An single arm, open label, interventional multicenter study to assess the efficacy, safety and tolerability of once-monthly administration of intravenous C.E.R.A. for themaintenance of haemoglobin levels in hemodialysis patients with chronic renal anaemia - MIRACLE

• Conditions: chronic renal anemia

• Registration Number: EUCTR2007-001721-97-AT
• Lead Sponsor: Roche Pharma (Schweiz) AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Written informed consent
2. Age 18 years or older
3. Chronic renal anaemia
4. Haemoglobin concentration in the country specific target range (Switzerland: between 11 g/dL and 13 g/dL; Austria: between 10 g/dL and 12 g/dL)
5. Adequate iron status (serum ferritin >100 ng/mL AND TSAT>20% OR hypochromic red cells <10%)
6. Continuous intravenous or subcutaneous maintenance darbepoetin alfa, epoetin alfa or epoetin beta therapy with the same dosing interval (1-3 x weekly or 1 x 2-weekly) during the previous 2 months
7. Regular long-term haemodialysis therapy with the same mode of dialysis for at least the previous 3 months
8. Kt/V = 1.2 measured either by blood sampling or online monitoring at screening for haemodialysis patients (or URR =65%) and a minimum of three dialysis sessions per week
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

1. Transfusion of red blood cells during the previous 2 months
2. Poorly controlled hypertension at investigator’s discretion
3. Significant acute or chronic bleeding such as overt gastrointestinal bleeding
4. Active malignant disease (except non-melanoma skin cancer)
5. Haemolysis: haptoglobin <30 mg/dL (3.54 mmol/L) or other reliable positive test of haemolysis
6. Haemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types)
7. Folic acid deficiency
8. Vitamin B12 deficiency
9. Platelet count >500 x 109/L or <100 x 109/L
10. Pure red cell aplasia
11. Epileptic seizure during previous 6 months
12. Active infection or inflammation at investigator's discretion
13. Congestive heart failure (NYHA Class IV)
14. Myocardial infarction or stroke. Severe or unstable coronary artery disease, severe liver disease at investigator’s discretion during the previous 3 months
15. Uncontrolled or symptomatic secondary hyperparathyroidism at investigator’s discretion
16. Pregnancy or lactation period
17. Women of childbearing potential without effective contraception
18. Participation in a clinical trial or receipt of an investigational compound or an investigational treatment during the previous 3 months
19. Life expectancy <12 months
20. Planned (date) elective surgery during the study period except for
21. cataract surgery
22. Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
23. Temporary (untunneled) dialysis access catheter

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the long term maintenance of haemoglobin levels, with once-monthly intravenous administration of C.E.R.A. in hemodialysis patients with chronic renal anaemia.;Secondary Objective: - to evaluate the safety and tolerability of C.E.R.A. once-monthly in the treatment of anaemia in patients with chronic kidney disease<br><br>- to assess the fluctuation of individual haemoglobin levels.;Primary end point(s): The proportion of patients maintaining average haemoglobin concentration during the EEP within the in the country specific target range (for Switzerland between 11 g/dL and 13 g/dL and for Austria between 10 g/dL and 12 g/dL) OR +/- 1 g/dL of the reference haemoglobin concentration.