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

NCT02095418 | Unknown

• 1 other identifier: ML28170
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 5

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

Keywords

New-onset diabetes after transplantation (NODAT); Liver transplantation

Outcome Measures

Primary Outcomes (1)

• 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) 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 Outcomes (5)

• To evaluate incidence rate of first acute rejection

  for 1 year

• 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

Study Arms (2)

Mycophenolate mofetil, Corticosteroids

EXPERIMENTAL

* 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

Corticosteroids, Mycophenolate mofetil

ACTIVE COMPARATOR

* 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

Interventions

Mycophenolate mofetil, Corticosteroids 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)

Also known as: CellCept, Methylon

Corticosteroids, Mycophenolate mofetil

Corticosteroids, Mycophenolate mofetil 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)

Also known as: Methylon, CellCept

Mycophenolate mofetil, Corticosteroids

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who receive immunosuppressive therapy (except steroid treatment) within the preceding 28 days.
• Incompatible A,B, and O blood group system.
• Active infection
• 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).
• Mandatory intake of prohibited drugs or if it is probable that the patient would require treatment with such drugs after transplant
• Patient is allergic or intolerant to excipients, steroids, Mycophenolate mofetil(MMF), tacrolimus or basiliximab.
• 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.
• The receipt of a new investigational drug within the previous 3 months
• Pregnant or lactating females.
• Women of child-bearing potential not willing to use a reliable form of contraception.
• Previous organ transplantation
• Patients who have diabetes mellitus prior to transplantation
• Patients who have cancer other than liver cancer
• Patients who have HGPRT(hypoxanthine quinine phosphoribosyl transferase) deficiency, Lesch-Nyhan syndrome, Kelly-Seegmiller syndrome

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (5)

Daegu Catholic University Medical Center

Daegu, South Korea

NOT YET RECRUITING

Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

National Cancer Center

Seoul, South Korea

NOT YET RECRUITING

Seoul National University

Seoul, South Korea

NOT YET RECRUITING

Ajou University Hospital

Suwon, South Korea

NOT YET RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Mycophenolic Acid; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

82215993114; jw.joh@samsung.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating Investigator

Study Record Dates

• First Submitted: March 14, 2014
• First Posted: March 24, 2014
• Study Start: February 1, 2014
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: March 24, 2014

Record last verified: 2014-03

Locations

KR (5)