Effectiveness of a Biosimilar Epoetin Alfa in Stable 'End Stage Renal Failure'

NCT02341547 | Unknown

• 1 other identifier: CT14-HPP-003
• Study Type: observational
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective, observational, non-inferior study in ESRF patients stable on Eprex who are switched to a Biosimilar Epoetin Alfa. Study plans to recrut 44 patients. Following recruitment, a baseline data collection of full routine laboratory test before switch to Binocrit.Primary endpoint is Mean change in haemoglobin levels at 12 weeks and Secondary endpoint is Mean change in haemoglobin levels at 6 weeks Safety endpoint will be Adverse drug reactions and serious adverse effects Analysis: Changes from baseline at Week 6 and Week 12 will be evaluated using paired t-test or Wilcoxon signed ranks test as appropriate. Changes in continuous variables over time were evaluated using repeated-measures analysis of variance. Patients with iron-deficiency (ferritin \<100 ng/ml or transferrin saturation \<20%) will be analysed separately

Conditions

End Stage Renal Failure; Anaemia

Outcome Measures

Primary Outcomes (1)

• Mean change in haemoglobin levels

  12 weeks

Secondary Outcomes (1)

• Adverse drug reactions and serious adverse effects

  12 weeks

Interventions

a Biosimilar Epoetin Alfa DRUG

End Stage Renal Failure patients stable on Eprex switched to Binocrit

Also known as: Binocrit

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

End Stage Renal Failure (ESRF) patients stable on Eprex who are switched over to Binocrit

You may qualify if:

• End Stage Renal Failure (ESRF) patients on 3x per week HD for at least 6 months who are planned for conversion to Binocrit
• Stable dose of Eprex and iron for at least 3 months
• No active bleeding

You may not qualify if:

• Allergy to erythropoietin
• Bone marrow disorder
• Acute/chronic bleeding
• Acute illness requiring hospitalization within the last 3 months

Sponsors & Collaborators

• Penang Hospital, Malaysia: lead

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Anemia

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Ong Loke Meng, FRCS

  Penang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ong Loke Meng, FRCS

CONTACT

00 604 2225333; onglm@crc.gov.my

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Nephrologist and Head of Medical Department

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: January 19, 2015
• Study Start: February 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 21, 2015

Record last verified: 2015-01