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

University Hospital Basel

Status and phase: Completed; Phase 4

Conditions: Renal Anemia

Treatments: Drug: ESA; Drug: cera, darbepoetin, epoetin-beta

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01306409

362/09

Details and patient eligibility

About

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

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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9 participants in 1 patient group

A

Experimental group

Description:

Sequential application of different ESA

Treatment:

Drug: cera, darbepoetin, epoetin-beta

Drug: ESA