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. - Post Authorization Safety Study (PASS)
- Conditions
- To gain more experience with MIRCERA administered under clinical practice conditions and according to the approved label by performing a non-inferiority study comparing MIRCERA to other ESAs in terms of cardiovascular morbidity and mortality.MedDRA version: 9.1Level: PTClassification code 10058116Term: Nephrogenic anaemia
- Registration Number
- EUCTR2007-005129-31-GR
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- 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 anaemia associated with CKD (renal anaemia)
3. Patients with renal anaemia who are not treated with an ESA:
– Anaemia defined as Hb concentration < 11.0 g/dL (mean of 2 screening values with at least one day between measurements)
or
3. Patients with renal anaemia who are on maintenance ESA therapy:
– If on dialysis: regular long-term 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 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 anaemia other than symptomatic anaemia associated with CKD, including (See Section 4.4. of the SmPC):
4. Hemoglobinopathies (e.g., homozygous sickle-cell disease, thalassemia of all types)
5. Anaemia 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): The primary objective is to demonstrate non-inferiority of MIRCERA® versus reference ESAs in terms of a composite endpoint of all-cause mortality and non-fatal cardiovascular events (MI, stroke), based on a non-inferiority limit of 1.20 for the hazard-ratio of the composite endpoint and a one-sided significance level of 0.025. The model used for the non-inferiority analyses will be a Cox model on time to event with treatment as the independent variable but no co-variables included in the model. The analysis will be based on the all-randomized population according to the original treatment assignment.
- Secondary Outcome Measures
Name Time Method