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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02341547
Other study ID # CT14-HPP-003
Secondary ID
Status Not yet recruiting
Phase N/A
First received January 13, 2015
Last updated January 18, 2015
Start date February 2015
Est. completion date December 2015

Study information

Verified date January 2015
Source Penang Hospital, Malaysia
Contact Ong Loke Meng, FRCS
Phone 00 604 2225333
Email onglm@crc.gov.my
Is FDA regulated No
Health authority Malaysia: National Medical Research Register
Study type Observational

Clinical Trial 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


Description:

Anaemia in CKD is associated with reduced quality of life and increased cardiovascular disease, hospitalizations, cognitive impairment, and mortality. Correcting anaemia is considered an important part of slowing or even stopping the progression of CKD. Recombinant human erythropoietins (EPO) such as epoetin alfa are erythropoiesis-stimulating agents (ESAs) that are important treatment options. The ESA that is currently used in the hospital is Eprex®, a recombinant human EPO epoetin alfa which will soon be replaced by Binocrit®, a biosimilar ESA approved by the European Medicines Agency (EMA). We want to see whether maintenance of haemoglobin in stable ESRF patients would be affected by this switch in real life practice in the Malaysian population.

This is a prospective, observational, non-inferiority study in ESRF patients stable on Eprex who are switched to a Bio similar Epoetin Alfa .

Study population will be 44 End stage renal failure patients from Penang and Seberang Jaya hospital.Following recruitment, a baseline data collection of full routine laboratory test before switch to a Bio similar Epoetin Alfa .Primary endpoint is Mean change in haemoglobin levels at 6 weeks and Secondary endpoint is Mean change in haemoglobin levels at 12 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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 44
Est. completion date December 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group 12 Years and older
Eligibility Inclusion Criteria:

1. End Stage Renal Failure (ESRF) patients on 3x per week HD for at least 6 months who are planned for conversion to Binocrit

2. Stable dose of Eprex and iron for at least 3 months

3. No active bleeding

Exclusion Criteria:

1. Allergy to erythropoietin

2. Bone marrow disorder

3. Acute/chronic bleeding

4. Acute illness requiring hospitalization within the last 3 months

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Drug:
a Biosimilar Epoetin Alfa
End Stage Renal Failure patients stable on Eprex switched to Binocrit

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Penang Hospital, Malaysia

Outcome

Type Measure Description Time frame Safety issue
Primary Mean change in haemoglobin levels 12 weeks No
Secondary Adverse drug reactions and serious adverse effects It is a composite end point 12 weeks Yes
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