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

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

• Registration Number: EUCTR2008-003173-40-IT
• Lead Sponsor: ROCHE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08-01
• 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 10.0 g/dl and 12.0 g/dl
Adequate iron status (serum ferritin >100 ng/mL AND TSAT>20% OR hypochromic red cells <10%)
Continuous subcutaneous maintenance darbopoetin alfa therapy with the same dosing interval during the previous month and no change in total (calculated) weekly dose.
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 blood cells during the previous 2 months
Poorly controlled hypertension, i.e. sitting blood pressure exceeding 170/100 despite medication requiring hospitalization or interruption of darbopoetin 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
Haemoglobinopathies (e.g homozygous sickle-cell disease, thalassemia of all types)
Folic acid deficiency
Vitamin B12 deficiency
Platelet count >500 x 109/L or <100 x 109/L
Pure red cell aplasia
Epileptic seizure during previous 6 months
Congestive heart failure (NYHA Class IV)
Myocardial infarction or stroke, severe or unstable coronary artery disease, 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 an investigational compound or an investigational treatment during the previous 3 months
Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
Planned (date) elective surgery during the study period except for
cataract surgery
vascular access surgery

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 subcutaneous administration of C.E.R.A. in pre-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 average haemoglobin concentration during the EEP within the target range