post renal transplant anaemia patients. MedDRA version: 9.1 Level: PT Classification code 10058116 Term: Nephrogenic anaemia
Conditions
Interventions
Trade Name: MIRCERA®
Product Code: RO0503821/F03
Pharmaceutical Form: Solution for injection
INN or Proposed INN: methoxy polyethylene glycol-epoetin beta
Current Sponsor code: RO0503821
Concentration
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent • Age 18 years or older • Renal transplant =6 months and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Requirement for haemodialysis or peritoneal dialysis therapy within 3 months prior to randomization • Change in haemoglobin concentration = 1.5 g/dL during the screening period (week -4 and -2) • Change in GFR >30% during the screening period Treatment for clinical acute rejection during screening period with GFR stability below 30% • Recipients of other solid organs in addition to kidneys • Patients planned to be switched from one immunosuppressive agent to another during study participation • History of positive Anti-phospholipid antibodies • Transfusion of red blood cells during the 3 months prior to randomization • Poorly controlled hypertension as judged by the investigator, OR requiring more than 3 antihypertensive drugs (excluding diuretics) • Significant acute or chronic bleeding, such as overt gastrointestinal bleeding, i.e. requiring therapy within 3 months prior to randomization • 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 10 exp9/L or <100 x 10 exp9/L • Pure red cell aplasia • Epileptic seizure in the 6 months prior to randomization • Congestive heart failure (NYHA Class IV) • Myelofibrosis • Active systemic lupus erythematosus • Myocardial infarction or stroke, severe or unstable coronary artery disease, severe liver disease during the 3 months prior to randomization • Uncontrolled or symptomatic secondary hyperparathyroidism • Women with positive pregnancy tests prior to randomization • Women of childbearing potential without effective contraception or women in lactation period • Women of childbearing potential without effective contraception • Participation in a clinical trial or receipt of investigational compound or treatment within the 3 months prior to randomization • Planned elective surgery during the study period Exceptions are: • Cataract surgery • Vascular access surgery • Urethral stent removal • Nephrostomy tube replacement • Minor surgery not requiring hospitalisation • Known HIV infection • Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of subcutaneous administration of MIRCERA every two weeks, versus no ESA therapy, in CKD patients with anaemia after kidney transplant not currently treated with ESA.;Secondary Objective: To compare the Quality of Life in CKD patients with anaemia after kidney transplant who have received treatment with MIRCERA versus patients who do not have anaemia corrected (control). To investigate the effect of treatment of anaemia upon renal and other clinical outcomes (including cardiovascular events, cerebrovascular events, all cause hospitalization, need for transfusion and all cause mortality). To evaluate the safety and tolerability of MIRCERA administered every two weeks during the correction of anaemia in CKD patients after kidney transplant and then monthly for maintenance of Hb concentrations. Additional: To explore associations between NT-proBNP levels and clinical outcomes observed during the study.;Primary end point(s): Change in haemoglobin concentration between baseline and the evaluation period (EEP haemoglobin – baseline haemoglobin), where: • the baseline haemoglobin is defined as the mean of the two values recorded at weeks -4 and -2 during the screening period. • the EEP haemoglobin is defined as the time adjusted average (see section 9.2.2) of the values recorded during the Efficacy Evaluation Period. | — |
Countries
Belgium, France, Germany, Italy, Spain, United Kingdom
Outcome results
None listed