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
- Conditions
- Chronic kidney diseaseMedDRA version: 8.1Level: LLTClassification code 10058124Term: Nephrogenic anemia
- Registration Number
- EUCTR2006-004552-21-FR
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 264
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) or stage 4 (CrCl/GFR 15-29 mL/min) 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 13 g/dL (mean of three weekly Hb values determined in week -4, week -2 and visit # 1 before drug administration). Patients with a single Hb value <10.3 g/dL during the screening/baseline period will not be included.
6. 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)
7. 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 requiring antibiotics
11. CRP > 15 mg/L
12. Vitamin B12 deficiency
13. Folic acid deficiency
14. Uncontrolled or symptomatic secondary hyperparathyroidism
15. Poorly controlled hypertension necessitating interruption of epoetin or darbepoetin alfa treatment in the 6 months before screening
16. Epileptic seizure in the 6 months before screening or during the screening/baseline period
17. Platelets > 500 x 10 exp9/L
18. Pure red cell aplasia (PRCA) or history of PRCA
19. Chronic congestive heart failure (New York Heart Association Class IV)
20. 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)
21. Planned elective surgery during the study period (patients who undergo vascular access surgery, cataract surgery or laser photocoagulation may continue to participate)
22. Life expectancy less than 12 months
23. Pregnancy or breast-feeding
24. Women of childbearing potential without effective contraception
25. Previous treatment with RO0503821
26. Administration of another investigational drug within 4 weeks
before screening or planned during the study period
27. 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