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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004265-41 | EudraCT Number |
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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Everolimus | Experimental | everolimus based immunosuppression |
|
| Calcineurin | Active Comparator | Calcineurin inhibitors maintenance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus | Drug | Change from a calcineurin inhibitors-based immunosuppression to an everolimus-based immunosuppression |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total native kidney volume variation | measurements of total native kidney volume with a MRI | 24 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Volume variation of the biggest liver cyst | Measurements of the biggest liver cyst volume with a MRI | 24 months after randomization |
| Interstitial Fibrosis/Tubular Atrophy variation | IF/TA quantification using Banff criteria during a kidney biopsy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hélène François, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bicêtre Hospital | Le Kremlin-Bicêtre | 94275 | France |
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| Calcineurin inhibitors maintenance | Drug | Usual treatment |
|
|
| 24 months after randomization |
| % interstitial fibrosis using Red Sirius staining | % fibrosis quantified using a morphometry software | 24 months after randomization |
| Calculated Estimated Glomerular Filtration rate | calculated estimated GFR | At baseline, 1 month, 6 months, 12 months, 18 and 24 months |
| Measured Glomerular Filtration rate | measured GFR | At baseline and 24 months |
| Proteinuria | Measurement | At baseline, 1 month, 6 months, 12 months, 18 and 24 months |
| systolic and diastolic blood pressure | Clinic measurement | At baseline, 1 month, 6 months, 12 months, 18 and 24 months |
| Occurrence of diabetes or hyperlipidemia | Measurements | up to 24 months |
| Occurrence of neoplasia | Medical chart reporting | up to 24 months |
| Development of HLA Donor Specific Antibody (DSA) | V0, 1 year and 2 years after randomization | At baseline, 1 month, 6 months, 12 months, 18 and 24 months |
| ID | Term |
|---|---|
| D016891 | Polycystic Kidney, Autosomal Dominant |
| D003560 | Cysts |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D007690 | Polycystic Kidney Diseases |
| D052177 | Kidney Diseases, Cystic |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000072661 | Ciliopathies |
| D030342 | Genetic Diseases, Inborn |
| D009369 | Neoplasms |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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