Renal Anemia
Conditions
Keywords
anemia, kidney disease
Brief 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.
Interventions
DRUGcera, darbepoetin, epoetin-beta
Epoetin once/ 2wk, cera once/ month, darbepoetin once/ 2wk
DRUGESA
Sequential application of three different ESA
Sponsors
Roche Pharma AG
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reticulocyte count on day 7 | day 7 |
Countries
Switzerland
Outcome results
None listed