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Can kidney transplants succeed without steroids?

NCT ID NCT00200551

Disease control Sponsor: Nantes University Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

This trial tests whether a steroid-free immunosuppression regimen can prevent rejection after a first kidney transplant. Participants receive rabbit anti-T-lymphocyte serum, mycophenolate mofetil, and cyclosporine, with one group also getting standard steroids for six months and the other getting only a single steroid dose. Researchers compare the number of acute rejection episodes in the first year to see if avoiding steroids is safe and effective.

What this could mean

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

Active substance
A combination of rabbit anti-T-lymphocyte serum, mycophenolate mofetil, and cyclosporine, given without routine corticosteroids.
What this could lead to
If successful, this approach could reduce the need for long-term steroids after kidney transplant, potentially lowering the risk of heart disease and other steroid-related complications.
What could go wrong
Without steroids, patients may face a higher risk of acute rejection. The trial is open-label, so results could be influenced by expectations, and the findings may not apply to all transplant recipients.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

200 people

Start date

Jan 2001

Finished

Apr 2010

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 65 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: * Patient who is a candidate for a first cadaver renal transplantation and included on the national list of the Etablissement Français des Greffes * Man or woman aged between 18 and 65 years * Women of reproductive age must agree to use a reliable contraceptive method throughout the first year of the study * Donor aged between 18 and 65 years * Patient who has been given full information about the study and who has given his written informed consent to take part in it. Exclusion Criteria: * Women who are pregnant or breast-feeding * Patient with an immunological risk considered high and defined as a percentage of anti-HLA antibodies of ³20% (previous or recent determination of T lymphocytes) * Patient with a history of allergy to rabbit proteins * Cold ischaemia time of more than 36 hours * Patient allergic to macrolide antibiotics, to tacrolimus or to MMF * Patient on immunosuppressant treatment before transplantation * Patient suffering from a malignant neoplasm or with a history of malignant neoplasia, with the exception of treated baso- or spinocellular cancers * Patient waiting for another transplant in addition to the kidney * Patient who has already received an organ or tissue graft * Leukocyte count \<2000/mm3 and/or platelet count \<50 000/mm3 * Patient suffering from focal glomerulonephritis

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Conditions

The condition(s) this trial relates to.

chronic kidney disease

As listed by the trial registrant

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

Renal transplantation

Contacts and locations

Locations

  • Besançon Universitary Hospital

    France, Besançon, 25030, France

  • Montpellier Universitary Hospital

    Montpellier, 34059, France

  • Nantes University Hospital

    Nantes, 44093, France

  • Nice Universitary Hospital

    Nice, 06202, France

  • Strasbourg Universitary Hospital

    Strasbourg, 67091, France

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