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Completed

NCT Number: NCT02134899

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

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.

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Key information

Conditions

Autosomal Dominant Polycystic Kidney Disease Abnormalities, Multiple Ciliopathies Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cysts Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fibrosis Genetic Diseases, Inborn Kidney Diseases Kidney Diseases, Cystic Male Urogenital Diseases Neoplasms Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bicêtre Hospital

Le Kremlin-Bicêtre, 94275, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Everolimus

Drug

Change from a calcineurin inhibitors-based immunosuppression to an everolimus-based immunosuppression

Other names: everolimus conversion

Calcineurin inhibitors maintenance

Drug

Usual treatment

Other names: calcineurin-inhibitors based immunosuppression

Primary outcomes

  1. Total native kidney volume variation

    Time frame: 24 months after randomization

    measurements of total native kidney volume with a MRI

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Novartis

Registry information

Official study 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

Acronym: EVERKYSTE

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 9, 2014
Registry last updated
Dec 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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