| Trial ID: | L1395 |
| Source ID: | NCT01609673
|
| Associated Drug: |
Everolimus
|
| Title: |
Study of Everolimus in de Novo Renal Transplant Recipients
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
End Stage Renal Failure With Renal Transplant
|
| Interventions: |
DRUG: Everolimus
|
| Outcome Measures: |
Primary: Change in estimated glomerular filtration rate (eGFR), The eGFR will be calculated by Cockcroft-Gault, CKD-EPI and MDRD equations, firstly 4-5 months after transplantation (baseline), and then 6 and 12 months after conversion to everolimus (Certican ®) and suspension of CNI, associated with Myfortic ® (mycophenolate sodium enteric-coated - MSEC)., 4-5 months after transplantation (baseline), and then 6 and 12 months after conversion to everolimus | Secondary: graft acute rejection, incidence of acute biopsy-proven rejection and clinical acute rejection (without biopsy), graft loss, death with a functioning graft, and loss of follow up at 6 and 12 months after conversion;, 6 and 12 months after conversion|Laboratory results and clinical alterations, analyzing the incidence of anemia, thrombocytopenia, leukopenia, gastrointestinal side effects, pneumonitis, oral ulcers, edema, proteinuria, and any other adverse events, as well as the need of drug withdrawal, 3, 6 and 12 months after conversion
|
| Sponsor/Collaborators: |
Sponsor: Helady Pinheiro, MD, PhD | Collaborators: Novartis
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
1
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2013-03
|
| Completion Date: |
2013-05
|
| Results First Posted: |
|
| Last Update Posted: |
2013-06-12
|
| Locations: |
Hospital São João de Deus/Fundação Geraldo Corrêa, Divinópolis, MG, 35500-227, Brazil|Hospital Márcio Cunha/Fundação São Francisco Xavier, Ipatinga, MG, 35160-158, Brazil|Fundação IMEPEN, Juiz de Fora, MG, 36036-330, Brazil|Hospital do Rim de MOntes Claros/Irmandade Nossa Senhora das Mercês, Montes Claros, MG, 39400-103, Brazil
|
| URL: |
https://clinicaltrials.gov/show/NCT01609673
|
