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

NCT01513707 | Unknown

• 1 other identifier: 2011-12-005
• Study Type: observational
• Target: 1,040
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

kidney transplantation; hemodialysis; peritoneal dialysis

Outcome Measures

Primary Outcomes (1)

• composite outcomes (delayed graft function, functional delayed graft function, primary nonfunction, biopsy-proven acute rejection)

  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

  1 year posttransplant

Secondary Outcomes (4)

• eGFR

  1 year

• Hospitalization

  1 year

• graft loss

  1 year

• Subject death

  1 year

Study Arms (2)

Hemodialysis group

Hemodialysis group

peritoneal dialysis group

peritoneal dialysis group

Eligibility Criteria

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

Study Population

primary care clinic

You may qualify if:

• 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.
• Between the ages of 20 and 70 years, inclusive.
• Either female or male adults
• 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.

You may not qualify if:

• Subjects who had combined dialysis (hemodialysis + peritoneal dialysis simultaneously).
• Subjects who are recipients for multiple organ transplant.
• Subjects scheduled for non-heart beating donor transplantation.
• Subjects scheduled for transplantation using desensitization (plasmapheresis + Rituximab) process.
• Subjects with evidence of active infection.
• 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.

Sponsors & Collaborators

• Ha Young Oh: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

Study Officials

• Hayoung Oh

  South Korea Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hayoung Oh

CONTACT

82-2-3410-3440; hayoung.oh@samsung.com

Munkyeong Gu, a bachelor

CONTACT

82-70-7014-4152; munkyeong.gu@samsung.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 16, 2012
• First Posted: January 20, 2012
• Study Start: December 22, 2011
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 27, 2017

Record last verified: 2017-04

Locations

KR (1)