Impact of the Microbiota on the Likelihood of Renal Graft Rejection

Kidney Transplant Rejection Clinical Trial

— MERRLIN  

Official title:

Impact of the Microbiota on the Likelihood of Renal Graft Rejection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04736381
• Other study ID #: C 19-53
• Status: Not yet recruiting
• Start date: April 14, 2021
• Est. completion date: September 27, 2024

Study information

• Verified date: January 2021
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: Antoine Durrbach, MD-PhD
• Phone: +33614112981
• Email: antoine.durrbach[@]inserm.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Identification of a bacterial signature in the blood or stool that may be associated with acute rejection in patients treated with Nulojix during their first year of transplant.

Description:

Gut microbiota as well as the signature of the 16S plasma bacterial DNA and bacterial metabolites of patients on the date of transplantation and during the first year after transplantation will be analyzed. The phenotype of the patients' T lymphocytes will be analyzed at the same time. These data will be correlated with the occurrence of acute cell rejection during the first year of transplantation

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: September 27, 2024
• Est. primary completion date: September 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients called for a kidney transplant
• Induction therapy with Simulect, maintenance therapy with Nulojix, mycophenolate acid and steroids
• Patient having signed the informed consent

Exclusion Criteria:

• Multiple grafts combined or sequential
• 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

Related Conditions & MeSH terms

• Kidney Transplant Rejection

Intervention

Drug:
• Belatacept Injection [Nulojix]
Drugs administrated are part of the usual care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

References & Publications (2)

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, Grinyó 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. — View Citation

Vincenti F, Blancho G, Durrbach A, Friend P, Grinyo J, Halloran PF, Klempnauer J, Lang P, Larsen CP, Mühlbacher 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute rejection occurence	Occurence of cellular rejection according to the BANFF 2017	1 year or rejection
Secondary	Gut and circulating microbiota	16S DNA sequencing	1 year or rejection
Secondary	Lymphocyte phenotype	CD3+CD4+CD57+PD1-, CD3+CD8+CD28low, CD3+CD8+CD45RA phenotype	1 year or rejection
Secondary	Glomerular filtration rate	CDK-EPI creatinine equation	1 year or rejection