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The Efficacy of Everolimus in Reducing Total Native Kidney Volume in Polycystic Kidney Disease Transplanted Recipients (EVERKYSTE)

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ClinicalTrials.gov Identifier: NCT02134899
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : December 10, 2018
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
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 or disease Intervention/treatment Phase
Autosomal Dominant Polycystic Kidney Disease Drug: Everolimus Drug: Calcineurin inhibitors maintenance Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
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
Actual Study Start Date : October 14, 2014
Actual Primary Completion Date : November 11, 2017
Actual Study Completion Date : November 11, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
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




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


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

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

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

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

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

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

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

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

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

  10. 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

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


Locations
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France
Bicêtre Hospital
Le Kremlin-Bicêtre, France, 94275
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Novartis
Investigators
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Principal Investigator: Hélène François, MD, PhD Assistance Publique - Hôpitaux de Paris

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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 Posted: May 9, 2014    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018
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:
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Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Kidney Diseases, Cystic
Abnormalities, Multiple
Congenital Abnormalities
Ciliopathies
Genetic Diseases, Inborn
Sirolimus
Everolimus
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