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Impact of the Microbiota on the Likelihood of Renal Graft Rejection

ConditionKidney Transplant Rejection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorInstitut National de la Santé Et de la Recherche Médicale, France

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients called for a kidney transplant

Induction therapy with Simulect, maintenance therapy with Nulojix, mycophenolate acid and steroids

Patient having signed the informed consent

Disqualifiers

Multiple grafts combined or sequential

Induction therapy with polyclonal antibodies

HIV or active viral infection such as hepatitis B or C

Active bacterial infection

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Belatacept Injection [Nulojix]

    Drug

    Drugs administrated are part of the usual care

Treatment groups

70 Participants
are divided into 1 treatment group
Group A: Kidney transplanted patients treated with Nulojix1 intervention

Trial outcomes

Primary outcomes

1

Acute rejection occurence

Occurence of cellular rejection according to the BANFF 2017

Time frame
1 year or rejection

Secondary outcomes

1

Gut and circulating microbiota

16S DNA sequencing

Time frame
1 year or rejection
2

Lymphocyte phenotype

CD3+CD4+CD57+PD1-, CD3+CD8+CD28low, CD3+CD8+CD45RA phenotype

Time frame
1 year or rejection
3

Glomerular filtration rate

CDK-EPI creatinine equation

Time frame
1 year or rejection

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Source ClinicalTrials.gov
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