Efficacy and Safety of subcutaneous administration of XM01 and Epoetin beta for treatment of anaemia in chronic renal failure patients not yet receiving dialysis. A multinational, multicentre, randomised, controlled, double-blind, parallel group phase II study.

• Conditions: treatment of anaemia in chronic renal failure patients not yet receiving dialysis; MedDRA version: 8.0Level: LLTClassification code 10054353

• Registration Number: EUCTR2005-000140-85-HU
• Lead Sponsor: BioGeneriX AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Patients of any ethnic origin meeting all criteria listed below will be included in the study:
1. Above 21 years of age (inclusive).
2. Male or female sex.
3. Patients with chronic renal failure not yet receiving dialysis and having a glomerular filtration rate (GFR) < 60 mL/min/1.73 m3 within the last 3 months (estimated by Cockroft-Gault formula)
4. Patients who have not been treated with epoetin within the last 12 weeks or with epoetins with a longer half-life time (e.g. Darbepoetin alfa, continuous erythropoiesis receptor activator [CERA]) within the last 6 months.
5. Stable haemoglobin (at least three measurements within the last 8 weeks prior to randomisation, the difference between the highest and lowest value should be less than 2 g/dL).
6. Haemoglobin = 10.0 g/dL (mean value of three measurements within the last 8 weeks, separated from each other by at least one week).
7. Serum ferritin >100 mg/L and transferrin saturation (TSAT) >20% (within the last 4 weeks prior to randomisation).
8. Patients who are able to understand and follow instructions and who are able to participate in the study for the entire period.
9. Written informed consent to participate in the study after receiving adequate previous information.
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

Patients presenting with any of the following will not be included in the study:
1. Female patients of childbearing potential.
2. Patients requiring red blood cell transfusions.
3. Red blood cell transfusion within the last 8 weeks.
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 6 months prior to enrolment.
6. Congestive heart failure (New York Heart Association [NYHA] class 3 or 4).
7. Uncontrolled diabetes mellitus defined as HbA1c >8.0%.
8. 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).
9. Severe metabolic acidosis (bicarbonate <18 mEq/L [<18 mmol/L]).
10. Tertiary or poorly controlled secondary hyperparathyroidism defined as intact parathyroid hormone (PTH) = 10 times the ULN.
11. Severe endogenous depression or schizophrenia.
12. Current malignant disease.
13. Known bone marrow disease.
14. Current systemic infection or inflammatory disease.
15. Any cause for anaemia other than chronic renal failure.
16. Deficiency of vitamin B12 and/or folic acid (i.e. below lower limit of reference range)
17. Known to test positive for human immunodeficiency virus antibodies.
18. Concomitant therapy with immunosuppressive drugs or androgens or steroids (oral or intravenous).
19. Therapy with androgens within the last 3 months.
20. Patients with known hypersensitivity (drug intolerance or allergy) to Epoetin or excipients of the formulation.
21. Known presence of antibodies to Epoetin.
22. Known or suspected drug abuse or alcohol abuse.
23. Participation in a study with investigational drugs within 30 days prior to enrolment.
24. Planned travel activities outside the participating countries during the study.
Patients may be enrolled into this study more than once only in case the inclusion criteria Nos. 5, 6 or 7 are not fulfilled or the exclusion criterion No. 16 is fulfilled during the screening period.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified