Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001385-18 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Novartis | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main objective of this protocol is to compare the impact on renal function of two different immunosuppressive regimens in patients with de novo renal transplant.
Renal function will be accurately evaluated by measuring the clearance of iohexol.
The protocol will also evaluate the efficacy and safety in a short term of these two different immunosuppressive regimens.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyclosporin + Mycophenolate mofetil | Active Comparator |
| |
| Everolimus + mycophenolate mofetil | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cyclosporin + mycophenolate mofetil | Drug | antirejection drug, renal transplantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of glomerular filtration rate measured by clearance of iohexol | one year |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nephrology department, Hospital University of Amiens | Amiens | 80000 | France | |||
| Nephrology Department, University Hospital of Montpellier |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| everolimus + mycophenolate mofetil | Drug | antirejection drug, renal transplantation |
|
| Montpellier |
| 34285 |
| France |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| D009173 | Mycophenolic Acid |
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
Not provided
Not provided