Clinical trial NCT02095418: Comparison of New-onset Diabetes After Transplantation Between Two Steroid Withdrawal Group With CellCept
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes
Keywords: New-onset diabetes after transplantation (NODAT)
Liver transplantation
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2014-03-24
Enrollment: 152
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: To evaluate incidence of NODAT in patients of two arms
timeFrame: for 1 year
Secondary outcomes:
measure: To evaluate incidence rate of first acute rejection
timeFrame: for 1 year
measure: To evaluate time to first acute rejection
timeFrame: for 1 year
measure: To evaluate proportion of patients experiencing treatment failure
timeFrame: for 1 year
measure: To evaluate graft survival rates
timeFrame: for 1 year
measure: To evaluate patient overall survial, OS
timeFrame: for 1 year
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: National Cancer Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
affiliation: Samsung Medical Center
name: Jae Won Joh, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Hospital
name: Kwang-Woong Lee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Center
name: Seoung Hoon Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ajou University School of Medicine
name: Hee-Jung Wang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Daegu Catholic University Medical Center
name: Dongrak Choi, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: