NCT00322413

Brief Summary

The two epoetins, Epoetin alfa, a well established drug to treat renal anemia and Epoetin Omega, that differs from Epoetin alfa in the sugar moiety of the molecule were compared in regard of efficacy and safety to treat end stage renal disease anemia. Study hypothesis was that Epoetin Omega is non-inferior to Epoetin alfa in correcting renal anemia in dialysis patients. A 12-weeks randomized comparative efficacy study was performed including 77 end stage renal disease patients (epoetin omega:n=39, epoetin alfa: n=38). In the intent-to-treat analysis, average weekly difference in hemoglobin versus baseline value was higher in omega-treated patients: 1.94+-0.81 vs. 1.23+-0.62 g/dl. The unadjusted and adjusted omega-alfa differences were 0.71 g/dl (95%CI 0.38 to 1.04; p\<0.001) and 0.78 g/dl (0.49 to 1.08;p\<0.001), respectively. Average weekly epoetin dose was lower in the omega group: 87+-25 vs. 108+-21 IU/kg. The unadjusted and adjusted omega-alfa differences were -21IU/kg (-32 to -11; p\<0.001) and -24IU/kg (-35 to -13; p\<0.001), respectively. Epoetins were comparably well tolerated. In dialysis patients, subcutaneous epoetin omega apparently provides a greater anti-anemic effect per administered dose (IU) than epoetin alfa.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 1997

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1997

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 1997

Completed
9.1 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 5, 2006

Completed
Last Updated

July 21, 2006

Status Verified

May 1, 2006

First QC Date

May 4, 2006

Last Update Submit

July 20, 2006

Conditions

End Stage Renal DiseaseRenal AnemiaRegular Dialysis Treatment

Keywords

Epoetin alfaEpoetin omegaComparative efficacy trialRenal anemia

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin level

Secondary Outcomes (2)

  • Average weekly epoetin dose

  • Time to achieve hemoglobin level of 10 g/dl

Interventions

EpoetinDRUG

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • End stage renal disease
  • Regular dialysis treatment
  • Renal anemia (hemoglobin\<9.0 g/dl)
  • Age \> 18 years
  • Adequate iron stores (TIBC saturation \> 20%, ferritin \>200)

You may not qualify if:

  • Signs of bleeding
  • Major surgery in previous 60 days
  • Hemolysis
  • Other causes of anemia
  • Cancer
  • Inflammatory diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nephrology and Dialysis, General Hospital Sveti Duh

Zagreb, 10000, Croatia

Location

Related Publications (2)

  • Milutinovic S, Trkulja V. Reduced responsiveness to epoetin at re-exposure after prolonged epoetin-free period in anemic hemodialysis patients with end-stage renal disease. Croat Med J. 2006 Jun;47(3):424-32.

    PMID: 16758521RESULT

  • Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.

    PMID: 36791280DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Erythropoietin

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Slobodan Milutinovic, M.D., Ph.D.

    Department of Nephrology and Dialysis, General Hospital Sveti Duh, Zagreb, Croatia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 4, 2006

First Posted

May 5, 2006

Study Start

January 1, 1997

Study Completion

April 1, 1997

Last Updated

July 21, 2006

Record last verified: 2006-05

Locations

CR(1)