Darbepoetin (synthetic version of erythropoietin) vs erythropoietin to stimulate red blood cell production in dialysis patients

A randomized, open-label trial to establish the therapeutic equivalence between Darbepoetin Alpha and Erythropoietin Beta or Alpha in patients on dialysis.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN96020335

Enrollment

236

Registered

2023-11-22

Start date

2016-07-03

Completion date

Unknown

Last updated

2023-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anaemia in dialysis patients Haematological Disorders

Interventions

Patients on regular dialysis are randomized to darbepoetin or erythropoietin group and monitored for a treatment period of 20 weeks. The investigator will randomise the patient by usi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Written informed consent obtained. 2. Patients aged between 18 and 80 years. 3. Patients who are medically stable on dialysis for a minimum of 3 months. 4. Patients on erythropoietin treatment for ESKD related anemia and maintaining Hb level at or above 9 g/dL while on a stable dose (no change in dose) of erythropoietin within 6 weeks prior to the screening phase of this study.

Exclusion criteria

Exclusion criteria: 1. Pregnant or nursing women, 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. History of seizure disorder. 5. Active acute or chronic infection or inflammatory disease. 6. Any illness that required hospitalization within the last one month. 7. Any medical or social reasons which in the investigator’s judgment may interfere with patient’s ability to participate in the study, or interfere with the study assessments or interpretation of the results.

Design outcomes

Primary

Measure	Time frame
Hb levels measured using blood sample at screening and baseline (day 0), randomization (week 2), week 6, week 10, week 14, week 18, and follow up end of study (week 22)	—

Secondary

Measure	Time frame
Safety parameters (vital signs, adverse events, and laboratory values) measured using patient records throughout the study	—

Countries

Malaysia

Contacts

Public ContactBak Leong;Kim Liong Goh;Ang

;

drgohbakleong@moh.gov.my;angkl@crc.gov.my+60 389475467;+60 389475467

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026