A randomized, controlled, open-label, multi-centre, parallel-group study to assess all-cause mortality and cardiovascular morbidity in patients with chronic kidney disease on dialysis and those not on renal replacement therapy under treatment with MIRCERA or reference ESAs. - ND
- Conditions
- Chronic renal anemiaMedDRA version: 9.1Level: PTClassification code 10058116Term: Nephrogenic anaemia
- Registration Number
- EUCTR2007-005129-31-IT
- Lead Sponsor
- ROCHE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2800
1. Written informed consent 2. Adult patients (>= 18 years old) with symptomatic anemia associated with CKD (renal anemia) 3. Patients with renal anemia who are not treated with an ESA: ? Anemia defined as Hb concentration < 11.0 g/dL (mean of 2 screening values with at least one day and a maximum 2 weeks between measurements) with a clinical indication for ESA treatment or 3. Patients with renal anemia who are on maintenance ESA therapy: ? If on dialysis: regular long-term hemodialysis or peritoneal dialysis therapy with the same mode of dialysis for at least 3 months before screening ? Continuous iv or sc maintenance ESA therapy: darbepoetin alfa (Aranesp, Nespo, Aranest), epoetin alfa (Eprex, Epogen, Epopen, Erypo) or epoetin beta (NeoRecormon, Recormon) administered according to approved label of the same agent and route of administration for at least 2 months before screening ? Hb concentration between 10 and 12 g/dL (mean of 2 screening values with at least one day and a maximum of 2 weeks between measurements) 4. Patients with adequate iron status defined as: serum ferritin above or equal to 100 μg/L or transferrin saturation above or equal to 20% (See section 4.4 of the SmPC).
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
Contraindications to ESA treatment (See Section 4.3 of SmPC): 1. Uncontrolled hypertension 2. Hypersensitivity to the active substance or any of the excipients of MIRCERA and other ESAs 3. Any other contraindication to ESA therapy Conditions known to cause inadequate response to ESA treatment or anemia other than symptomatic anemia associated with CKD, including (See Section 4.4. of the SmPC): 4. Hemoglobinopathies (e.g., homozygous sickle-cell disease, thalassemia of all types) 5. Anemia due to hemolysis 6. Pure red cell aplasia (PRCA) Other 7. High likelihood of early withdrawal (e.g. within 1 year) or interruption of the study 8. Pregnancy or breast-feeding 9. Women of childbearing potential without effective contraception 10. Administration of another investigational drug within 1 month before screening or planned during the study period
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to demonstrate non-inferiority of MIRCERA versus reference ESAs in terms of a composite endpoint of all-cause mortality and non-fatal cardiovascular events (myocardial infarction (MI), stroke).;Secondary Objective: To assess the incidence of anti-erythropoietin antibody-mediated pure red cell aplasia (PRCA), gastrointestinal bleeding and thromboembolic events.;Primary end point(s): Time to composite of all-cause mortality and non-fatal cardiovascular events (MI, stroke).
- Secondary Outcome Measures
Name Time Method