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Your gut bacteria might predict transplant rejection

NCT ID NCT04736381

Knowledge-focused Sponsor: Institut National de la Santé Et de la Recherche Médicale, France Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This study looks at whether the bacteria in your gut and blood can help predict if a kidney transplant will be rejected. Researchers will follow 70 people who are getting a kidney transplant and taking a drug called Nulojix (belatacept) as part of their usual care. They will collect stool and blood samples to look for bacterial patterns that might be linked to acute rejection during the first year after transplant. The goal is to find a simple way to identify patients at higher risk, so doctors can act sooner.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Belatacept (Nulojix) and standard immunosuppressive drugs
What this could lead to
If certain bacteria are linked to rejection, doctors might one day use a simple stool or blood test to catch rejection earlier and tailor treatments.
What could go wrong
This is a small, observational study, so it may not find a clear bacterial signature. Also, the results may not apply to all transplant patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

70 people

The number who actually took part.

Started

Oct 2021

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

transplant rejection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Kidney transplant rejection

Contacts and locations

Locations

  • Nephrologie hôpital Henri-Mondor

    Paris, 94010 Créteil, France

  • Nephrologie transplantation CHRU Besançon

    Besançon, 25000, France

  • Nephrologie transplantation CHRU Nantes

    Nantes, 44200, France

  • Nephrologie transplantation CHRU Poitiers

    Poitiers, 86021, France

  • Nephrologie transplantation CHRU Toulouse

    Toulouse, 31059 Toulouse Cedex 9, France

  • Nephrologie transplantation CHRU Tours

    Tours, 37044, France

  • Nephrologie transplantation CHU Pitié Salpetriere Paris

    Paris, 75013, France

  • Nephrologie transplantation CHU Saint Louis Paris

    Paris, 75010, France

  • Néphrologie, hémodialyse, aphérèses, transplantation rénale

    La Tronche, 38700, France

  • Service de néphrologie et transplantation adulte. Hôpital Necker

    Paris, 75015, France

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