Efficacy Study of Two Formulations of Erythropoietin

NCT ID: NCT01184495

Last Updated: 2017-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2009-01-31

Brief Summary

A double-blind, randomized trial aimed to compare the efficacy of two formulations of erythropoietin in patients with chronic renal failure on hemodialysis

Conditions

Comparison of the Efficacy of Two Formulations of Epoetin in Patients Undergoing Hemodialysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Epoetin Bio-Manguinhos

Group Type: EXPERIMENTAL

Epoetin Alfa-BioManguinhos

Intervention Type: DRUG

Subcutaneous administration of EPO-BioManguinhos

EPO-BioSimilar

Subcutaneous administration of EPO-BioSimilar

Group Type: ACTIVE_COMPARATOR

Epoetin Alfa-BioSimilar

Intervention Type: DRUG

Subcutaneous administration of EPO-BioSimilar

Interventions

Epoetin Alfa-BioManguinhos

Subcutaneous administration of EPO-BioManguinhos

Intervention Type: DRUG

Epoetin Alfa-BioSimilar

Subcutaneous administration of EPO-BioSimilar

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• We included adult patients with chronic renal failure on hemodialysis for more than three months at the Dialysis Unit of the Department of Nephrology, HCPA and the Center for Dialysis and Transplant (CDT), characterized as as patients on chronic regular dialysis procedure. Patients already in use of EPO for at least three months, only those taking the drug by subcutaneous and agreed to participate in the study.

Patients using different doses of EPO were included, but these were distributed across the treatment groups by randomization stratum dose of EPO, to ensure even distribution of patients in both groups.

It was considered that patients with HIV or AIDS who were in treatment for the disease with proper clinical management would be eligible for the study (as exemplified by patients with HIV or AIDS approved for inclusion on the waiting list for cadaveric kidney transplantation) .

Patients with a history of cancer or already treated in the oncological standpoint, and no signs of disease activity could be included.

Exclusion Criteria

• Patients who had other causes of anemia defined for maintenance, for example, patients with liver cirrhosis, with a history of gastrointestinal bleeding, patients with chronic Gastro Intestinal, Genital or Urinary bleeding or other sites were excluded. Similarly patients with AIDS without treatment, hemolytic anemia, pancytopenia, thalassemia, sickle cell anemia, myelodysplasia, multiple myeloma or other cancers or inflammatory arthritis. There was also no inclusion of patients with intolerance or allergy to iron parenterally, patients without adherence to dialysis or with chronic inadequate dialysis blood flow of vascular access persistently below 250 mL / min, kt / v, as a measure of efficiency of hemodialysis, persistently <1.2) or frequent hospitalizations considered as possible causes of inadequate response to erythropoietin.

We excluded patients with mental illness or condition that prevents the free consent and signature of informed consent, as well as previous reports of serious adverse effects to the drugs studied.

Criteria for withdrawal from the clinical trial: a view of the high morbidity of hemodialysis patients, expressed by frequent hospital clinics, it was found that patients in the study would not be withdrawn from the study due to hospitalization, provided that: the hospital did not involve surgery (except vascular access surgery or hospitalization in the intensive care unit or equivalent, or that represent otherwise, a loss of patient follow-up or co-interventions in the treatment of anemia of these).

Were withdrawn from the study patients who required blood transfusion because they have severe anemia or intervention unrelated to the usual treatment of anemia in hemodialysis patients.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rio Grande do Sul State Health Department - SES/RS

OTHER_GOV

Sponsor Role: collaborator

Oswaldo Cruz Foundation

OTHER

Sponsor Role: collaborator

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Paulo Dornelles Picon

MhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paulo Dornelles Picon

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clinicas de Porto Alegre

References

Picon PD, Pribbernow SC, Prompt CA, Schacher SC, Antunes VV, Mentz BP, Oliveira FL, Souza CM, Schacher FC. Randomized double-blind clinical trial of a new human epoetin versus a commercially available formula for anemia control in patients on hemodialysis. Clinics (Sao Paulo). 2014 Aug;69(8):547-53. doi: 10.6061/clinics/2014(08)08.

Reference Type: DERIVED

PMID: 25141114 (View on PubMed)

Other Identifiers

06-168

Identifier Type: -

Identifier Source: org_study_id