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

Roche (HELLAS) SA0 个研究点开始时间: 2007年6月28日最近更新: 2012年3月19日

研究概览

暂无简介。

•- 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

•- 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

发起方

Roche (HELLAS) SA