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 haemodialysis patients with chronic renal anaemia

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

• Registration Number: EUCTR2007-003679-37-DK
• Lead Sponsor: Roche a/s

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-31
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

Inclusion Criteria:
•Written informed consent
•Age 18 years or older
•Chronic renal anaemia
•Haemoglobin concentration between 10.5 g/dl and 12.5 g/dl
•Adequate iron status (serum ferritin >100 ng/mL AND TSAT>20% OR
hypochromic red cells <10%)
•Continuous intravenous maintenance darbepoetin alfa or epoetin alfa
therapy with unchanged dosing interval during the previous 2 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

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
darbepoetin 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 call 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
•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