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.
- Conditions
- anaemic chronic renal failure patients not yet receiving dialysisMedDRA version: 9Level: LLTClassification code 10009119
- Registration Number
- EUCTR2005-000142-37-HU
- Lead Sponsor
- BioGeneriX AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 255
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.
10. Signed and dated 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
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.
10. Severe endogenous depression or schizophrenia.
11. Current malignant disease.
12. Current systemic infection or inflammatory disease.
13. Known positive test for human immunodeficiency virus (HIV) antibodies.
14. Concomitant therapy with immunosuppressive drugs, steroids (oral or intravenous) or androgens.
15. Therapy with androgens within the last 3 months prior to enrolment.
16. Patients with resistance to Epoetin (more than 300 IU/kg/week).
17. Patients who have been treated with Epoetins with a longer half life time (e.g. novel erythropoiesis stimulating protein [NESP], continuous erythropoietin receptor activator [CERA]) within the last 6 months.
18. Known hypersensitivity (drug intolerance or allergy) to Epoetin or excipients of the formulation.
19. Known presence of antibodies to Epoetin.
20. Known or suspected drug abuse or alcohol abuse.
21. Participation in a study with investigational drugs within 30 days prior to enrolment.
22. Planned travel activities outside the participating countries during the study.
Under no circumstances may patients be enrolled into this study more than once.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method