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Trial record 4 of 36 for:    "Viral Infectious Disease" | "Everolimus"

Multicenter Randomized Two-arms Study Evaluating the BK Viral Clearance in Kidney Transplant Recipients With BK Viremia. (BK EVER)

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ClinicalTrials.gov Identifier: NCT03216967
Recruitment Status : Recruiting
First Posted : July 13, 2017
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Brief Summary:
BK virus nephropathy (BKVN), a consequence of the strong immunosuppressive therapy given after kidney transplantation, represents a growing problem in the kidney transplant (KT) setting. In recent cohorts, BKVN concerns up to 10% of kidney transplant recipients and early signs of BK virus (BKV) infection as development of asymptomatic viruria and viremia are even much more frequent (40% and 20% of patients, respectively). In this context, finding strategies to prevent BKV infection or treat patients before the occurrence of BKV nephropathy is challenging. For several years, detection of BKV replication by real-time PCR in urine and/or blood of kidney transplant recipients at early stages of infection allowed adaptation of their therapy. As BKV reactivates essentially in patients with over-immunosuppression, the first step of the treatment is the reduction of immunosuppression. However, reducing immunosuppression (IS) can lead to acute rejection and allograft loss. Other treatments have been proposed (cidofovir, quinolones) but their toxicity profile or their lack of clinical efficacy are now demonstrated. Hence, an efficient and safe strategy against uncontrolled BKV replication is urgently needed. MTor-inhibitors are well known immunosuppressive drugs used in organ transplantation to prevent graft-rejection. They have furthermore anti-viral effects that can be beneficial for prevention of viral infections after transplantation. Recent evidence that inhibition of mTor pathway had an impact on BK infected cells provides additional insight into the observed benefits associated with these drugs. The aim of our study is to evaluate the effect of the mTor inhibitor everolimus on the prevention of severe BKV infection (BKV nephropathy or loss of the allograft) after kidney transplantation compared to the reduction of immunosuppression alone in kidney recipients with BK viremia.

Condition or disease Intervention/treatment Phase
BK Virus Nephropathy After Kidney Transplantation Drug: everolimus Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Randomized Two-arms Study Evaluating the BK Viral Clearance in Kidney Transplant Recipients With BK Viremia After Reduction of Immunosuppression Alone vs. Reduction of Immunosuppression and Replacement of Mycophenolate Mofetil by Everolimus
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: IS lowering alone
50% decrease of the dose of mycophenolic acid at M1 (target AUC 20 mg.h/L)
Drug: everolimus
Patients with viremia above 3 log of copies/ml will be randomized (ratio 1:1) into either of 2 groups Group 1 : control group : immunosuppression lowering or Group 2 : experimental group : immunosuppression lowering and replacement of mycophenolate acid by everolimus Evolution of BKV viremia and allograft function will be assessed during 2 years after randomization

Experimental: Everolimus + IS lowering
Stop mycophenolate acid (Cellcept or myfortic) Introduction of everolimus : 2 x 0.75 mg/d per os in patiens treated by ciclosporine
Drug: everolimus
Patients with viremia above 3 log of copies/ml will be randomized (ratio 1:1) into either of 2 groups Group 1 : control group : immunosuppression lowering or Group 2 : experimental group : immunosuppression lowering and replacement of mycophenolate acid by everolimus Evolution of BKV viremia and allograft function will be assessed during 2 years after randomization




Primary Outcome Measures :
  1. The main objective of our study is to evaluate the proportion of patients with BKV clearance 6 months after introduction of everolimus in kidney recipients who develop BKV viremia compared to patients managed with IS reduction alone [ Time Frame: 6 months after randomization ]
    The primary end point is the proportion of patients with clearance of BK viremia assessed by blood PCR and functional graft 6 months after modification of immunosuppressive therapy



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients
  • Kidney transplant recipients
  • Patients treated by a calcineurin inhibitor and mycophenolic acid
  • Viremia >= 3 log UI/ml
  • Patients who have given written informed consent
  • Negative pregnancy test (blood β-HCG dosage)

Exclusion Criteria:

  • Known proved BKV nephropathy
  • Hypersensitivity to everolimus, sirolimus or excipient
  • Concomitant treatment by leflunomide, cidofovir, sirolimus, Millepertuis (Hypericum Perforatum)
  • Pregnant or lactating women
  • Women of child bearing potential unless they are using a birth control method

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03216967


Contacts
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Contact: Sophie Caillard 0369550511 sophie.caillard@chru-strasboourg.fr

Locations
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France
CHU - Hôpital Sud Recruiting
Amiens, France, 80054
Contact: Maité JAUREGUY, MD         
CHRU d'Angers Recruiting
Angers, France, 49033
Contact: Johnny SAYEGH, MD         
CHU - Hôpital de la Cavale Blanche Recruiting
Bois-guillaume, France, 76230
Contact: Dominique BERTRAND, MD         
CHU - Hôpital de la Cavale Blanche Recruiting
Brest, France, 29609
Contact: Yannick LE MEUR, MD         
CHU Côte de Nacre Recruiting
Caen, France, 14033
Contact: Nicolas BOUVIER, MD         
CHU Hôpital Gabriel Montpied Recruiting
Clermont-Ferrand, France, 63000
Contact: Anne Elisabeth HENG, MD         
CHU - Hôpital Dupuytren Recruiting
Limoges, France, 87042
Contact: Jean Philippe REROLLE, MD         
AP-HP Hôpital Necker Recruiting
Paris, France, 75743
Contact: Dany ANGLICHEAU, MD         
AP-HP - Hôpital Georges Pompidou Recruiting
Paris, France, 75908
Contact: Eric THERVET, MD         
CHU Poitiers - Hôpital Jean Bernard Recruiting
Poitiers, France, 86021
Contact: Laure ECOTIERE, MD         
CHU - Hôpital Maison Blanche Recruiting
Reims, France, 51092
Contact: Betoul SCHVARTZ, MD         
CHU Rennes - Hôpital Pontchaillou Recruiting
Rennes, France, 35033
Contact: Léonard GOLBIN, MD         
Les Hôpitaux Universitaires Recruiting
Strasbourg, France, 67000
Contact: Sophie CAILLARD, MD         
CHRU - Hôpital Bretonneau Recruiting
Tours, France, 37044
Contact: Matthias BUCHLER, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France

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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT03216967     History of Changes
Other Study ID Numbers: 6646
First Posted: July 13, 2017    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Virus Diseases
Everolimus
Viremia
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Sirolimus
Mycophenolic Acid
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antibiotics, Antitubercular
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action