ATINO Study: A Study of Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.
- Conditions
- -D638 Anaemia in other chronic diseases classified elsewhereD638Anaemia in other chronic diseases classified elsewhere
- Registration Number
- PER-040-07
- Lead Sponsor
- PRODUCTOS ROCHE Q.F.S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 5
1. Written informed consent.
2. Age 18 years or older.
3. Chronic renal anemia.
4. Concentration of hemoglobin between 10.5 and 12.5 g / dl.
5. Suitable iron status.
6. Continuous maintenance therapy with intravenous and / or subcutaneous erythropoietin alfa with the same dosing interval during the last 2 months.
7. Regular therapy with hemodialysis or long-term peritoneal dialysis with the same mode of dialysis for a minimum of 3 months prior.
8. Kt / V ≥ 1.2 in the selection for hemodialysis patients.
9. Kt / V ≥ 1.8 in the selection for patients with peritoneal dialysis.
1. Transfusion of erythrocytes during the previous 2 months.
2. Deficiently controlled hypertension.
3. Acute or chronic heavy bleeding.
4. Active malignant disease.
5. Hemolysis: haptoglobin <30 mg / dl or other reliable positive test for hemolysis.
6. Hemoglobinopathies.
7. Folic acid deficiency, uncorrected in the last 2 months.
8. Deficiency of vitamin B12, not corrected in the last 2 months.
9. Platelet count> 500 x 10-9 / L.
10. Pure aplasia of the red series.
11. Epileptic seizures during the previous 6 months.
12. C Reactive Protein (CRP)> 30 mg / L.
13. Congestive heart failure (NYHA Class IV).
14. Myocardial infarction or cerebrovascular accident, severe or unstable coronary disease, severe liver disease at the discretion of the investigator, during the previous 3 months.
15. Non-controlled or symptomatic secondary hyperparathyroidism.
16. Pregnancy or lactation period.
17. Potentially fertile women without effective contraception.
18. Participation in a clinical study or reception of an experimental compound or experimental treatment during the previous 3 months.
19. Unknown hypersensitivity to human recombinant erythropoietin, polyethylene glycol or any component of the study drug.
20. Elective surgery planned during the study period except for cataract surgery.
21. Temporary catheter for dialysis access.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Serum levels of Hemoglobin.<br>Measure:Proportion of patients maintaining their average hemoglobin concentration (g / dl) within ± 1 g / dl with respect to their reference Hb between 10.5 and 12.5 g / dl.<br>Timepoints:Weeks 16 and 24.<br>
- Secondary Outcome Measures
Name Time Method