125

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