A new drug combo may shield kidney transplant patients from a common viral threat
NCT ID NCT02328963
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Cytomegalovirus infection are added.
Genom att skicka in godkänner du våra Användarvillkor
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Fewer dialysis sessions: can Twice-Weekly work as well?
- Can pedaling through dialysis make patients stronger?
- Can music make dialysis exercise more effective?
- Can a daily antibiotic shield dialysis patients from deadly infections?
- Warming donated kidneys may boost transplant success
- A tailored diet may lower heart risk in kidney failure