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COMPLETED

NCT02328963

PHASE4

Proportion of CMV Seropositive Kidney Transplant Recipients Who Will Develop a CMV Infection When Treated With an Immunosuppressive Regimen Including Everolimus and Reduced Dose of Cyclosporine Versus an Immunosuppressive Regimen With Mycophenolic Acid and Standard Dose of Cyclosporine A

Sponsor: University Hospital, Bordeaux

View on ClinicalTrials.gov

Summary

Cytomegalovirus (CMV) infection is the most frequent opportunistic viral infection after transplantation. It is associated with an increased incidence of acute rejection and lower graft and patient survivals. The goal of this study is to demonstrate that an immunosuppressive regimen associating everolimus and reduced dose of cyclosporine A can prevent acute rejection episodes as efficiently as standard regimen but also efficiently reduce the incidence of CMV infection at 6 months post-transplantation.

Official title: A Multicenter, Two Arms, Randomized, Open Label Clinical Phase IV Study Investigating the Proportion of CMV Seropositive Kidney Transplant Recipients Who Will Develop a CMV Infection Within the First 6 Months Post-transplantation When Treated With an Immunosuppressive Regimen Including Everolimus (Certican®) and Reduced Dose of Cyclosporine A (Neoral®) Versus an Immunosuppressive Regimen With Mycophenolic Acid (Myfortic®) and Standard Dose of Cyclosporine A (Neoral®).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

186

Start Date

2014-05-02

Completion Date

2018-10-10

Last Updated

2026-07-27

Healthy Volunteers

Conditions

Transplantation Infection Cytomegalovirus Infection

Interventions

DRUG

Everolimus

Everolimus : 0.75 bid, targeted to 3-8 ng/ml Cyclosporin A : CsA target ranges for Arm 1 will be 100-200 ng/mL from Day 3 to Month 2, decreasing to 75-150 ng/mL from Month 2 to Month 4 and 25-50 ng/mL from Months 6 to 12. Corticosteroids : Méthylprednisolone: 500 mg at Day 0, 120 mg à Day 1. Prednisone or equivalent: 20 mg/d from Day 3. Corticosteroid dosing will be tapered according to center standard practice but to not less than 5 mg per day for the duration of the 12-month study Basiliximab :Day 0: 20 mg ; Day 4: 20 mg

DRUG

mycophenolic acid

Mycophenolic acid : 1080 mg bid for one month, then 720 mg bid Cyclosporin A : CsA target ranges for Arm 1 will be 100-200 ng/mL from Day 3 to Month 2, decreasing to 75-150 ng/mL from Month 2 to Month 4 and 25-50 ng/mL from Months 6 to 12. Corticosteroids : Méthylprednisolone: 500 mg at Day 0, 120 mg à Day 1. Prednisone or equivalent: 20 mg/d from Day 3. Corticosteroid dosing will be tapered according to center standard practice but to not less than 5 mg per day for the duration of the 12-month study Basiliximab :Day 0: 20 mg ; Day 4: 20 mg

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.

Locations (9)

CHU de Bordeaux

Bordeaux, France

CHU La Cavale Blanche

Brest, France

CHRU Caen - Hôpital de Caen

Caen, France

CHU de Limoges - Hôpital Dupuytren

Limoges, France

Hôpital Edouard Herriot

Lyon, France

APHP - Hôpital Necker

Paris, France

APHP - Kremlin Bicetre

Paris, France

CHRU Strasbourg

Strasbourg, France

CHU de Toulouse - Hôpital Rangueil

Toulouse, France