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Comparison Among Erythropoietin Stimulating Agents

NCT02049346 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 327

Last updated 2017-09-13

No results posted yet for this study

Summary

\* Background: Despite extensive use, to the best of our knowledge, no trial has simultaneously compared the three currently used erythropoietin stimulating agents (ESAs) in a prospective manner, in treatment of anemia of end stage renal disease (ESRD) patients.

\* Patients and Methods: All haemodialysis patients in Qatar who were treated with short acting Epoetin alfa or beta were screened. Eligible patients were randomized, either to continue on the previous regimen of Epoetin, or to receive Darbepoetin alfa or continuous erythropoietin receptor activator (C.E.R.A) for a total period of 40 weeks. All groups were assessed at the end of the study for safety and efficacy parameters.

Conditions

  • Anemia of End Stage Renal Disease

Interventions

DRUG

Epoetin alpha or beta (Epoetin group)

Erythropoetin doses in that were adjusted according to the approved prescribing information, without additional restrictions. Doses of erythropoetin were decreased by 25% for Hb values \>12 and ≤13 g/dL and increased by 25% for Hb \<11 and ≥10 g/dL. erythropoetin doses were increased by 50% for Hb \<10 g/dL. Treatment was interrupted temporarily if Hb exceeds 13 g/dL. The doses for all patients were adjusted so that haemoglobin concentrations were maintained within a target range of 11-12 g/dL during the study.

DRUG

Darbepoetin alfa

Subjects in that group received Darbepoetin alfa once every week or every 2 weeks as per protocol. Doses of Darbepoetin alfa were decreased by 25% for Hb values \>12 and ≤13 g/dL and increased by 25% for Hb \<11 and ≥10 g/dL. Darbepoetin alfa doses and increased by 50% for Hb \<10 g/dL. Treatment was interrupted temporarily if Hb exceeds 13 g/dL. The doses were adjusted so that haemoglobin concentrations were remain within a target range of 11-12 g/dL during the study. If a dose of Epoetin alpha/ beta does not equate exactly to a unit dose of Darbepoetin alfa at switching, then the nearest available unit dose of Darbepoetin alfa was used.

DRUG

Methoxy polyethylene glycol-epoetin beta

Patients in that arm received Intravenous MIRCERA monthly. The initial dose was 120 mcg, 200 mcg or 360 mcg, for patients had previously received a weekly dose of Epoetin alpha/ beta of less than 8000 IU, between 8000 to16 000 IU or more than16000IU respectively. MIRCERA doses were adjusted according to the approved prescribing information, without additional restrictions. Doses of MIRCERA were decreased by 25% for Hb values \>12 and ≤13 g/dL and increased by 25% for Hb \<11 and ≥10 g/dL. MIRCERA doses were increased by 50% for Hb \<10 g/dL. Treatment was interrupted temporarily if Hb exceeds 13 g/dL. The doses of MIRCERA were adjusted so that haemoglobin concentrations were maintained within a target range of 11-12 g/dL during the study.

Sponsors & Collaborators

  • Hamad Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Fadwa S. AL-Ali, MD · Hamad Medical Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-04-30
Completion
2013-06-30

Countries

  • Qatar

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02049346 on ClinicalTrials.gov