Neocytolysis in the Treatment of Renal Anemia With Erythropoieses Stimulating Agents

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

Sponsors

Lead sponsor: University Hospital, Basel, Switzerland

Collaborator: Roche Pharma AG

Source University Hospital, Basel, Switzerland
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.

Overall Status Completed
Start Date January 2011
Completion Date October 2011
Primary Completion Date July 2011
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Reticulocyte count on day 7 day 7
Enrollment 9
Condition
Intervention

Intervention type: Drug

Intervention name: cera, darbepoetin, epoetin-beta

Description: Epoetin once/ 2wk, cera once/ month, darbepoetin once/ 2wk

Arm group label: A

Intervention type: Drug

Intervention name: ESA

Description: Sequential application of three different ESA

Arm group label: A

Eligibility

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Michael Dickenmann, MD Principal Investigator Transplantation immunology and nephrology, unversity hospital Basel, Switzerland
Location
facility Nephrology and Transplantaton Immunology
Location Countries

Switzerland

Verification Date

October 2011

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: A

Arm group type: Experimental

Description: Sequential application of different ESA

Study Design Info

Allocation: Randomized

Intervention model: Crossover Assignment

Primary purpose: Basic Science

Masking: None (Open Label)

Source: ClinicalTrials.gov