NCT04736381

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
8mo left

Started Oct 2021

Longer than P75 for all trials

Geographic Reach
1 country

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Oct 2021Jan 2027

First Submitted

Initial submission to the registry

January 29, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 3, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

October 7, 2021

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2027

Last Updated

April 10, 2025

Status Verified

January 1, 2025

Enrollment Period

5.3 years

First QC Date

January 29, 2021

Last Update Submit

April 9, 2025

Conditions

Kidney Transplant Rejection

Keywords

MicrobiotaBelataceptSecond signal inhibitor

Outcome Measures

Primary Outcomes (1)

  • Acute rejection occurence

    Occurence of cellular rejection according to the BANFF 2017

    1 year or rejection

Secondary Outcomes (3)

  • Gut and circulating microbiota

    1 year or rejection

  • Lymphocyte phenotype

    1 year or rejection

  • Glomerular filtration rate

    1 year or rejection

Study Arms (1)

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.

Drug: Belatacept Injection [Nulojix]

Interventions

Belatacept Injection [Nulojix]DRUG

Drugs administrated are part of the usual care

Also known as: Simulect, Mycophenolate mofetil, Steroid
Kidney transplanted patients treated with Nulojix

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

70 patients treated with Simulect as induction, and with Nulojix®, mycophenolic acid and steroids as maintenance therapy during the first year of kidney transplant.

You may qualify if:

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

You may not qualify if:

  • Multiple grafts combined or sequential
  • Induction therapy with polyclonal antibodies
  • HIV or active viral infection such as hepatitis B or C
  • Active bacterial infection
  • Patient unable to express their consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Nephrologie transplantation CHRU Besançon

Besançon, 25000, France

RECRUITING

Néphrologie, hémodialyse, aphérèses, transplantation rénale

La Tronche, 38700, France

RECRUITING

Nephrologie transplantation CHRU Nantes

Nantes, 44200, France

RECRUITING

Nephrologie transplantation CHU Saint Louis Paris

Paris, 75010, France

RECRUITING

Nephrologie transplantation CHU Pitié Salpetriere Paris

Paris, 75013, France

RECRUITING

Nephrologie hôpital Henri-Mondor

Paris, 94010 Créteil, France

RECRUITING

Nephrologie transplantation CHRU Poitiers

Poitiers, 86021, France

RECRUITING

Nephrologie transplantation CHRU Toulouse

Toulouse, 31059 Toulouse Cedex 9, France

RECRUITING

Nephrologie transplantation CHRU Tours

Tours, 37044, France

RECRUITING

Related Publications (2)

  • 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.

    PMID: 20634298BACKGROUND

  • 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.

    PMID: 20415898BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood Stool

MeSH Terms

Interventions

AbataceptBasiliximabMycophenolic AcidSteroids

Intervention Hierarchy (Ancestors)

ImmunoconjugatesAntibodiesImmunoglobulinsSerum GlobulinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsGlobulinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalImmunoproteinsCaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Antoine Durrbach, MD-PhD

    Institut National de la Santé Et de la Recherche Médicale, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Antoine Durrbach, MD-PhD

CONTACT

+33614112981antoine.durrbach@inserm.fr

florence Herr, PhD

CONTACT

+33663680985florence.herr@inserm.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2021

First Posted

February 3, 2021

Study Start

October 7, 2021

Primary Completion (Estimated)

January 7, 2027

Study Completion (Estimated)

January 7, 2027

Last Updated

April 10, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(9)