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

Not Applicable

• Conditions: Diabetes
• Interventions: Drug: Corticosteroids, Mycophenolate mofetil; Drug: Mycophenolate mofetil, Corticosteroids

• Registration Number: NCT02095418
• Lead Sponsor: Samsung Medical Center

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-02
• Status Verified: 2014-03
• Study First Submitted: 2014-03-14
• Study First Submitted QC: 2014-03-20
• Last Update Submitted: 2014-03-20
• Study First Posted: 2014-03-24
• Last Update Posted: 2014-03-24
• Primary Completion: 2018-02
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 152

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mycophenolate mofetil, Corticosteroids	Corticosteroids, Mycophenolate mofetil	* Mycophenolate mofetil: 500-1500mg/day, bid, PO * Corticosteroids: 500mg for the first dosage. It will be tapered at least 5mg for 14days and withdrawn
Corticosteroids, Mycophenolate mofetil	Mycophenolate mofetil, Corticosteroids	* 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.

Primary Outcome Measures

Name	Time	Method
To evaluate incidence of NODAT in patients of two arms	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.

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Seoul National University; 🇰🇷 Seoul, Korea, Republic of

Daegu Catholic University Medical Center; 🇰🇷 Daegu, Korea, Republic of

National Cancer Center; 🇰🇷 Seoul, Korea, Republic of

Ajou University Hospital; 🇰🇷 Suwon, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of