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

Renal Anemia Clinical Trial

Official title:

Neocytolysis in the Treatment of Renal Anemia With Erythropoieses Stimulating Agents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01306409
• Other study ID #: 362/09
• Status: Completed
• Phase: Phase 4
• First received: February 15, 2011
• Last updated: October 18, 2011
• Start date: January 2011
• Est. completion date: October 2011

Study information

• Verified date: October 2011
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: October 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Anemia
• Renal Anemia

Intervention

Drug:
• cera, darbepoetin, epoetin-beta
Epoetin once/ 2wk, cera once/ month, darbepoetin once/ 2wk
• ESA
Sequential application of three different ESA

Locations

Country	Name	City	State
Switzerland	Nephrology and Transplantaton Immunology	Basel	BS

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Roche Pharma AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reticulocyte count on day 7		day 7	No