EUCTR2005-004510-33-ITActive, not recruitingNot Applicable
A randomized, controlled, open-label, multi-center, parallel-groupstudy to compare the efficacy and safety of RO0503821 with thatof darbepoetin alfa administered intravenously at extended dosingintervals for the maintenance treatment of anemia in patients withchronic kidney disease who are on hemodialysis
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- ROCHE
- Enrollment
- 488
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Written informed consent
- •2. Adult patients (≥ 18 years old) with chronic renal anemia
- •3. Regular long-term hemodialysis three times weekly for at
- •least 12 weeks before screening and during the screening/baseline period
- •4. Kt/V ≥ 1.2 or URR ≥ 65%
- •5. Baseline hemoglobin concentration between 11.0 and 13.0 g/dL (mean of the weekly hemoglobin values determined in weeks -4 to -1)
- •6. Stable baseline hemoglobin concentration (defined as an
- •absolute difference less than or equal to 1 g/dL between the mean hemoglobin values determined in weeks -4 and -3 and the mean hemoglobin values determined in weeks -2 and -1)
- •7. Continuous intravenous once-weekly maintenance darbepoetin therapy for at least 8 weeks before screening and
- •during the screening/baseline period
- •8. Stable intravenous once-weekly maintenance darbepoetin therapy during the screening/baseline period (a maximum of one dose change according to approved labeling)
- •9. Adequate iron status defined as serum ferritin ≥ 100 ng/mL or TSAT ≥ 20% (or percentage of hypochromic RBCs
- •< 10%) (mean of two values determined in weeks -4 and -3)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •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
- •1. History of treatment with any ESA at a dosing interval longer than once-weekly since the start of dialysis treatment
- •2. Overt gastrointestinal bleeding within 8 weeks before screening or during the screening/baseline period
- •3. RBC transfusions within 8 weeks before screening or during the screening/baseline period
- •4. Hemoglobinopathies (e.g., homozygous sickle-cell disease,
- •thalassemia of all types)
- •5. Hemolysis
- •6. Active malignancy (except non-melanoma skin cancer). Patients with malignant disease who have been disease-free for at least the 5 previous years are eligible
- •7. Chronic, uncontrolled or symptomatic inflammatory disease
- •(e.g., rheumatoid arthritis, systemic lupus erythematosus)
- •8. Acute infection
- •9. CRP > 30 mg/L
- •10. Temporary (untunneled) dialysis access catheter
- •11. Vitamin B12 deficiency
- •12. Folic acid deficiency
- •13. Uncontrolled or symptomatic secondary hyperparathyroidism
- •14. Poorly controlled hypertension necessitating interruption of
- •treatment with erythropoiesis stimulating agents in the 3 months before screening or during the screening/baseline period
- •15. Epileptic seizure in the 6 months before screening or during the screening/baseline period
- •16. Platelets > 500 x 10 9/L
- •17. Pure red cell aplasia
- •18. Chronic congestive heart failure (New York Heart Association Class IV)
- •19. High likelihood of early withdrawal or interruption of the
- •study (e.g. myocardial infarction, severe or unstable coronary artery disease, stroke or severe liver disease within the 12 weeks before screening or during the screening/baseline period)
- •20. Planned elective surgery during the study period (patients who undergo vascular access surgery, cataract surgery or laser photocoagulation may continue to participate)
- •21. Life expectancy less than 12 months
- •22. Pregnancy or breast-feeding
- •23. Women of childbearing potential without effective contraception
- •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 formulations
- •26. Previous treatment with RO0503821
Investigators
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