Trial record 1 of 2 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 not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT02134899
First received: April 28, 2014
Last updated: May 8, 2014
Last verified: April 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Measurements of the biggest liver cyst volume with a MRI

  • Interstitial Fibrosis/Tubular Atrophy variation [ Time Frame: 24 months after randomization ] [ Designated as safety issue: No ]
    IF/TA quantification using Banff criteria during a kidney biopsy

  • % interstitial fibrosis using Red Sirius staining [ Time Frame: 24 months after randomization ] [ Designated as safety issue: No ]
    % 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 ] [ Designated as safety issue: No ]
    calculated estimated GFR

  • Measured Glomerular Filtration rate [ Time Frame: At baseline and 24 months ] [ Designated as safety issue: No ]
    measured GFR

  • Proteinuria [ Time Frame: At baseline, 1 month, 6 months, 12 months, 18 and 24 months ] [ Designated as safety issue: No ]
    Measurement

  • systolic and diastolic blood pressure [ Time Frame: At baseline, 1 month, 6 months, 12 months, 18 and 24 months ] [ Designated as safety issue: No ]
    Clinic measurement

  • Occurrence of diabetes or hyperlipidemia [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
    Measurements

  • Occurrence of neoplasia [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
    Medical chart reporting

  • Development of HLA Donor Specific Antibody (DSA) [ Time Frame: At baseline, 1 month, 6 months, 12 months, 18 and 24 months ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02134899

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

Locations
France
Bicêtre Hospital Not yet 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 AP-HP
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02134899     History of Changes
Other Study ID Numbers: P 090804, 2012-004265-41
Study First Received: April 28, 2014
Last Updated: May 8, 2014
Health Authority: France: Ministry of Health

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
Multicystic Dysplastic Kidney
Polycystic Kidney, Autosomal Dominant
Kidney Diseases, Cystic
Everolimus
Sirolimus
Urologic Diseases
Urogenital Abnormalities
Congenital Abnormalities
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents

ClinicalTrials.gov processed this record on September 18, 2014