Impact of the Microbiota on the Likelihood of Renal Graft Rejection
NCT ID: NCT04736381
Last Updated: 2025-04-10
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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RECRUITING
70 participants
OBSERVATIONAL
2021-10-07
2027-01-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Kidney transplanted patients treated with Nulojix
Patients treated with Simulect as induction, and with Nulojix®, mycophenolic acid and steroids as maintenance therapy during the first year of kidney transplant.
Belatacept Injection [Nulojix]
Drugs administrated are part of the usual care
Interventions
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Belatacept Injection [Nulojix]
Drugs administrated are part of the usual care
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Induction therapy with Simulect, maintenance therapy with Nulojix, mycophenolate acid and steroids
* Patient having signed the informed consent
Exclusion Criteria
* Induction therapy with polyclonal antibodies
* HIV or active viral infection such as hepatitis B or C
* Active bacterial infection
* Pregnancy or breastfeeding at time of inclusion
* Patient unable to express their consent
18 Years
70 Years
ALL
No
Sponsors
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Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Responsible Party
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Principal Investigators
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Antoine Durrbach, MD-PhD
Role: PRINCIPAL_INVESTIGATOR
Institut National de la Santé Et de la Recherche Médicale, France
Locations
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Nephrologie transplantation CHRU Besançon
Besançon, , France
Néphrologie, hémodialyse, aphérèses, transplantation rénale
La Tronche, , France
Nephrologie transplantation CHRU Nantes
Nantes, , France
Nephrologie transplantation CHU Saint Louis Paris
Paris, , France
Nephrologie transplantation CHU Pitié Salpetriere Paris
Paris, , France
Nephrologie hôpital Henri-Mondor
Paris, , France
Nephrologie transplantation CHRU Poitiers
Poitiers, , France
Nephrologie transplantation CHRU Toulouse
Toulouse, , France
Nephrologie transplantation CHRU Tours
Tours, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Vincenti F, Blancho G, Durrbach A, Friend P, Grinyo J, Halloran PF, Klempnauer J, Lang P, Larsen CP, Muhlbacher F, Nashan B, Soulillou JP, Vanrenterghem Y, Wekerle T, Agarwal M, Gujrathi S, Shen J, Shi R, Townsend R, Charpentier B. Five-year safety and efficacy of belatacept in renal transplantation. J Am Soc Nephrol. 2010 Sep;21(9):1587-96. doi: 10.1681/ASN.2009111109. Epub 2010 Jul 15.
Durrbach A, Pestana JM, Pearson T, Vincenti F, Garcia VD, Campistol J, Rial Mdel C, Florman S, Block A, Di Russo G, Xing J, Garg P, Grinyo J. A phase III study of belatacept versus cyclosporine in kidney transplants from extended criteria donors (BENEFIT-EXT study). Am J Transplant. 2010 Mar;10(3):547-57. doi: 10.1111/j.1600-6143.2010.03016.x.
Other Identifiers
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C 19-53
Identifier Type: -
Identifier Source: org_study_id
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