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A new drug combo may shield kidney transplant patients from a common viral threat

NCT ID NCT02328963

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time

Summary

This trial compares two immunosuppressive regimens in CMV-positive kidney transplant recipients. One group receives everolimus with a reduced dose of cyclosporine A, while the other gets standard mycophenolic acid with full-dose cyclosporine. The goal is to see whether the everolimus-based regimen can prevent CMV infection and graft loss as effectively as the standard approach, while potentially lowering infection rates.

What this could mean

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

Active substance
everolimus and reduced-dose cyclosporine A
What this could lead to
If successful, this approach could reduce the risk of CMV infection after kidney transplant while maintaining effective rejection prevention.
What could go wrong
This is a phase 4 study with a moderate sample size; results may not apply to all transplant recipients, and the regimen carries risks of side effects like infection or kidney toxicity.

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

186 people

The number who actually took part.

Started

May 2014

Finished

Oct 2018

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 years and older

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: * Age ≥ 18 years. * End stage kidney disease and a suitable candidate for primary renal transplantation or re-transplantation. * Patient seropositive for CMV (confirmed within two weeks post-transplant) and having received an allograft from a CMV seropositive or seronegative donor. * Receiving a kidney transplant from a deceased or living donor with compatible ABO blood type. * Female subject of childbearing potential must have a negative serum pregnancy test at enrollment and must agree to maintain effective birth control during the study and two months later the discontinuation of the test drug. * Total ischemia time below 36 hours. * Capable of understanding the purpose and risks of the study. * Fully informed and having given written informed consent (signed Informed Consent has been obtained). * Affiliation to the social security regimen Exclusion Criteria: * CMV seronegative patient. * Historical or current TGI (French equivalence of calculated PRA) \> 85 % * Presence of historical or current anti-HLA donor specific antibodies * Patient who received anti-CMV therapy within the past 30 days prior to screening. * Receiving or having previously received an organ transplant other than a kidney. * Receiving a graft from a non-heart-beating donor. * Patient known to be positive for Human Immunodeficiency Virus (HIV), Hepatitis B (HBV; HBs Ag positive) or Hepatitis C (HCV; anti-HCV Ab positive).elevated SGPT/ALT and/or SGOT/AST and/or total bilirubin levels ≥ 2 times the upper value of the normal range of the investigational site or receiving a graft from a hepatitis C or B positive donor. * Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer. * Known allergy or intolerance to everolimus, valganciclovir, ganciclovir, mycophenolic acid, basiliximab, corticosteroids, or cyclosporine A or any of the product excipients. * Severe hyperlipidemia defined by: total cholestérol ≥ 9,1 mmol/L (≥ 350 mg/dL) et/ou triglycérides ≥ 8,5 mmol/l (≥ 750 mg/dL) in spite an adequate medication. * Patient has adequate hematological post-transplant defined as: 1. Absolute neutrophil count (ANC) \> 1000 cells/μL. 2. Platelet count \> 50,000 cells/μL. 3. Hemoglobin \> 8.0 g/dL. * Requiring initial therapy with induction immunosuppressive antibody preparations, such as anti-thymocyte globulins or rituximab or IVIG. * Currently participating in another clinical trial investigating drugs. Observational studies are not considered as an exclusion criteria * Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator. * Unlikely to comply with the visits scheduled in the protocol.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • APHP - Hôpital Necker

    Paris, 75015, France

  • APHP - Kremlin Bicetre

    Paris, 94275, France

  • CHRU Caen - Hôpital de Caen

    Caen, 14033, France

  • CHRU Strasbourg

    Strasbourg, France

  • CHU La Cavale Blanche

    Brest, 29609, France

  • CHU de Bordeaux

    Bordeaux, 33000, France

  • CHU de Limoges - Hôpital Dupuytren

    Limoges, France

  • CHU de Toulouse - Hôpital Rangueil

    Toulouse, 31000, France

  • Hôpital Edouard Herriot

    Lyon, 69003, France

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