chronic renal anemia MedDRA version: 9.1 Level: PT Classification code 10058116 Term: Nephrogenic anaemia
Conditions
Interventions
Product Name: Mircera
Product Code: RO0503821
Pharmaceutical Form: Solution for injection
INN or Proposed INN: methoxy polyethylene glycol-epoetin beta
Current Sponsor code: RO0503821
Concentration un
Sponsors
Roche Nederland B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent • Age 18 years or older • Chronic renal anaemia • Haemoglobin concentration between 10.5 and 12.5 g/dl (6.5 and 7.8 mmol/L) at the initial screening visit. • Adequate iron status (serum ferreting = 100ng/mL or TSAT=20%) during screening • Continuous subcutaneous maintenance darbepoetin alfa or epoetin beta therapy with the same dosing interval for 8 weeks prior to and throughout the screening period 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
Exclusion criteria
Exclusion criteria: • Transfusion of red blood cells during the 8 weeks prior to or during the screening period • Poorly controlled hypertension, i.e. sitting bloodpressure exceeds 170/100 despite medication requiring hospitalisation or interruption of epoetin beta or darbepoetine alfa treatment in the previous 6 months. • Significant or acute or chronic bleeding, i.e. requiring therapy within 8 weeks prior to screening e.g. 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 x 109/L or <100 x 109/L at screening visit • Pure red call aplasia • Epileptic seizure in 6 months before screening • Congestive heart failure (NYHA Class IV) • Myocardial infarction or stroke within 12 weeks of screening, severe or unstable coronary artery disease, severe liver disease • Uncontrolled or symptomatic secondary hyperparathyroidism • Pregnancy or lactation period etc. • Women of childbearing potential without effective contraception • Participation in a clinical trial or receipt of investigational compound in the 3 months prior to the initial screening visit • Planned elective surgery during the study period except for cataract surgery and vascular access surgery • 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 long term maintenance of haemoglobin levels, with once-monthly subcutaneous administration of RO0503821 in patients with chronic renal anaemia not on dialysis (CKD stages 1-4) ;Secondary Objective: To evaluate the safety and tolerability and the impact on quality of life of RO0503821 once monthly in the treatment of anaemia in patients with chronic kidney disease To explore associations between NT-proBNP levels and clinical outcomes observed during the study.;Primary end point(s): Key outcomes will be assessed during the first 8 weeks following the 16 weeks dose titration period (The Efficacy Evaluation Period – EEP). The baseline haemoglobin is defined as the mean of the assessments recorded during the SVP period. For the purposes of efficacy assessment the target haemoglobin concentration range will be defined as ± 1 g/Dl (0.6 mmol/L) of the baseline haemoglobin concentration and within the range 10.5 – 12.5g/dL (6.5 and 7.8 mmol/L). Primary Efficacy Endpoint • The proportion of patients maintaining average haemoglobin concentration during the EEP within the target range Secondary Efficacy Endpoints • Change in haemoglobin concentration between reference (SVP) and the EEP • The proportion of patients maintaining haemoglobin concentration within the haemoglobin range 10.5-12.5 g/dL (6.5 and 7.8mmol/L) throughout the EEP • Mean time spent in haemoglobin range of 10.5-12.5 g/dL (6.5 and 7.8 mmol/L). During the dose titration and efficacy evaluation periods • Proportion of patients requiring any dose adjustment • The incidence of red blood cell transfusions Additional Endpoints • Serum NT-proBNP levels at start and end of study • QoL outcomes | — |
Countries
Netherlands
Outcome results
None listed