| Trial ID: | L0867 |
| Source ID: | NCT02328222
|
| Associated Drug: |
Esw Group
|
| Title: |
ESTEROID WITHDRAWAL STUDY, SAFETY AND EFFICACY IN RENAL TRANPLANTATION
|
| Acronym: |
ESWMEX001
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
END STAGE RENAL DISEASE
|
| Interventions: |
DRUG: ESW group
|
| Outcome Measures: |
Primary: ACUTE REJECTION FREQUENCY AND SEVERITY, ACUTE REJECTION ACCORDING TO BANFF´S CLASSIFICATION, LIMITROPHIC CHANGES (1), ACUTE REJECTION 1A (2), 1B (3), 2A (4), 2B (5); CHRONIC REJECTION (6), UP TO 1 YEAR OF FOLLOW UP | Secondary: RENAL GRAFT FUNCTION, GRAFT FUNCTION IS MEASURED BY eGFR USING MDRD-4 FORMULAE, RESULTS ARE SHOWN IN ML/MIN, UP TO 1 YEAR OF FOLLOW UP
|
| Sponsor/Collaborators: |
Sponsor: Unidad de Investigacion Medica en Enfermedades Renales
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
71
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2010-06
|
| Completion Date: |
2011-06
|
| Results First Posted: |
|
| Last Update Posted: |
2014-12-31
|
| Locations: |
Umae Hospital de Especialidades, Guadalajara, Jalisco, 44290, Mexico
|
| URL: |
https://clinicaltrials.gov/show/NCT02328222
|