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Chronic Renal Failure Related AnemiaPhase 3NCT00229099

Efficacy and Safety Study of GerEPO

A Phase 3 study testing GerEPO in people with Chronic Renal Failure Related Anemia, run by Ministry of Health, Malaysia at 32 sites in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Chronic Renal Failure Related Anemia
What is being tested?
GerEPO
How many people
270 participants
Where
32 sitesMalaysia
Study dates
Apr 2005to Nov 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent obtained.
  • Patients age between 18 and 70 years.
  • Patients who are medically stable on hemodialysis for a minimum of 3 months.
  • 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.
  • 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.

Who cannot join

  • 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.
  • Participation in any drug trial in which the patient received an Epoetin investigational drug within 30 days preceding the screening phase of this study.
  • Those persons directly involved in the conduct of the study.
  • Poorly controlled hypertension with diastolic blood pressures persistently greater than 110 mmHg at baseline observation.
  • History of seizure disorder.
  • Active acute or chronic infection or inflammatory disease.
Show all 11Show fewer
  • Any illness that had required hospitalization within the last one month.
  • Had blood transfusion within the last three months.
  • Significant hematologic abnormalities (Evidence of hemolysis by laboratory tests, unexplained acquired microcytosis, thrombocytosis (>500,000/mm3))
  • Severe hyperparathyroidism
  • Diagnosed to have malignant tumor or who have residual tumor after anti-cancer therapy.

Trial locations and contacts

32 sites in 1 country.

32 sites in 1 country

Malaysia32 sites

  • Hospital Alor Setar

    Alor Star, Kedah, 05100

  • Ampang Putri Specialist Hospital

    Ampang, Selangor

  • Hospital Selayang

    Batu Caves, Selangor

  • Asia Renal Care,Bukit Mertajam

    Bukit Mertajam, Pulau Pinang, 14000

  • Hospital Ipoh

    Ipoh, Perak, 30990

  • Hospital Sultanah Aminah

    Johor Bharu, Johor, 80100

  • Hospital Kangar

    Kangar, Perlis, 01000

  • Hospital Tengku Ampuan Rahimah

    Klang, Selangor, 41200

  • SP Menon Dialysis Centre

    Klang, Selangor

  • Hospital Kota Bharu

    Kota Bharu, Kelantan, 15590

  • Persatuan Buah Pinggang Sabah

    Kota Kinabalu, Sabah, 88100

  • Hospital Queen Elizabeth

    Kota Kinabalu, Sabah, 88586

  • SP Menon Dialysis Centre

    Kuala Lumpur, Kuala Lumpur, 50400

  • Pusat Hemodialisis, Yayasan Felda

    Kuala Lumpur, Kuala Lumpur, 54000

  • The Kidney Dialysis Centre

    Kuala Lumpur, Kuala Lumpur, 58100

  • Pantai Medical Centre, Kuala Lumpur

    Kuala Lumpur, Kuala Lumpur, 59100

  • Hospital Kuala Lumpur

    Kuala Lumpur, Kuala Lumpur

  • Tung Shin Hospital

    Kuala Lumpur, Kuala Lumpur

  • Hospital Kuala Terengganu

    Kuala Terengganu, Terengganu, 20400

  • Hospital Tengku Ampuan Afzan

    Kuantan, Pahang

  • Pahang Buddhist Association

    Kuantan, Pahang

  • Timberland Medical Centre

    Kuching, Sarawak, 93250

  • MAA Medicare Kidney Charity Dialysis Centre

    Kuching, Sarawak, 93540

  • Hospital Umum Sarawak

    Kuching, Sarawak, 93586

  • Hospital Melaka

    Malacca, Melaka, 75400

  • Haemodialysis Unit , Sunway Medical Centre

    Petaling Jaya, Selangor, 46150

  • SP Menon Dialysis Centre, Megah Medical Specialist Centre

    Petaling Jaya, Selangor

  • Pontian Rotary Haemodialysis Centre

    Pontian Besar, Johor, 82000

  • Penang General Hospital

    Pulau Pinang, Pulau Pinang, 10990

  • Pusat Hemodialisis Mawar (Seremban)

    Seremban, Negeri Sembilan, 70300

  • Seremban General Hospital

    Seremban, Negeri Sembilan, 70300

  • Hospital Taiping

    Taiping, Perak, 34000

Other trials in Malaysia

About this study

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.

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

Read the 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.

Being tested
GerEPO

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GerEPODrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 (2)

  1. • To compare GerEpo with Eprex® with respect to their respective frequency of adverse events

  2. To monitor the occurrence of PRCA and other immunogenicity related adverse events among patients on GerEpo observed for at least a year on therapy.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2005 (estimated)
  2. Study startApr 2005
  3. Study completionNov 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
270 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00229099
Sponsor's protocol ID
CT05-02
Status last verified
Dec 2005
First submitted
28 Sep 2005
Last updated
26 Oct 2006
Results posted
No

Publications

  • Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.

    PubMed 36791280

  • 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.

    PubMed 17803464

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GerEPO in people with Chronic Renal Failure Related Anemia, run by Ministry of Health, Malaysia at 32 sites in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00229099, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2006.

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