An open-label, randomized, multi-center, parallel group non-inferiority study of subcutaneous injections of RO0503821 given once monthly vs. darbepoetin alfa given according to local label in patients with chronic kidney disease who are not on dialysis - SUSTENTO
- Conditions
- Chronic kidney diseaseMedDRA version: 8.1Level: LLTClassification code 10058124Term: Nephrogenic anemia
- Registration Number
- EUCTR2006-004552-21-CZ
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
1. Written informed consent
2. Adults patients (= 18 years old) with CKD stage 3 (creatinine clearance (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. Continuous sc maintenance darbepoetin alfa therapy with the same dosing interval (i.e., once a week, once every two weeks or once every month as per local label) for at least 8 weeks before screening and during the screening/baseline period (a maximum of one missed dose in the 12 weeks before randomization in case of weekly administration is allowed)
4. Stable sc maintenance darbepoetin alfa therapy during the screening/baseline period (no dose change is allowed)
5. Baseline Hb concentration between 10.5 and 12.0 g/dL (10.5 =Hb = 12.0 g/dL) (mean of three weekly Hb values determined in week -4, week -2 and visit # 1 before drug administration)
6. No single Hb value <10.3 g/dL in week -4, week -2 and visit # 1 before drug administration
7. Hb value at visit # 1 (before drug administration) less than 12.0 g/dL (Hb < 12.0 g/dL)
8. Stable Hb concentration (defined as any absolute difference of less than or equal 1.2 g/dL between the Hb values measured in week -4, -2 and visit # 1)
9. Adequate iron status defined as serum ferritin = 50 ng/mL or TSAT = 15% (or percentage of hypochromic RBCs < 10%) (mean of two values determined in weeks -4 and -2).
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
1. Need for dialysis therapy expected in the next 36 weeks or rapid progression of CKD (e.g., a CrCl/GFR decrease of more than 20% within 12 weeks)
2. Overt gastrointestinal bleeding within 8 weeks before screening or during the screening/baseline period
3. Renal allograft in place
4. Immunosuppressive therapy (other than corticosteroids for a chronic condition, cyclosporine, and monoclonal/polyclonal antibodies) in the 12 weeks before the first screening visit or occurring during the screening/baseline period
5. RBC transfusions within 8 weeks before screening or during the screening/baseline 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. Chronic, uncontrolled or symptomatic inflammatory disease (e.g., rheumatoid arthritis, systemic lupus erythematosus)
10. Acute infection
11. Vitamin B12 deficiency
12. Folic acid deficiency
13. Uncontrolled or symptomatic secondary hyperparathyroidism
14. Poorly controlled hypertension necessitating interruption of epoetin or darbepoetin alfa treatment in the 6 months before screening
15. Epileptic seizure in the 6 months before screening or during the
screening/baseline period
16. Pure red cell aplasia (PRCA) or history of PRCA
17. Chronic congestive heart failure (New York Heart Association Class IV)
18. High likelihood of early withdrawal or interruption of the study (e.g., myocardial infarction, severe or unstable coronary artery disease, stroke, severe liver disease within the 12 weeks before screening or during the screening/baseline period)
19. Planned elective surgery during the study period (patients who undergo vascular access surgery, cataract surgery or laser photocoagulation may continue to participate)
20. Life expectancy less than 12 months
21. Pregnancy or breast-feeding
22. Women of childbearing potential without effective contraception
23. Previous treatment with RO0503821
24. Administration of another investigational drug within 4 weeks before screening or planned during the study period
25. Known hypersensitivity to darbepoetin alfa, recombinant human erythropoietin, polyethylene glycol or to any constituent of the study or reference drug formulation
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