The Effects of Pre-transplant Dialysis Modality on Post-transplant Events (PDMP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2012 by Samsung Medical Center
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Ha Young Oh, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01513707
First received: January 16, 2012
Last updated: January 19, 2012
Last verified: January 2012
  Purpose

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.


Condition
Delayed Function of Renal Transplant
Primary Nonfunction of Renal Transplant
Acute Rejection of Renal Transplant

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effects of Pre-transplant Dialysis Modality on Post-transplant Events

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • composite outcomes (delayed graft function, functional delayed graft function, primary nonfunction, biopsy-proven acute rejection) [ Time Frame: 1 year posttransplant ] [ Designated as safety issue: No ]
    1. Delayed graft function
    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
    4. Biopsy proven acute rejection


Secondary Outcome Measures:
  • eGFR [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    • eGFR (calculated with abbreviated MDRD equation at Weeks 8, 16, 24, 32, 40 and 48 after renal transplant)

  • Hospitalization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    • Hospitalization after kidney transplant (any cause, duration)

  • graft loss [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    • Graft loss (return to long-term dialysis)

  • Subject death [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    • Subject death (any cause)


Estimated Enrollment: 1040
Study Start Date: December 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Hemodialysis group
Hemodialysis group
peritoneal dialysis group
peritoneal dialysis group

Detailed Description:

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)
  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

primary care clinic

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01513707

Contacts
Contact: Hayoung Oh 82-2-3410-3440 hayoung.oh@samsung.com
Contact: Eunkyoung Jung, a bachelor 82-70-7014-4164 gait77.jung@samsung.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Hayoung Oh    82-2-3410-3440    hayoung.oh@samsung.com   
Contact: Eunkyoung Jung, a bachelor    82-70-7014-4164    gait77.jung@samsung.com   
Principal Investigator: Hayoung Oh         
Sponsors and Collaborators
Ha Young Oh
Baxter Healthcare Corporation
Investigators
Principal Investigator: Hayoung Oh South Korea Samsung Medical Center
  More Information

No publications provided

Responsible Party: Ha Young Oh, professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01513707     History of Changes
Other Study ID Numbers: 2011-12-005
Study First Received: January 16, 2012
Last Updated: January 19, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
kidney transplantation
hemodialysis
peritoneal dialysis

ClinicalTrials.gov processed this record on July 22, 2014