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

• Conditions: Chronic renal anemia; MedDRA version: 9.1Level: LLTClassification code 10058124Term: Nephrogenic anemia

• Registration Number: EUCTR2006-006349-15-GR
• Lead Sponsor: Roche (HELLAS) SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Written informed consent
- Age 18 years or older
- Chronic renal anaemia
- Haemoglobin concentration between 10.5 and 12.5 g/ dL
- Adequate iron status (serum ferritin > 100 ng/ mL AND TSAT > 20%) OR hypochromic red cells < 10%
- Continuous intravenous maintenance epoetin alpha or darvepoetin alpha therapy with the same dosing interval and the same EPO during the previous 3 months
- Regular long-term haemodialysis therapy with the same mode of dialysis for at least the previous 3 months
- 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

- Transfusion of red red blood cells during the previous 2months
- Poorly controlled hypertension, i.e. sitting blood pressure exceeding 170/100 despite medication requiring hospitalization or interruption of epoetin alfa or darvepoetin alfa treatment in the previous 6 months
- Significant acute or chronic bleeding such as overt gastrointestinal bleeding
- Active malignant disease (except non-melanoma skin cancer)
- Haemolysis
- Haemoglobinpathies (e.g. homozygous sickle- cell disease, thalassemia of all types)
- Folic acid deficiency
- Vitamin B12 deficiency
- Platelet count > 500 × 10[9]/ L or < 100 × 10[9]/ L
- Pure red cell aplasia
- Epileptic seizure during previous 6 months
- Congestive heart feilure (NYHA Class IV)
- Myocardial infraction or stroke, severe or unstable coronary artery diease, severe liver disease during the previous 3 months
- Uncontrolled or symptomatic secondary hyperparathyroidism
- Pregnancy or lactation period
- Women of childbearing potential without effective contraception
- Participation in a clinical trial or receipt of investigational compound or an investigational treatment during the previous 3 months
- Planned (date) elective surgery during the study period except for
- cataract surgery
- Known hypersensitivity to recombinant human erythropoetin, polyethylene glycol or to any constituent of the study medication
- Temporary (untunneled) dialysis access catheter

Study & Design

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