A single arm open label study to assess the efficacy, safety and tolerability and of once-monthly administration of intravenous C.E.R.A. for the maintanance of haemoglobin levels in dialysis patients with chronic renal anaemia. - STABI

• Conditions: Chronic renal anaemia; MedDRA version: 9.1Level: LLTClassification code 10058123Term: Renal anaemia

• Registration Number: EUCTR2007-002380-27-CZ
• Lead Sponsor: Roche s.r.o.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-03
• 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 and older
3. Chronic renal anaemia
4. Haemoglobin concentration between 10.5g/dl and 12.5g/dl
5. Adequite iron status (serum ferritin > 100ng/ml AND TSAT > 20% OR hypochromic red cells < 10%)
6. Continuous intracenous maintenence epoetin (epoetin alfy, epoetin beta or darbopoetin alfa) therapy with the same dosing interval during the previous two months
7. Regular long-term haemodialysis therapy with the same mode of dialysis for at least the previous 3 months
8. Kt/V > 1.0 at screening for haemodialysis patients (or URR > 55%)
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, i.e. sitting blood pressure exceeding 170/100 despite medication requiring hospitalization or interruption of epoetin (epoetin alfa, epoetin beta or darbopoetin alfa) treatment in the previous 6 months
3. Significant acute or chronic bleeding such as overt gastrointestinal bleeding
4. Active malignant disease (except non-melanoma skin cancer)
5. 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 x10 9/l or < 100x 10 9/l
10. Pure red cell aplasia
11. Epileptic seizure during previous 6 months
12. Congestive heart failure (NYHA Class IV)
13. Myocardial infarction or stroke, severe or unstable coronary artery disease, severe liver disease during the previous 3 months
14. Uncontrolled or symptomatic secondary hyperparathyroidism
15. Pregnancy or lactation period
16. Women of childbearing potential without effective contraception
17. Participation in a clinical trial or receipt of an investigational compound or an investigational treatment during the previous 3 months
18. Known hypersensitivity to recobinant human erathropoietin, polyethylene glycol or to any constituent of the study medication
19. Planned (date) elective surgery during the study period except for
- cataract surgery
- 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 dialysis 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;Primary end point(s): The proportion of patients maintaining avetrage haemoglobin concentration during the EEP within the target range.<br><br>