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

March 20, 2014 updated by: JAE WON JOH, Samsung Medical Center

Open Label, Multicenter Randomized Control Study to Investigate the Incidence of NODAT (New-Onset Diabetes After Transplantation), Safety and Efficacy of Corticosteroids Early Withdrawal in Liver Transplanted Recipients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

152

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of
        • Not yet recruiting
        • Daegu Catholic University Medical Center
        • Contact:
          • Dongrak Choi, M.D., Ph.D.
          • Phone Number: 82-10-9041-0742
          • Email: dnchoi@cu.ac.kr
      • Seoul, Korea, Republic of, 135-710
        • Recruiting
        • Samsung Medical Center
        • Contact:
      • Seoul, Korea, Republic of
        • Not yet recruiting
        • National Cancer Center
        • Contact:
          • Seoung Hoon Kim, M.D., Ph.D.
          • Phone Number: 82-10-2907-3766
          • Email: kshlj@hanmail.net
      • Seoul, Korea, Republic of
        • Not yet recruiting
        • Seoul National University
        • Contact:
      • Suwon, Korea, Republic of
        • Not yet recruiting
        • Ajou University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1.Male or female patients between 20-70 years 2.De novo patients 3.Recipients from living or cadaveric donors 4.Single organ recipient (liver only) 5.White Blood Cell(WBC) ≥ 3,000uL 6.Women of childbearing potential had to have a negative serum or urine pregnancy test within 1 week prior to beginning study treatment. Effective contraception has to be used before beginning therapy, during therapy and for 6 weeks following discontinuation of therapy 7.Patients co-operative and able to complete all the assessment procedures. 8.Patients provided written informed consent

Exclusion Criteria:

  1. Patients who receive immunosuppressive therapy (except steroid treatment) within the preceding 28 days.
  2. Incompatible A,B, and O blood group system.
  3. Active infection
  4. Patients whose laboratory results reveal severe anaemia (as defined by a haemoglobin value < 9 g/dL for adults receiving erythropoietin, 6.5 g/dL for adults not receiving erythropoietin, leukopenia (as defined by a white blood cell [WBC] value of <1500/mm3) or thrombocytopenia (as defined by a platelet count of <30,000/mm3).
  5. Mandatory intake of prohibited drugs or if it is probable that the patient would require treatment with such drugs after transplant
  6. Patient is allergic or intolerant to excipients, steroids, Mycophenolate mofetil(MMF), tacrolimus or basiliximab.
  7. Patients with any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication with the investigator or with study procedures.
  8. The receipt of a new investigational drug within the previous 3 months
  9. Pregnant or lactating females.
  10. Women of child-bearing potential not willing to use a reliable form of contraception.
  11. Previous organ transplantation
  12. Patients who have diabetes mellitus prior to transplantation
  13. Patients who have cancer other than liver cancer
  14. Patients who have HGPRT(hypoxanthine quinine phosphoribosyl transferase) deficiency, Lesch-Nyhan syndrome, Kelly-Seegmiller syndrome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Mycophenolate mofetil, Corticosteroids
  • Mycophenolate mofetil: 500-1500mg/day, bid, PO
  • Corticosteroids: 500mg for the first dosage. It will be tapered at least 5mg for 14days and withdrawn
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)
Other Names:
  • Methylon, CellCept
ACTIVE_COMPARATOR: Corticosteroids, Mycophenolate mofetil
  • Mycophenolate mofetil: 500-1000mg/day, bid, PO
  • Corticosteroids 500mg for the first dosage. It will be tapered at least 5mg for 3months(± 2 weeks) and withdrawn.
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)
Other Names:
  • CellCept, Methylon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate incidence of NODAT in patients of two arms
Time Frame: for 1 year

NODAT will be defined as consecutively FPG ≥126mg/dl in two different days or PPG 2hr ≥200mg/dl Ref. Steroid Withdrawal in Adult Liver Transplantation: Occurrence at a Single Center. Transplantation Proceedings, 2010; 42: 4132-4136)

  1. Incidence of NODAT in ref. : (9.9%)
  2. 95% Confidence Interval(CI): (6%)

Considering 10% drop-out rate, 76 patients will be enrolled in one arm. Totally, 152 will be enrolled.
for 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate incidence rate of first acute rejection
Time Frame: for 1 year
for 1 year
To evaluate time to first acute rejection
Time Frame: for 1 year
for 1 year
To evaluate proportion of patients experiencing treatment failure
Time Frame: for 1 year
for 1 year
To evaluate graft survival rates
Time Frame: for 1 year
for 1 year
To evaluate patient overall survial, OS
Time Frame: for 1 year
for 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Jae Won Joh, M.D., Ph.D., Samsung Medical Center
  • Principal Investigator: Kwang-Woong Lee, M.D., Ph.D., Seoul National University Hospital
  • Principal Investigator: Seoung Hoon Kim, M.D., Ph.D., National Cancer Center
  • Principal Investigator: Hee-Jung Wang, M.D., Ph.D., Ajou University School of Medicine
  • Principal Investigator: Dongrak Choi, M.D., Ph.D., Daegu Catholic University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (ANTICIPATED)

February 1, 2018

Study Completion (ANTICIPATED)

February 1, 2018

Study Registration Dates

First Submitted

March 14, 2014

First Submitted That Met QC Criteria

March 20, 2014

First Posted (ESTIMATE)

March 24, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

March 24, 2014

Last Update Submitted That Met QC Criteria

March 20, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML28170

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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