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Trial record 1 of 1 for:    efficacy of everolimus native kidney
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The Efficacy of Everolimus in Reducing Total Native Kidney Volume in Polycystic Kidney Disease Transplanted Recipients (EVERKYSTE)

This study is currently recruiting participants.
Verified December 2015 by Assistance Publique - Hôpitaux de Paris
Sponsor:
ClinicalTrials.gov Identifier:
NCT02134899
First Posted: May 9, 2014
Last Update Posted: December 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Novartis
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose
The investigators multicenter randomized open-labelled study will investigate the efficacy of an everolimus based immunosuppression in reducing total native kidney volume in kidney recipients with autosomal dominant polycystic kidney disease compared to a calcineurin inhibitor-based immunosuppression.

Condition Intervention Phase
Autosomal Dominant Polycystic Kidney Disease Drug: Everolimus Drug: Calcineurin inhibitors maintenance Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-labelled Multicenter Randomized Study on the Efficacy of Everolimus in Reducing Total Native Kidney Volume in Kidney Transplanted Patients With Autosomal Dominant Polycystic Kidney Disease

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Total native kidney volume variation [ Time Frame: 24 months after randomization ]
    measurements of total native kidney volume with a MRI


Secondary Outcome Measures:
  • Volume variation of the biggest liver cyst [ Time Frame: 24 months after randomization ]
    Measurements of the biggest liver cyst volume with a MRI

  • Interstitial Fibrosis/Tubular Atrophy variation [ Time Frame: 24 months after randomization ]
    IF/TA quantification using Banff criteria during a kidney biopsy

  • % interstitial fibrosis using Red Sirius staining [ Time Frame: 24 months after randomization ]
    % fibrosis quantified using a morphometry software

  • Calculated Estimated Glomerular Filtration rate [ Time Frame: At baseline, 1 month, 6 months, 12 months, 18 and 24 months ]
    calculated estimated GFR

  • Measured Glomerular Filtration rate [ Time Frame: At baseline and 24 months ]
    measured GFR

  • Proteinuria [ Time Frame: At baseline, 1 month, 6 months, 12 months, 18 and 24 months ]
    Measurement

  • systolic and diastolic blood pressure [ Time Frame: At baseline, 1 month, 6 months, 12 months, 18 and 24 months ]
    Clinic measurement

  • Occurrence of diabetes or hyperlipidemia [ Time Frame: up to 24 months ]
    Measurements

  • Occurrence of neoplasia [ Time Frame: up to 24 months ]
    Medical chart reporting

  • Development of HLA Donor Specific Antibody (DSA) [ Time Frame: At baseline, 1 month, 6 months, 12 months, 18 and 24 months ]
    V0, 1 year and 2 years after randomization


Estimated Enrollment: 40
Study Start Date: May 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Everolimus
everolimus based immunosuppression
Drug: Everolimus
Change from a calcineurin inhibitors-based immunosuppression to an everolimus-based immunosuppression
Other Name: everolimus conversion
Active Comparator: Calcineurin
Calcineurin inhibitors maintenance
Drug: Calcineurin inhibitors maintenance
Usual treatment
Other Name: calcineurin-inhibitors based immunosuppression

Detailed Description:
Kidney graft recipients receiving a firs kidney graft (between 6 months and 5 years post-transplantation) will be randomized 1:1 to receive an everolimus based immunosuppression (in association with steroids and mycophenolate mofetil) or to continue their calcineurin inhibitor-based immunosuppression regimen. The primary objective will be the reduction of total native kidney volume after a 2-years treatment period.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age between 18 and 75 years-old
  • recipients of a first kidney graft between 6 month and 5 years ago with a stable eGFR above 30 ml/min/1,73m2
  • contraception for female recipients to avoid pregnancy
  • valid health Insurance during the study period

Exclusion Criteria:

  • signed informed consent not obtained
  Contacts and Locations
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): NCT02134899


Contacts
Contact: Hélène François, MD, PhD +33(1)45 21 27 22 helene.francois@bct.aphp.fr

Locations
France
Bicêtre Hospital Recruiting
Le Kremlin-Bicêtre, France, 94275
Contact: Hélène François    +33(1)45 21 27 22    helene.francois@bct.aphp.fr   
Principal Investigator: Hélène François, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Novartis
Investigators
Principal Investigator: Hélène François, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02134899     History of Changes
Other Study ID Numbers: P 090804
2012-004265-41 ( EudraCT Number )
First Submitted: April 28, 2014
First Posted: May 9, 2014
Last Update Posted: December 9, 2015
Last Verified: December 2015

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Autosomal dominant polycystic kidney disease
cyst
kidney
liver
kidney transplantation
IF/TA
fibrosis
DSA
mTOR inhibitors
calcineurin inhibitors

Additional relevant MeSH terms:
Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Kidney Diseases, Cystic
Everolimus
Sirolimus
Urologic Diseases
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn
Calcineurin Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action