PROTECT: Prospective Trial on Erythropoietin in Clinical Transplantation
NCT ID: NCT00157300
Last Updated: 2010-08-02
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
92 participants
INTERVENTIONAL
2005-07-31
2010-07-31
Brief Summary
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The investigators postulate that erythropoietin reduces the risk of delayed graft function.
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Detailed Description
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The primary endpoint will be delayed graft function. The anticipated duration of this trial is 2 year and the target sample size is 60 patients per arm.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Epoetin beta
Epoetin beta
intravenous, 33000 IU, 3 consecutive days, starting 3-4 hours before transplantation. Total dose 100.000 IU.
Interventions
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Epoetin beta
intravenous, 33000 IU, 3 consecutive days, starting 3-4 hours before transplantation. Total dose 100.000 IU.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Receiving a kidney from a non-heart-beating donor category 3
Exclusion Criteria
18 Years
75 Years
ALL
No
Sponsors
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Leiden University Medical Center
OTHER
Responsible Party
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Leiden University Medical Center
Principal Investigators
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Ton Rabelink, MD, PhD
Role: STUDY_CHAIR
Leiden University Medical Center
Locations
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Leiden University Medical Center
Leiden, , Netherlands
Other transplantation centers
To Be Determined, , Netherlands
Countries
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References
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Ehrenreich H, Hasselblatt M, Dembowski C, Cepek L, Lewczuk P, Stiefel M, Rustenbeck HH, Breiter N, Jacob S, Knerlich F, Bohn M, Poser W, Ruther E, Kochen M, Gefeller O, Gleiter C, Wessel TC, De Ryck M, Itri L, Prange H, Cerami A, Brines M, Siren AL. Erythropoietin therapy for acute stroke is both safe and beneficial. Mol Med. 2002 Aug;8(8):495-505.
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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P05-026
Identifier Type: -
Identifier Source: org_study_id
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