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Comparison of New-onset Diabetes After Transplantation Between Two Steroid Withdrawal Group With CellCept

NCT02095418 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2014-03-24

No results posted yet for this study

Summary

With improvements in patient and graft survival, increasing attention has been placed on complications that contribute to long-term patient morbidity and mortality. New-onset diabetes after transplantation (NODAT) is a common complication of solid-organ transplantation, and is a strong predictor of graft failure and cardiovascular mortality in the transplant population. Risk factors for NODAT in transplant recipients are similar to those in non-transplant patients, but transplant-specific risk factors such as hepatitis C (HCV) infection, corticosteroids and calcineurin inhibitors play a dominant role in NODAT pathogenesis. The predominant factor for causing NODAT by corticosteroids seems to be the aggravation of insulin resistance; however several studies have displayed deleterious effects on insulin secretion and β-cells. Thus, adjusting the immunosuppressant regimen to improve glucose tolerance must be measured and defined from long term perspective.

As recipients of organ transplants survive longer, the complications of NODAT have assumed greater importance; therefore, we designed a prospective study to compare the safety and efficacy of early versus late withdrawal of corticosteroids after liver transplantation.

Conditions

Interventions

DRUG

Mycophenolate mofetil, Corticosteroids

tacrolimus (low dose, trough level of 5-12ng/ml)+Mycophenolate mofetil(500-1500mg/day\*, bid)+ Basiliximab + corticosteroids 500mg to 5mg or above (2 weeks)

DRUG

Corticosteroids, Mycophenolate mofetil

tacrolimus (low dose, trough level of 5-12ng/ml)+Mycophenolate mofetil(500-1000mg/day\*, bid)+ Basiliximab + corticosteroids 500mg to 5mg or above (3 month±2weeks)

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • Jae Won Joh, M.D., Ph.D. · Samsung Medical Center

  • Kwang-Woong Lee, M.D., Ph.D. · Seoul National University Hospital

  • Seoung Hoon Kim, M.D., Ph.D. · National Cancer Center

  • Hee-Jung Wang, M.D., Ph.D. · Ajou University School of Medicine

  • Dongrak Choi, M.D., Ph.D. · Daegu Catholic University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2018-02-28
Completion
2018-02-28

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02095418 on ClinicalTrials.gov