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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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This is a prospective, multicenter, comparative, parallel-group, observational study. There will be 2 cohorts according to pre-transplant dialysis modality (hemodialysis or peritoneal dialysis). In each cohort, subjects will be observed for 12 months. Approximately, 1040 subjects will be enrolled from 8 transplant centers.
Subjects will be enrolled consecutively until the number of subjects in peritoneal dialysis group has been 260. It will take 2 years. In this period, the number of subject in hemodialysis group enrolled in this study will be 780. After finishing the observation of all subjects, to balance clinical and demographic baseline characteristics between the two groups, subjects will be selected in each cohort with 1:1 matched using propensity score method. And then primary and secondary endpoints will be compared between two groups.
1. STUDY OBJECTIVES AND ENDPOINTS 1.1. Objectives
The primary objective of this study is:
• To compare the incidence of composite outcomes (delayed graft function, functional delayed graft function, primary nonfunction, biopsy-proven acute rejection) of pre-transplant dialysis modality hemodialysis versus peritoneal in recipients of first renal allografts at 1 year posttransplant.
The secondary objectives of this study are:
1.2. Endpoints
Primary endpoint:
Composite outcome including;
Delayed graft function (defined as the need for dialysis in the first week after transplantation)
Functional DGF (defined as the absence of a decrease in serum creatinine level by a minimum of 10% per day during 3 consecutive days in the first postoperative week, not including patients in whom acute rejection, calcineurin inhibitor toxicity, or both, developed within the first week
Primary nonfunction (defined as the kidney never achieving function after transplantation)
Biopsy proven acute rejection (defined as scute rejection, confirmed by allograft biopsy)
Secondary endpoints:
eGFR (calculated with abbreviated MDRD equation at Weeks 8, 16, 24, 32, 40 and 48 after renal transplant)
Hospitalization after kidney transplant (any cause, duration)
Delayed graft function, functional DGF, Primary nonfunction, biopsy proven acute rejection (definition of each endpoint is described above)
Graft loss (return to long-term dialysis)
Subject death (any cause)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemodialysis group | Hemodialysis group | ||
| peritoneal dialysis group | peritoneal dialysis group |
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| Measure | Description | Time Frame |
|---|---|---|
| composite outcomes (delayed graft function, functional delayed graft function, primary nonfunction, biopsy-proven acute rejection) |
| 1 year posttransplant |
| Measure | Description | Time Frame |
|---|---|---|
| eGFR | • eGFR (calculated with abbreviated MDRD equation at Weeks 8, 16, 24, 32, 40 and 48 after renal transplant) | 1 year |
| Hospitalization | • Hospitalization after kidney transplant (any cause, duration) |
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Inclusion Criteria:
Exclusion Criteria:
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primary care clinic
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hayoung Oh | Contact | 82-2-3410-3440 | hayoung.oh@samsung.com | |
| Munkyeong Gu, a bachelor | Contact | 82-70-7014-4152 | munkyeong.gu@samsung.com |
| Name | Affiliation | Role |
|---|---|---|
| Hayoung Oh | South Korea Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | 135-710 | South Korea |
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| 1 year |
| graft loss | • Graft loss (return to long-term dialysis) | 1 year |
| Subject death | • Subject death (any cause) | 1 year |