Neocytolysis in the Treatment of Renal Anemia With Erythropoieses Stimulating Agents (ESA)
NCT ID: NCT01306409
Last Updated: 2011-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
9 participants
INTERVENTIONAL
2011-01-31
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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A
Sequential application of different ESA
cera, darbepoetin, epoetin-beta
Epoetin once/ 2wk, cera once/ month, darbepoetin once/ 2wk
ESA
Sequential application of three different ESA
Interventions
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cera, darbepoetin, epoetin-beta
Epoetin once/ 2wk, cera once/ month, darbepoetin once/ 2wk
ESA
Sequential application of three different ESA
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Roche Pharma AG
INDUSTRY
University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Michael Dickenmann, MD
Role: PRINCIPAL_INVESTIGATOR
Transplantation immunology and nephrology, unversity hospital Basel, Switzerland
Locations
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Nephrology and Transplantaton Immunology
Basel, Canton of Basel-City, Switzerland
Countries
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References
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Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
Other Identifiers
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362/09
Identifier Type: -
Identifier Source: org_study_id