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

Diabetes Clinical Trial

— NODAT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02095418
• Other study ID #: ML28170
• Status: Recruiting
• Phase: N/A
• First received: March 14, 2014
• Last updated: March 20, 2014
• Start date: February 2014
• Est. completion date: February 2018

Study information

• Verified date: March 2014
• Source: Samsung Medical Center
• Contact: Jae Won Joh, M.D., Ph.D.
• Phone: 82215993114
• Email: jw.joh[@]samsung.com
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 152
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes

Intervention

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)
• 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)

Locations

Country	Name	City	State
Korea, Republic of	Daegu Catholic University Medical Center	Daegu
Korea, Republic of	National Cancer Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University	Seoul
Korea, Republic of	Ajou University Hospital	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate incidence of NODAT in patients of two arms	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); Incidence of NODAT in ref. : (9.9%); 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	No
Secondary	To evaluate incidence rate of first acute rejection		for 1 year	No
Secondary	To evaluate time to first acute rejection		for 1 year	No
Secondary	To evaluate proportion of patients experiencing treatment failure		for 1 year	No
Secondary	To evaluate graft survival rates		for 1 year	No
Secondary	To evaluate patient overall survial, OS		for 1 year	No