Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mycophenolate mofetil, Corticosteroids | Experimental |
|
|
| Corticosteroids, Mycophenolate mofetil | Active Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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)
Considering 10% drop-out rate, 76 patients will be enrolled in one arm. Totally, 152 will be enrolled. | for 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jae Won Joh, M.D., Ph.D. | Contact | 82215993114 | jw.joh@samsung.com |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daegu Catholic University Medical Center | Not yet recruiting | Daegu | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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) |
|
|
| for 1 year |
| To evaluate graft survival rates | for 1 year |
| To evaluate patient overall survial, OS | for 1 year |
| 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 |
| Samsung Medical Center | Recruiting | Seoul | 135-710 | South Korea |
|
| National Cancer Center | Not yet recruiting | Seoul | South Korea |
|
| Seoul National University | Not yet recruiting | Seoul | South Korea |
|
| Ajou University Hospital | Not yet recruiting | Suwon | South Korea |
|
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided