Chronic renal anaemia MedDRA version: 9.1 Level: LLT Classification code 10058123 Term: Renal anaemia
Conditions
Interventions
Product Name: RO0503821
Product Code: RO0503821
Pharmaceutical Form: Injection*
INN or Proposed INN: Not available
CAS Number: 677324-53-7
Current Sponsor code: RO0503821
Concentration unit: µg/ml mic
Sponsors
Roche Oy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Written informed consent - Age 18 years or older - Patients with chronic kidney disease stage 3 (GFR 30-59 ML/min) or stage 4 (GFR 15-29 ML/min) not requiring dialysis. The GFR can be estimated either by using the Cockroft-Gault formula or the MDRD formula - Chronic renal anaemia - Haemoglobin concentration between 9 and 11 g/dl at the initial screening visit - No prior ESA therapy for 12 weeks prior to and throughout the screening period - Adequate iron status (serum ferritin = 100ng/mL or TSAT=20%) during screening 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: - Change in haemoglobin concentration = 2g/dL during the 4 weeks screening period - Transfusion of red blood cells during the 8 weeks prior to the screening visit or during the screening period - Poorly controlled hypertension - Relevant 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 - Haemoglobinopathies (e.g homozygous sickle-cell disease, thalassemia of all types) - Folic acid deficiency - Vitamin B12 deficiency - Platelet count > 500 x 109/L or 30mg/L - Congestive heart failure (NYHA Class IV) - High likelihood of early withdrawal or interuption of the study (e.g. Myocardial infarction or stroke within 12 weeks of screening, severe or unstable coronary artery disease, severe liver disease) - Failing renal allograft in place (renal graft rejection) - Immunosuppressive therapy (other than corticosteroids for a chronic condition) in 12 weeks before screening - Uncontrolled or symptomatic secondary hyperparathyroidism - Pregnancy or lactation period - Women of childbearing potential without effective contraception - Participation in a clinical trial or receipt of investigational compound or treatment in the 3 months prior to the initial screening visit - Planned elective surgery during the study period except for - cataract surgery - vascular access surgery - Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication - Previous treatment with RO0503821
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the change in haemoglobin levels, with monthly subcutaneous administration of RO0503821 in patients not on dialysis with chronic renal anaemia, not currently treated with ESA.;Secondary Objective: To evaluate the safety and tolerability of RO0503821 monthly dosing in the treatment of anaemia in patients with chronic kidney disease Additional: To explore associations between NTerminal proBNP levels and clinical outcomes observed during the study. To investigate the changes from baseline in health-related quality of life in this patient population, after correction of anemia with subcutaneous once monthly administration of C.E.R.A. ;Primary end point(s): Primary efficacy endpoint: Change in Hb concentration between the screening period and the Evaluation period Primary safety endpoint: Overall incidence of adverse events between study entry and the end of the long term safety period | — |
Countries
Estonia, Finland, Latvia
Outcome results
None listed