Renal failure patients with anaemia on chronic haemodialysis MedDRA version: 9.1 Level: LLT Classification code 10009120 Term: Chronic renal failure anaemia
Conditions
Interventions
Product Name: Epostim
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Erythropoietin alpha
CAS Number: 8000047076
Current Sponsor code: Epostim
Other descriptive name: ERYTHROPOIETIN
Sponsors
GeneMedix plc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients between the ages of 18 and 75 years inclusive 2. Patients with known renal disease with or without transplant 3. Patients with a therapeutic indication for treatment of anaemia after correction for iron, folate or B12 deficiency (transferrin saturation =20%, serum ferritin = 100 ug/l) 4. Patients with a haemoglobin level maintained in the range 10-12 g/dl for at least the preceding three months 5. Patients undergoing chronic haemodialysis (Kt/V > 1.1) and on a stable dose of Eprex®, for correction of anaemia, for a minimum of 3 months preceding study entry 6. Patients maintained on low flux dialysis, or on high flux but not switching membrane 7. Patients who have read the provided study information leaflet and understood the nature and purpose of the trial 8. Patients who have given written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Uncontrolled hypertension (BP >180/100) 2. Haemoglobin < 7 g/dl 3. Evidence of acute nephropathy evidenced by elevated CRP 4. Blood clotting abnormalities considered by the Investigator to put patients at risk and patients unable to receive antithrombotic prophylaxis 5. Allergy to mammalian cell derived products 6. Allergy to human serum albumin 7. Pregnant or lactating patients. (Women of childbearing potential must use an adequate method of contraception or sign a form agreeing abstinence) 8. Inclusion to any other clinical trial within previous 28 days 9. Patient deemed unsuitable for study inclusion based on Investigator decision made on clinical grounds
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate therapeutic comparability of Epostim with Eprex;Secondary Objective: To assess safety related aspects of repeat dosing with Epostim;Primary end point(s): The primary pharmacodynamic or therapeutic efficacy endpoint for this study will be the change in haemoglobin level from baseline to end of the double-blind treatment phase. The co-primary endpoint will be the dose of erythropoietin. ? Change in Hb (g/dl) ? Erythropoietin dose | — |
Countries
Lithuania
Outcome results
None listed