Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Kidney transplant breakthrough: Biopsy-Guided drug adjustments could save grafts

NCT ID NCT02444429

Disease control Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a routine biopsy three months after kidney transplantation can help doctors adjust immunosuppressive drugs to prevent graft loss and reduce side effects. 346 patients were split into two groups: those with mild inflammation received extra steroids, while those without inflammation had their steroids reduced. The goal was to see if these tailored approaches improve kidney function and reduce damage.

What this could mean

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

Active substance
Corticosteroid boluses (methylprednisolone) and corticosteroid withdrawal
What this could lead to
If successful, this could lead to better long-term kidney transplant survival and fewer side effects from immunosuppressants.
What could go wrong
This is a completed phase 3 trial, but results may not apply to all transplant patients. Risks include rejection or infection from changing immunosuppression.

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.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

346 people

The number who actually took part.

Started

Sep 2015

Finished

Jun 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

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: 1. Common to both sub-studies (A and B) * Renal transplant patient aged between 18 and 75. * Patient who received a first or second renal graft * Immunosuppressive treatment consisting of an anti-calcineurin \[cyclosporine (trough levels: 150\<T0\<300)\], or tacrolimus (trough levels: 8\<T0\<12), mycophenolate mofetil and corticosteroids. * Patient who benefited from a screening renal biopsy 3 months after the graft * Patient who gave their informed consent * Patient affiliated to a social security scheme or being a beneficiary of such a scheme 2. Specific to sub-study A * Presence of "borderline" inflammatory infiltrates on the screening biopsy at 3 months as defined by the Banff classification 2013: * Absence of vascular lesions (v0) and: * tubulitis regardless of its significance (t1-3) with minimum interstitial infiltrate (i0-i1) OR * interstitial infiltrates (i2-3) without significant tubulitis (≤ t1) 3. Specific to sub-study B Absence of significant inflammatory infiltrates (i0-1 and t0) on the screening biopsy at 3 months Exclusion Criteria: 1. Common to both sub-studies (A and B) * Histological subclinical rejection criteria on the screening biopsy at 3 months (Banff 2009: \> i2+t2) * Donor specific antibodies in historical serum or de novo appearance during the first 3 months * Humoral lesions on the 3-month biopsy (Banff score g+ptc\>2) * "Classic" acute rejection episode proven by biopsy during the first 3 months * Multiorgan transplantation * 3rd (or subsequent) renal transplantation * BK virus-associated nephropathy on the screening biopsy * Contraindication to the 1-year screening biopsy 2. Specific to sub-study B Initial nephropathy with a high risk of recurrence on corticosteroid withdrawal: segmental and focal and segmental glomerulosclerosis, lupus nephritis, vasculitis, or membranous glomerulonephritis

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for End stage renal failure are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

end stage renal failure

As listed by the trial registrant

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

Renal transplantation

Contacts and locations

Locations

  • Département de Néphrologie et Transplantation d'Organes - Hôpital Rangueil - CHU de Toulouse

    Toulouse, 31059, France

  • Institut de Transplantation, Urologie et Néphrologie (ITUN) - CHU de Nantes

    Nantes, 44093, France

  • Service de Néphrologie - Hôpital Claude Huriez - CHU de Lille

    Lille, 59037, France

  • Service de Néphrologie et Transplantation - Nouvel Hôpital Civil - CHRU Strasbourg

    Strasbourg, 67091, France

  • Service de Néphrologie, Hémodialyse, Transplantations Rénales - Hôpital de la Cavale Blanche - CHU de Brest

    Brest, 29609, France

  • Service de Néphrologie, Transplantation et Immunologie Clinique - Hôpital Edouard Herriot - Hospices Civils de Lyon

    Lyon, 69437, France

  • Service de Néphrologie,Transplantation, Dialyse I - Hôpital Pellegrin - CHU Bordeaux

    Bordeaux, 33000, France

  • Service de Transplantation - Hôpital Universitaire Necker

    Paris, 75015, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.