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

Related Clinical Trial
IMPEDE-PKD Randomised Placebo-controlled Trial Daily Caloric Restriction in ADPKD To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AL01211 in Healthy Volunteers and Autosomal Dominant Polycystic Kidney Disease Subjects Establishment of the Human Intestinal and Salivary Microbiota Biobank – Kidney Diseases NOX4 and Related Biomarkers in ADPKD A Study to Evaluate the Effects of GLPG2737 in Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD) An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE) PErfusioN, OxyGen ConsUmptIon and ENergetics in ADPKD (PENGUIN) PKD Biomarkers Study Sirolimus for Massive Polycystic Liver Wishing to Decrease Aquaresis in ADPKD Patients Treated With a V2Ra; the Effect of Regulating Protein and Salt The German ADPKD Tolvaptan Treatment Registry A New Diet for Patients With Autosomal Dominant Polycystic Disease (ADPKD) Statin Therapy in Patients With Early Stage ADPKD Evaluation of Iliac and Renal Artery for Mechanism of Intracranial Aneurysm in ADPKD A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases – PHOENIX PKD Clinical and Translational Core Study Dynamic Measurement of Renal Functional Reserve as a Predictor of Long-Term Renal Function Mesenchymal Stem Cells Transplantation in Patients With Chronic Renal Failure Due to Polycystic Kidney Disease Renal Sympathetic Denervation for Reduction of Pain and Improvement of Insulin Sensitivity in Adult Polycystic Kidney Disease Evaluation of Nephrectomy Specimen for Intracranial Aneurysm Development in ADPKD Lanreotide In Polycystic Kidney Disease Study Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease Dietary Intervention in ADPKD on Tolvaptan High Water Intake in Polycystic Kidney Disease Efficacy and Safety of Lixivaptan in the Treatment of Autosomal Dominant Polycystic Kidney Disease Long-Term Treatment and Follow up of Subjects Completing 24 Months of Treatment With Tesevatinib on Study KD019-101 Safety of Lixivaptan in Subjects Previously Treated With Tolvaptan for Autosomal Dominant Polycystic Kidney Disease A Trial of Bardoxolone Methyl in Patients With ADPKD – FALCON Study of the Efficacy and Safety of Tesevatinib in Subjects With ADPKD Tolvaptan-Octreotide LAR Combination in ADPKD Polycystic Kidney Disease Data Repository ADPKD Patient Registry Use of Low Dose Pioglitazone to Treat Autosomal Dominant Polycystic Kidney Disease ADPKD Cohort Study Dose-finding Study of New Tolvaptan Formulation in Subjects With ADPKD Canadian Medical Assessment of JINARC™ Outcomes Registry Analysis of Clinical and Molecular Genetic Data Influencing the Evolution and Response to Therapy of ADPKD Patients (Autosomal Dominant Polycystic Kidney Disease) ADPKD Alterations in Hepatic Transporter Function Efficacy Study of Water Drinking on PKD Progression. A Study Measuring Quality of Life, Treatment Preference and Satisfaction of ADPKD Patients in Europe Somatostatin in Polycystic Kidney: a Long-term Three Year Follow up Study Open-Label Tolvaptan Study in Subjects With ADPKD Effects of Somatostatin on ADPKD Heart Clinical and Molecular Description of PKD1 and PKD2 Mutation Negative Carriers in ADPKD Diet as a Potential Treatment for Autosomal Dominant Polycystic Kidney Disease Rapamycin as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD): The Role of Biomarkers in Predicting a Response to Therapy Effect of the Aquaretic Tolvaptan on Nitric Oxide System Pilot Study of Rapamycin as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD) Outcome of Autosomal Dominant Polycystic Kidney Disease Patients on Peritoneal Dialysis: a National Retrospective Study Based on Two French Registries (the French Language Peritoneal Dialysis Registry and the French Renal Epidemiology and Information Network). Clinical Implications of DNA Analysis on ADPKD The Efficacy of Everolimus in Reducing Total Native Kidney Volume in Polycystic Kidney Disease Transplanted Recipients Subacute Effect of Tolvaptan on Total Kidney Volume in Adult Patients With Autosomal Dominant Polycystic Kidney Disease Assessment of Longitudinal Changes in Endothelial Function and Oxidative Stress in Normotensive Patients With ADPKD The Eurocyst Initiative: Building a Network of ADPKD Reference Centers Across Europe Efficacy of Tolvaptan on ADPKD Patients Pravastatin and Alkali Therapy in Patients With Autosomal Dominant Polycystic Kidney Disease A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001] A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002] Somatostatin In Patients With Autosomal Dominant Polycystic Kidney Disease And Moderate To Severe Renal Insufficiency ADPKD and Peritoneal Dialysis: How Anticipate Peritoneal Pressure? Triptolide-Containing Formulation as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD) Observational Study in Patients With Autosomal Dominant Polycystic Kidney Disease Evaluating the Safety and effectivenesS in Adult KorEaN Patients Treated With Tolvaptan for Management of Autosomal domInAnt poLycystic Kidney Disease A Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan] Efficacy, Safety and Tolerability of Everolimus in Preventing End-stage Renal Disease in Patients With Autosomal Dominant Polycystic Kidney Disease The ELiSA Study – Evaluation of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease Short-term Renal Hemodynamic Effects of Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD) Safety, Pharmacokinetics, Tolerability and Efficacy of Tolvaptan in Children and Adolescents With ADPKD (Autosomal Dominant Polycystic Kidney Disease) New Quantitive MRI Parameters in Assessing Kidneys of Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease Somatic Mutation Biorepository Sirolimus (Rapamune®) for Autosomal Dominant Polycystic Kidney Disease (ADPKD) A Clinical Trial of Water Therapy for Autosomal Dominant Polycystic Kidney Disease Adrenal Functions in Autosomal Dominant Polycystic Kidney Disease Repository Study of Autosomal Dominant Polycystic Kidney Disease Sirolimus In Autosomal Dominant Polycystic Kidney Disease And Severe Renal Insufficiency Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease The Safety and Efficacy of Catheter-based Renal Denervation Using the Vessix™ Renal Denervation System in Autosomal Dominant Polycystic Kidney Disease (ADPKD) Patients With Severe Debilitating Pain Water as Therapy in Autosomal Dominant Polycystic Kidney Disease (ADPKD) 8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD) Characterization of the Nrf2 Response in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Brief Title

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

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

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.
    

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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Total native kidney volume variation

Secondary Outcome

 Volume variation of the biggest liver cyst

Condition

Autosomal Dominant Polycystic Kidney Disease

Intervention

Everolimus

Study Arms / Comparison Groups

 Everolimus
Description:  everolimus based immunosuppression

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

3

Start Date

October 14, 2014

Completion Date

November 11, 2017

Primary Completion Date

November 11, 2017

Eligibility 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
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Hélène François, MD, PhD, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT02134899

Organization ID

P 090804

Secondary IDs

2012-004265-41

Responsible Party

Sponsor

Study Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

 Novartis

Study Sponsor

Hélène François, MD, PhD, Principal Investigator, Assistance Publique - Hôpitaux de Paris


Verification Date

December 2018