A Study of All-Cause Mortality and Cardiovascular Morbidity in CKD Patients on Dialysis and Those Not on Renal Replacement Therapy Receiving Mircera or Reference ESAs.
- 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: 14.1 Level: PT Classification code 10058116 Term: Nephrogenic anaemia System Organ Class: 10005329 - Blood and lymphatic system disordersTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2007-005129-31-GB
- Lead Sponsor
- F.Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 2825
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 1680
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1120
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
- Secondary Outcome Measures
Name Time Method