Bio-Equivalency of 2 Treatment Schedules in HD Patients Clinical Trial
— VAESOfficial title:
Anaemia Correction in Haemodialyzed Patients - Comparative Analysis of Two Erythropoietin Stimulating Agents Schedules
| Verified date | December 2017 |
| Source | Anemia Working Group Romania |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | March 2009 |
| Est. primary completion date | December 2008 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Romania | "Dr Carol Davila" Fresenius NephroCare Dialysis Centre | Bucharest | |
| Romania | IHS Dialysis Centre "Sf Ioan Nou" Clinical Hospital | Bucharest |
| Lead Sponsor | Collaborator |
|---|---|
| Anemia Working Group Romania | Dr Carol Davila Teaching Hospital of Nephrology, Romanian Renal Registry |
Romania,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | - hemoglobin level during the study and - monthly ESA dose per dry body weight during the study | 80 weeks of the study | ||
| Secondary | - percentage of patients maintaining target Hb without increase in ESA dose - difference between the average Hb during second study phase period versus the first one and versus baseline phase | during the study |