The Effects of Pre-transplant Dialysis Modality on Post-transplant Events
The Effects of Pre-transplant Dialysis Modality on Post-transplant Events
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:

 -  To compare the incidence of delayed graft function and functional delayed graft function
 of pre-transplant dialysis modality hemodialysis versus peritoneal in recipients of
 first renal allografts at 1 year posttransplant;

 -  To compare the incidence of composite outcomes biopsy-proven acute rejection of
 pre-transplant dialysis modality hemodialysis versus peritoneal in recipients of first
 renal allografts at 1 year posttransplant;

 -  To compare the incidence of primary nonfunction of pre-transplant dialysis modality
 hemodialysis versus peritoneal in recipients of first renal allografts at 1 year
 posttransplant;

 -  To evaluate the effect of hemodialysis or peritoneal dialysis on graft function in terms
 of longitudinal change of eGFR calculated with abbreviated MDRD equation at Weeks 8, 16,
 24, 32, 40, and 48 after renal transplant;

 -  To compare the incidence and the duration of hospitalization after kidney
 transplantation of pre-transplant dialysis modality hemodialysis versus peritoneal in
 recipients of first renal allografts at 1 year posttransplant;

 -  To compare the graft loss and subject death rate of pre-transplant dialysis modality
 hemodialysis versus peritoneal in recipients of first renal allografts at 1 year
 posttransplant.

 1.2. Endpoints

 Primary endpoint:

 -  Composite outcome including;

 1. Delayed graft function (defined as the need for dialysis in the first week after
 transplantation)

 2. 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

 3. Primary nonfunction (defined as the kidney never achieving function after
 transplantation)

 4. 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)
Inclusion Criteria:

 1. Subjects must have end-stage renal disease, have been on one renal replacement therapy
 (hemodialysis or peritoneal dialysis) for > 6 months ( Who had been on hemodialysis
 for at least 6 months before renal transplant for the hemodialysis group; Who had been
 on peritoneal dialysis for at least 6 months before renal transplant for the
 peritoneal dialysis group ), and are scheduled to receive a first kidney transplant
 from a deceased donor, a living-related donor, or a living-unrelated donor.

 2. Between the ages of 20 and 70 years, inclusive.

 3. Either female or male adults

 4. Subjects must be willing and able to provide written personal information consent with
 evidence of a personally signed and dated personal information consent document
 indicating that the subject (or a legally acceptable representative) has been informed
 of all pertinent aspects of the study.

 Exclusion Criteria:

 1. Subjects who had combined dialysis (hemodialysis + peritoneal dialysis
 simultaneously).

 2. Subjects who are recipients for multiple organ transplant.

 3. Subjects scheduled for non-heart beating donor transplantation.

 4. Subjects scheduled for transplantation using desensitization (plasmapheresis +
 Rituximab) process.

 5. Subjects with evidence of active infection.

 6. Women of childbearing potential who are either pregnant, lactating, planning to become
 pregnant in the next 12 months. Women of childbearing potential must be willing to
 agree to contraceptive practices.