Neocytolysis in the Treatment of Renal Anemia With Erythropoieses Stimulating Agents (ESA)

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to gain information on reticulocyte neocytolysis in patients treated with ESA with regard to different types of ESA.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Basel, Switzerland
• Collaborator: Roche Pharma AG
• Treatments: Darbepoetin alfa; Epoetin Alfa; Hematinics

Criteria

Inclusion Criteria:

• signed informed consent

• age > 18 years, dialysis dependent chronic renal failure

• hemodialysis three times a week

• Kt/V > 1,2 od URR > 65%

• hemoglobin between 11 and 13 g/dl within the last 2 months

• hemoglobin change +/- 1g/dl within the last 4 weeks

• ESA for at least 8 weeks

• Ferritin > 300 ng/ml and Tsat > 25%

Exclusion Criteria:

• Significant bleeding in the last 8 weeks

• blood transfusion within the last 8 weeks

• hemoglobin disorder

• hemolysis

• Malignant disease

• Significant inflammation

• Acute infection

• CRP > 30 mg/l

• Temporary vascular dialysis access

• Vitamin B12 deficiency

• Folic acid deficiency

• Not controlled hyperparathyroidism

• Not controlled hypertension

• Epilepsia within thze last 6 months

• Thrombocyte count > 500 x 10^9 /l