Anaemia Correction in Haemodialyzed Patients - Comparative Analysis of Two Erythropoietin Stimulating Agents Schedules

• Status: Withdrawn
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Several recent reports support the efficacy of once every-other-week epoetinum administration in the maintenance phase of the anaemia treatment in predialysis, haemodialysis and in peritoneal dialysis CKD patients.

However, there are studies suggesting that in HD patients receiving SC short-acting ESA therapy, ESA efficacy decreases when the dosing is extended from thrice-weekly to once-weekly administration. When every-2-week administration of long-acting ESAs is extended to every 4 weeks, efficacy either remains stable or decreases incrementally. The GAIN trial (Gain effectiveness in Anemia treatment with NeoRecormon®) was designed to compare anemia management with epoetin beta, epoetin alpha or darbepoetin alpha in HD patients. An interim analysis of data from 1005 stable HD patients suggested that switching to epoetin beta from either epoetin alpha or darbepoetin alpha resulted in improved efficacy and a 20% dose reduction in SC epoetin beta.

The aim of the study is to compare two schedules of anaemia treatment in HD patients using two different erythropoietic stimulating agents (epoetinum beta vs darbepoetinum) with respect to the efficacy in anaemia correction and to the haemoglobin (Hb) level stability.

This is a multicenter (2 centers), prospective, open-label, parallel, controlled trial of therapy equivalence

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

Details

• Lead Sponsor: Anemia Working Group Romania
• Collaborators: Dr Carol Davila Teaching Hospital of Nephrology; Romanian Renal Registry
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• adult age (≥18 years)

• at least 6 months HD

• efficient HD (urea-equilibrated Kt/V >1.2, Daugirdas II equation)

• haemoglobin (Hb) levels above 10g/dL

• treatment with an ESA for at least 12 weeks prior to enrollment

• serum ferritin level 100-800 ng/mL

• transferrin saturation 20-50%.

Exclusion Criteria:

• hepatic diseases (as defined by abnormal ALT and AST levels) or association of psychical disorders or other disturbances making the enrollment unacceptable, as judged by the physician

• acute infection or HIV infection

• severe hyperparathyroidism (iPTH >800 ng/mL)

• active bleeding

• > 5% variation in dry body weight in the last 6 months

• previously diagnosed folic acid and/or vitamin B12 deficiency

• neoplastic diseases

• other known causes of anaemia

• known hypersensibility to one of the administered drugs

• epilepsy

• pregnancy or lactation

• anti-viral treatment during the month before the inclusion

• immunosuppressive treatment or use of other medication known to influence erythropoiesis during the month preceding the enrollment

• need for blood transfusions within 12 weeks prior to enrollment