Comparison Among Erythropoietin Stimulating Agents

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hamad Medical Corporation
• Treatments: Darbepoetin alfa; Epoetin Alfa

Criteria

Inclusion Criteria:

• Aged ≥18 years

• have stable chronic renal anemia (with hemoglobin range of 10-12 g/dL) and on regular haemodialysis 3 x week with urea reduction ratio greater or equal to 65% or KT/V ( K - dialyzer clearance of urea, t - dialysis time, V - volume of distribution of urea, approximately equal to patient's total body water) greater or equal to 1.2.

• Patients must have received haemodialysis three times weekly for ≥12 weeks before screening and during the 4-week screening/baseline period.

• Eligible patients must have stable hemoglobin concentrations (stable is defined as ≤25% change in weekly dose of ESA over 8 weeks).

• Recruited patients must have undergone continuous maintenance intravenous conventional Epoetin alpha or beta therapy for ≥8 weeks before screening and during the screening/baseline.

• Patients should have adequate iron status, defined as serum ferritin ≥100 μg/L and transferrin saturation ≥20%.

Exclusion Criteria:

• New York Heart Association (NYHA) class III or IV congestive heart failure

• Uncontrolled hypertension (defined as pre-dialysis diastolic blood pressure

• 105 mmHg or systolic BP≥ 160 mmHg during the screening period)

• Evidence of uncontrolled hyperparathyroidism (defined as parathyroid hormone level >1000 pg/ml with no response to conventional treatment of hyperparathyroidism according to Kidney Disease Outcomes Quality Initiative (KDOQI) guide line during the 12 months prior to baseline)

• Treatment for grand mal epilepsy

• Haematological, inflammatory or infectious conditions that might interfere with the erythropoietin response

• Received red blood cell transfusions within 12 weeks before screening or during the screening/baseline period.

• reactive protein >30 mg/L

• The likelihood of early withdrawal; or life expectancy of <12 months

• Poor compliance with dialysis treatment, evidenced by >2 missed treatment monthly over the previous 3 months10. Refuse to be involved in the study.