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ESTEROID WITHDRAWAL STUDY, SAFETY AND EFFICACY IN RENAL TRANPLANTATION (ESWMEX001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02328222
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : December 31, 2014
Sponsor:
Information provided by (Responsible Party):
Unidad de Investigacion Medica en Enfermedades Renales

Brief Summary:

BACKGROUND: Non-steroid maintenance immunosuppression after transplantation can improve long-term lipid and hemodynamic profiles without severe acute rejection (AR) events that alter graft function or survival. Our objective was to evaluate the effects of early steroid withdrawal (ESW) on the frequency and severity of AR using an immunosuppressive scheme consisting of mycophenolate (MMF) and tacrolimus (TAC) in combination with an induction treatment with basiliximab.

METHODS: A randomized clinical trial was performed on first renal transplant recipients. In the ESW group, patients were selected for corticosteroid treatment withdrawal on the fifth day post-transplantation. In the Control group, patients continued steroid treatment.


Condition or disease Intervention/treatment Phase
END STAGE RENAL DISEASE Drug: ESW group Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PHASE 4, STUDY OF THE EFFECT OF EARLY STEROID WITHDRAWAL IN RENAL TRANSPLANT RECEPIENTS OF A LIVING-RELATED DONOR
Study Start Date : June 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Arm Intervention/treatment
No Intervention: CONTROL GROUP
CORTICOSTEDORID TREATMENT WAS AS FOLLOWS: day zero post-transplantation (DP 0), 500 mg/day of MPD; (DP 1), 250 mg MPD; (DP 2), 125 mg MPD; (DP 3), 60 mg MPD; (DP 4), 30 mg MPD; and (DP 5), PREDNISONE AS DOSES 1 MG/KG (1 MONTH) AND A REDUCTION TO ACHIEVE 0.1 MG/KG IN THE 3rd MONTH.
Experimental: ESW group
CORTICOSTEDORID TREATMENT WAS AS FOLLOWS: day zero post-transplantation (DP 0), 500 mg/day of MPD; (DP 1), 250 mg MPD; (DP 2), 125 mg MPD; (DP 3), 60 mg MPD; (DP 4), 30 mg MPD; and (DP 5), PREDNISONE AS DOSES 1 MG/KG (1 MONTH) AND A REDUCTION TO ACHIEVE 0.1 MG/KG IN THE 3rd MONTH.
Drug: ESW group
CORTICOSTEDORID TREATMENT WAS AS FOLLOWS: day zero post-transplantation (DP 0), 500 mg/day of MPD; (DP 1), 250 mg MPD; (DP 2), 125 mg MPD; (DP 3), 60 mg MPD; (DP 4), 30 mg MPD; and (DP 5), PREDNISONE AS DOSES 1 MG/KG (1 MONTH) AND A REDUCTION TO ACHIEVE 0.1 MG/KG IN THE 3rd MONTH.
Other Names:
  • STEROID AVOIDANCE
  • STEROID WITHDRAWAL




Primary Outcome Measures :
  1. ACUTE REJECTION FREQUENCY AND SEVERITY [ Time Frame: UP TO 1 YEAR OF FOLLOW UP ]
    ACUTE REJECTION ACCORDING TO BANFF´S CLASSIFICATION, LIMITROPHIC CHANGES (1), ACUTE REJECTION 1A (2), 1B (3), 2A (4), 2B (5); CHRONIC REJECTION (6)


Secondary Outcome Measures :
  1. RENAL GRAFT FUNCTION [ Time Frame: UP TO 1 YEAR OF FOLLOW UP ]
    GRAFT FUNCTION IS MEASURED BY eGFR USING MDRD-4 FORMULAE, RESULTS ARE SHOWN IN ML/MIN



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Over 18 years of age
  • Panel reactive antibody (PRA) class I and II HLA <20%.
  • Any gender
  • Living donor

Exclusion Criteria:

  • Patients with co-morbidities that required the use of steroid,
  • Delayed graft function or AR during the 5 days post-transplantation,
  • Along with patients that decided to leave the study.
  • Multiorganic recipients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328222


Locations
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Mexico
Umae Hospital de Especialidades
Guadalajara, Jalisco, Mexico, 44290
Sponsors and Collaborators
Unidad de Investigacion Medica en Enfermedades Renales
Investigators
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Study Director: ALFONSO M CUETO-MANZANO, PhD Instituto Mexicano del Seguro Social
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Responsible Party: Unidad de Investigacion Medica en Enfermedades Renales
ClinicalTrials.gov Identifier: NCT02328222    
Other Study ID Numbers: SWKT
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: December 31, 2014
Last Verified: December 2014
Keywords provided by Unidad de Investigacion Medica en Enfermedades Renales:
Early steroid withdrawal
Acute allograft rejection
Mycophenolate
Tacrolimus
Basiliximab
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency