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

NCT00551603 | Withdrawn Phase 4

• 2 other identifiers: AWG_03_071246/ANM
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Bio-Equivalency of 2 Treatment Schedules in HD Patients

Keywords

epoetinum beta once-weekly; darbepoetinum once-fortnightly; anemia correction; hemoglobin stability

Outcome Measures

Primary Outcomes (1)

• - hemoglobin level during the study and - monthly ESA dose per dry body weight during the study

  80 weeks of the study

Secondary Outcomes (1)

• - 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

Study Arms (2)

1

EXPERIMENTAL

Group Epo will receive anaemia treatment according to the Romanian Best Practice Guidelines recommendation, with once-weekly SC epoetinum beta during the first phase, then will be switched to receive SC once-fortnightly darbepoetinum. Anaemia treatment schedule will continue according to the Romanian Best Practice Guidelines recommendations, with the same dose. A conversion factor of 1:200 will be used.

Drug: switch (epoetinum beta, darbepoetinum)

2

ACTIVE COMPARATOR

Subjects in the Darbepo Group will receive anaemia treatment according to the Romanian Best Practice Guidelines recommendation, with once-fortnightly or once-monthly darbepoetin SC administration, continuing their previous schedule and will continue their previous schedule of anaemia treatment during the second phase of the study

Drug: continuation (darbepoetinum)

Interventions

switch (epoetinum beta, darbepoetinum) DRUG

switching from epoetinum beta once weekly to once-fortnightly darbepoetinum

Also known as: Group Epo

1

continuation (darbepoetinum) DRUG

continuation of the previous darbepoetinum administration schedule

Also known as: Darbepo Group

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Anemia Working Group Romania: lead
• Dr Carol Davila Teaching Hospital of Nephrology: collaborator
• Romanian Renal Registry: collaborator

Study Sites (2)

"Dr Carol Davila" Fresenius NephroCare Dialysis Centre

Bucharest, 0107231, Romania

Location

IHS Dialysis Centre "Sf Ioan Nou" Clinical Hospital

Bucharest, Romania

Location

Related Publications (1)

• Rath T, Mactier RA, Weinreich T, Scherhag AW; GAIN Investigators. Effectiveness and safety of recombinant human erythropoietin beta in maintaining common haemoglobin targets in routine clinical practice in Europe: the GAIN study. Curr Med Res Opin. 2009 Apr;25(4):961-70. doi: 10.1185/03007990902784459.

  PMID: 19254204 DERIVED

Study Officials

• Liliana Garneata, MD, PhD

  Anemia Working Group

  STUDY DIRECTOR

• Gabriel Mircescu, Professor

  Anemia Working Group

  STUDY CHAIR

• Carmen Barbulescu, MD

  "Dr Carol Davila" NephroCare Dialysis Centre

  PRINCIPAL INVESTIGATOR

• Alexandru Ciocalteu, Professor

  "IHS" Dialysis Centre "Sf Ioan Nou" Clinical Hospital

  STUDY DIRECTOR

• Daniela Ciortea, MD, PhD

  IHS Dialysis Centre, "Sf Ioan Nou" Clinical Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2007
• First Posted: October 31, 2007
• Study Start: July 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: March 1, 2009
• Last Updated: December 22, 2017

Record last verified: 2017-12

Locations

RO (2)