Chronic renal anemia MedDRA version: 8.1 Level: LLT Classification code 10058124 Term: Nephrogenic anemia
Conditions
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent 2. Adult patients (=18 years old) with CKD stage 3 (CrCl/Glomerular filtration rate (GFR) 30-59 mL/min/1.73m2) or stage 4 (CrCl/GFR 15-29 mL/min/1.73m2) not requiring dialysis. CrCl/GFR will be estimated at the first screening visit with the Cockcroft-Gault equation or the abbreviated MDRD equation, derived from the full MDRD equation. 3. Anemia defined as baseline Hb concentration =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previous therapy with any ESA within 12 weeks prior to the first screening visit or during the screening period. If ESA treatment has been interrupted for at least 12 weeks, the patient may be enrolled in the study. Ongoing ESA treatment should not be discontinued to allow participation in the trial 2. Renal allograft in place 3. Immunosuppressive therapy (other than corticosteroids for a chronic condition, cyclosporine and monoclonal/polyclonal antibodies) in the 12 weeks before the first screening visit or during the screening period 4. Overt gastrointestinal bleeding within 8 weeks before screening or during the screening period 5. RBC transfusions within 8 weeks before screening or during the screening period 6. Hemoglobinopathies (e.g., homozygous sickle-cell disease, thalassemia of all types) 7. Hemolysis 8. Active malignant disease (except non-melanoma skin cancer). Patients with malignant disease who have been disease-free for at least the 5 previous years are eligible 9. Acute infection 10. Vitamin B12 deficiency 11. Folic acid deficiency 12. Poorly controlled hypertension (sitting SBP =160 mmHg or DBP =100 mmHg – average of two values with at least one day between measurements) 13. Epileptic seizure in the 6 months before screening 14. Pure red cell aplasia (PRCA) or history of PRCA 15. Planned elective surgery during the study period (patients who undergo vascular access surgery, cataract surgery or laser photocoagulation are eligible) 16. Life expectancy less than 12 months 17. Pregnancy or breast-feeding 18. Women of childbearing potential without effective contraception 19. Administration of another investigational drug within 4 weeks before screening or planned during the study period 20. Known hypersensitivity to any constituents of the study or reference drug formulations 21. Previous treatment with RO0503821
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To demonstrate the efficacy of once every four weeks RO0503821 treatment administered subcutaneously (SC) for correction of anemia in chronic kidney disease (CKD) patients who are not on dialysis, and not treated with erythropoiesis stimulating agents [ESAs];Secondary Objective: - To assess hemoglobin (Hb) concentration over time - To assess time to response - To assess the incidence of red blood cell (RBC) transfusion - To assess the safety and tolerability of multiple SC doses of RO0503821 during the correction/evaluation period in this patient population - To compare, in each treatment group, the percentage of patients having at least one Hb exceeding 12.0 g/dL during the first 8 weeks of the study - To assess the proportion of patients who achieve a stable Hb response - To assess the total number of dose adjustments needed to achieve stabilized response Diagnostics objectives: - To assess the risk stratification value of NT-proBNP for cardiovascular events in CKD patients not on dialysis undergoing ESA treatment - To assess the risk predictive value of NT-proBNP and/or troponin T for therapeutic monitoring in CKD patients not on dialysis undergoing ESA treatment - To assess the prediction potential of NT-proBNP for dialysis initiation;Primary end point(s): 1) The Hb response rate (r) until the end of the evaluation period. 2) The change in average Hb concentration between the baseline and evaluation periods. The assessment of response is based on weekly Hb measurements and defined as an increase in Hb =1.0 g/dL from baseline and a Hb concentration =10 g/dL without RBC transfusion before response by the end of the study. The average baseline value will be estimated by calculating the mean of all values recorded between the day of first dose and the previous 20 days. The value on the day of the first dose is included in the baseline calculation, as this assessment will be performed before the first dose is given. The study aims to demonstrate th | — |
Countries
France, Germany, Greece, Hungary, Italy, Spain, Sweden
Outcome results
None listed