Clinical trial NCT00229099: Efficacy and Safety Study of GerEPO
Official title: A Randomized, Multi-Center, Open Label Trial to Establish the Therapeutic Equivalence Between GerEpo and Eprex® and to Determine the Long Term Safety Profile of GerEpo in Patients on Hemodialysis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Renal Failure Related Anemia
Lead sponsor: Ministry of Health, Malaysia
Sponsor class: OTHER_GOV
First posted: 2005-09-29
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to establish the equivalence of GerEpo with the standard treatment Eprex® for a treatment period of 12 weeks in patients on Hemodialysis with respect to hemoglobin response and to establish the longer-term safety profile of GerEpo, with special regards for the occurrence of Pure Red Cell Aplasia (PRCA) and other immunogenicity related adverse event

Detailed description: 270 patients on Hemodialysis from 25 participating sites who meet inclusion/exclusion criteria will be enrolled into the trial. At the end of the comparative trial, subjects on either arm of the study may opt to enter a longer term cohort study designed to establish the longer-term safety profile of GerEpo, with special regards for the occurrence of Pure Red Cell Aplasia (PRCA) and other immunogenicity related adverse event.

This second part of the study is also opened to all subjects who have given written informed consent, and have ESRF with CRF related anemia who according to current guideline should be treated with Epoetin. Subjects need not be included in the first part of the study.

All patients shall be treated with GerEpo and thereafter observed for at least 1 year to actively monitor for the occurrence of PRCA and other immunogenicity related adverse events. The cohort study shall continue until at least 10,000 patient-years of observation have accrued on the study database.

Eligibility criteria: Inclusion Criteria:

1. Written informed consent obtained.
2. Patients age between 18 and 70 years.
3. Patients who are medically stable on hemodialysis for a minimum of 3 months.
4. Patients on Eprex® treatment for CRF related anemia and maintaining Hb level at or above 9 g/dL(90g/L) while on a stable dose (no change in dose) of Epoetin within 6 weeks preceding the screening phase of this study.
5. Patients who have a serum ferritin level greater than 100μg/L and/or transferrin saturation at least 20% within 3 months preceding the screening phase of this study.

Exclusion Criteria:

1. Pregnant or nursing woman, or women of childbearing potential without an effective method of birth control. Effective birth control methods are oral contraception, Norplant, surgical sterilization, IUD or diaphragms in conjunction with spermicidal foam and condom on the male partner.
2. Participation in any drug trial in which the patient received an Epoetin investigational drug within 30 days preceding the screening phase of this study.
3. Those persons directly involved in the conduct of the study.
4. Poorly controlled hypertension with diastolic blood pressures persistently greater than 110 mmHg at baseline observation.
5. History of seizure disorder.
6. Active acute or chronic infection or inflammatory disease.
7. Any illness that had required hospitalization within the last one month.
8. Had blood transfusion within the last three months.
9. Significant hematologic abnormalities (Evidence of hemolysis by laboratory tests, unexplained acquired microcytosis, thrombocytosis (\>500,000/mm3))
10. Severe hyperparathyroidism
11. Diagnosed to have malignant tumor or who have residual tumor after anti-cancer therapy.

Primary outcomes:
measure: 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 outcomes:
measure: • To compare GerEpo with Eprex® with respect to their respective frequency of adverse events
measure: To monitor the occurrence of PRCA and other immunogenicity related adverse events among patients on GerEpo observed for at least a year on therapy.
Other outcomes:
Locations:
city: Johor Bharu
country: Malaysia
facility: Hospital Sultanah Aminah
state: Johor
city: Pontian
country: Malaysia
facility: Pontian Rotary Haemodialysis Centre
state: Johor
city: Alor Setar
country: Malaysia
facility: Hospital Alor Setar
state: Kedah
city: Kota Bharu
country: Malaysia
facility: Hospital Kota Bharu
state: Kelantan
city: Seremban
country: Malaysia
facility: Pusat Hemodialisis Mawar (Seremban)
state: Negeri Sembilan
city: Seremban
country: Malaysia
facility: Seremban General Hospital
state: Negeri Sembilan
city: Kuantan
country: Malaysia
facility: Hospital Tengku Ampuan Afzan
state: Pahang
city: Kuantan
country: Malaysia
facility: Pahang Buddhist Association
state: Pahang
city: Ipoh
country: Malaysia
facility: Hospital Ipoh
state: Perak
city: Taiping
country: Malaysia
facility: Hospital Taiping
state: Perak
city: Kangar
country: Malaysia
facility: Hospital Kangar
state: Perlis
city: Bukit Mertajam
country: Malaysia
facility: Asia Renal Care,Bukit Mertajam
state: Pulau Pinang
city: Kota Kinabalu
country: Malaysia
facility: Persatuan Buah Pinggang Sabah
state: Sabah
city: Kota Kinabalu
country: Malaysia
facility: Hospital Queen Elizabeth
state: Sabah
city: Kuching
country: Malaysia
facility: Timberland Medical Centre
state: Sarawak
city: Kuching
country: Malaysia
facility: MAA Medicare Kidney Charity Dialysis Centre
state: Sarawak
city: Kuching
country: Malaysia
facility: Hospital Umum Sarawak
state: Sarawak
city: Ampang
country: Malaysia
facility: Ampang Putri Specialist Hospital
state: Selangor
city: Batu Caves
country: Malaysia
facility: Hospital Selayang
state: Selangor
city: Klang
country: Malaysia
facility: Hospital Tengku Ampuan Rahimah
state: Selangor
city: Klang
country: Malaysia
facility: SP Menon Dialysis Centre
state: Selangor
city: Petaling Jaya
country: Malaysia
facility: Haemodialysis Unit , Sunway Medical Centre
state: Selangor
city: PJ
country: Malaysia
facility: SP Menon Dialysis Centre, Megah Medical Specialist Centre
state: Selangor
city: Kuala Terengganu
country: Malaysia
facility: Hospital Kuala Terengganu
state: Terengganu
city: Kuala Lumpur
country: Malaysia
facility: SP Menon Dialysis Centre
state: Wilayah Persekutuan
city: Kuala Lumpur
country: Malaysia
facility: Pusat Hemodialisis, Yayasan Felda
state: Wilayah Persekutuan
city: Kuala Lumpur
country: Malaysia
facility: The Kidney Dialysis Centre
state: Wilayah Persekutuan
city: Kuala Lumpur
country: Malaysia
facility: Pantai Medical Centre, Kuala Lumpur
state: Wilayah Persekutuan
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
state: Wilayah Persekutuan
city: Kuala Lumpur
country: Malaysia
facility: Tung Shin Hospital
state: Wilayah Persekutuan
city: Melaka
country: Malaysia
facility: Hospital Melaka
city: Pulau Pinang
country: Malaysia
facility: Penang General Hospital
Study officials:
affiliation: Ministry of Health
name: Zaki Morad, MRCP, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goh BL, Ong LM, Sivanandam S, Lim TO, Morad Z; Biogeneric EPO Study Group. Randomized trial on the therapeutic equivalence between Eprex and GerEPO in patients on haemodialysis. Nephrology (Carlton). 2007 Oct;12(5):431-6. doi: 10.1111/j.1440-1797.2007.00831.x.