NCT02328222

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2014

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 31, 2014

Completed
Last Updated

December 31, 2014

Status Verified

December 1, 2014

Enrollment Period

1 year

First QC Date

July 15, 2014

Last Update Submit

December 26, 2014

Conditions

END STAGE RENAL DISEASE

Keywords

Early steroid withdrawalAcute allograft rejectionMycophenolateTacrolimusBasiliximab

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • RENAL GRAFT FUNCTION

    UP TO 1 YEAR OF FOLLOW UP

Study Arms (2)

CONTROL GROUP

NO INTERVENTION

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.

ESW group

EXPERIMENTAL

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

Interventions

ESW groupDRUG

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.

Also known as: STEROID AVOIDANCE, STEROID WITHDRAWAL
ESW group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umae Hospital de Especialidades

Guadalajara, Jalisco, 44290, Mexico

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • ALFONSO M CUETO-MANZANO, PhD

    Instituto Mexicano del Seguro Social

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2014

First Posted

December 31, 2014

Study Start

June 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

December 31, 2014

Record last verified: 2014-12

Locations

ME(1)