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

NCT ID: NCT02095418

Last Updated: 2014-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2018-02-28

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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 It will be tapered at least 5mg for 14days and withdrawn

Group Type: EXPERIMENTAL

Corticosteroids, Mycophenolate mofetil

Intervention Type: DRUG

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)

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 It will be tapered at least 5mg for 3months(± 2 weeks) and withdrawn.

Group Type: ACTIVE_COMPARATOR

Mycophenolate mofetil, Corticosteroids

Intervention Type: DRUG

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

Interventions

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)

Intervention Type: 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)

Intervention Type: DRUG

Other Intervention Names

CellCept, Methylon; Methylon, CellCept

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

JAE WON JOH

Coordinating Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jae Won Joh, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Kwang-Woong Lee, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Seoung Hoon Kim, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center

Hee-Jung Wang, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Ajou University School of Medicine

Dongrak Choi, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Daegu Catholic University Medical Center

Locations

Daegu Catholic University Medical Center

Daegu, , South Korea

Site Status: NOT_YET_RECRUITING

Samsung Medical Center

Seoul, , South Korea

Site Status: RECRUITING

National Cancer Center

Seoul, , South Korea

Site Status: NOT_YET_RECRUITING

Seoul National University

Seoul, , South Korea

Site Status: NOT_YET_RECRUITING

Ajou University Hospital

Suwon, , South Korea

Site Status: NOT_YET_RECRUITING

Countries

South Korea

Central Contacts

Jae Won Joh, M.D., Ph.D.

Role: CONTACT

jw.joh@samsung.com

82215993114

Facility Contacts

Dongrak Choi, M.D., Ph.D.

Role: primary

dnchoi@cu.ac.kr

82-10-9041-0742

Jae Won Joh, M.D., Ph.D.

Role: primary

jw.joh@Samsung.com

82 2 1599 3114

Seoung Hoon Kim, M.D., Ph.D.

Role: primary

kshlj@hanmail.net

82-10-2907-3766

Kwang-Woong Lee, M.D., Ph.D.

Role: primary

kwleegs@gmail.com

82-2-2072-2511

Hee-Jung Wang, M.D., Ph.D.

Role: primary

wanghj@ajou.ac.kr

82-31-219-5204

Other Identifiers

ML28170

Identifier Type: -

Identifier Source: org_study_id