Efficacy and Safety of subcutaneous administration of XM01 compared to Epoetin beta in anaemic chronic renal failure patients not yet receiving dialysis and in maintenance phase treatment with Epoetin beta. A multinational, multicentre, randomised, controlled, double-blind, comparative, parallel group Phase III study.

BioGeneriX AG0 sites255 target enrollmentApril 12, 2005

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: anaemic chronic renal failure patients not yet receiving dialysis
Sponsor: BioGeneriX AG
Enrollment: 255
Status: Active, not recruiting
Last Updated: 14 years ago

No summary available.

Registry

who.int

Start Date

April 12, 2005

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Patients of any ethnic origin meeting all criteria listed below will be included in the study:
•1\. Patients being treated for known renal anaemia, on maintenance treatment with Epoetin beta.
•2\. Aged \=18 years.
•3\. Male or female.
•4\. Patients with chronic renal failure not yet receiving dialysis and having a glomerular filtration rate (GFR) \< 60 mL/min/1\.73 m2 within the last three months (estimated by Cockroft\-Gault formula).
•5\. Patients should be on maintenance treatment with once, two or three times weekly s.c. administration of Epoetin beta for at least 3 months prior to enrolment.
•6\. Patients should be on stable therapy with Epoetin which refers to a stable haemoglobin level defined as: at least four measurements within the last eight weeks with the difference between the highest and lowest value of less than 2 g/dL. There should be at least 1 week between each of the four haemoglobin measurements.
•7\. Haemoglobin concentration \= 9\.5 g/dL and \<12\.0 g/dL within the last eight weeks (mean value of four measurements, separated from each other by at least a week).
•8\. Serum ferritin \>100 µg/L or TSAT \>20% (within the last four weeks prior to enrolment).
•9\. Able to understand and follow instructions and able to participate in the study for the entire period.

•Patients presenting at Visit 1 with any of the following will not be included in the study:
•1\. Female patients of childbearing potential.
•2\. Patients with active bleeding.
•3\. Red blood cell transfusion within the last three months.
•4\. Uncontrolled severe hypertension defined as systolic blood pressure \>180 mmHg and/or diastolic blood pressure \>110 mmHg
•5\. History of myocardial infarction, cerebrovascular accident, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft within the six months prior to enrolment.
•6\. Congestive heart failure (New York Heart Association \[NYHA]13 class III or IV).
•7\. Patients with known liver disease or elevated serum transaminase (aspartate aminotransferase \[AST] or alanine aminotransferase \[ALT]) greater than twice the upper limit of normal (ULN) (Comment: Hepatitis B\-virus surface antigen (HBsAg) carrier status or positive antibodies to hepatitis C virus (HCV) per se is not defined as an exclusion criterion if transaminases are within the normal range).
•8\. Severe metabolic acidosis (bicarbonate \<18 mEq/L \[18 mmol/L]).
•9\. Tertiary or poorly controlled secondary hyperparathyroidism defined as intact parathyroid hormone (PTH) \= 10 times the ULN.