Efficacy Study of Two Formulations of Erythropoietin

NCT01184495 | Completed Phase 3 DMC

• 1 other identifier: 06-168
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

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

Keywords

Erythropoietin; Chronic renal failure; Hemodialysis; Anemia

Outcome Measures

Primary Outcomes (1)

• Hemoglobin Level in blood

  The evaluation of the efficacy between different formulations of recombinant EPO: the one produced by Bio-Manguinhos and produced by private industry was observed in response to EPO as measured by levels of hemoglobin (Hb) results. The mean Hb of the two groups were compared, as well as the variation observed in both groups over time follow-up (six months).

  Monthly assessment of the levels of hemoglobin in blood at baseline and monthly for six months

Secondary Outcomes (1)

• Safety

  Monthly assessment of adverse events

Study Arms (2)

Epoetin Bio-Manguinhos

EXPERIMENTAL

Drug: Epoetin Alfa-BioManguinhos

EPO-BioSimilar

ACTIVE COMPARATOR

Subcutaneous administration of EPO-BioSimilar

Drug: Epoetin Alfa-BioSimilar

Interventions

Epoetin Alfa-BioManguinhos DRUG

Subcutaneous administration of EPO-BioManguinhos

Epoetin Bio-Manguinhos

Epoetin Alfa-BioSimilar DRUG

Subcutaneous administration of EPO-BioSimilar

EPO-BioSimilar

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Rio Grande do Sul State Health Department - SES/RS: collaborator
• Oswaldo Cruz Foundation: collaborator

Related Publications (1)

• 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.

  PMID: 25141114 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Anemia

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Paulo Dornelles Picon

  Hospital de Clinicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MhD

Study Record Dates

• First Submitted: August 17, 2010
• First Posted: August 19, 2010
• Study Start: April 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: January 1, 2009
• Last Updated: February 27, 2017

Record last verified: 2017-02