Delayed Function of Renal TransplantPDMPNCT01513707
The Effects of Pre-transplant Dialysis Modality on Post-transplant Events
An observational study of Delayed Function of Renal Transplant and Primary Nonfunction of Renal Transplant, run by Ha Young Oh at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Delayed Function of Renal Transplant, Primary Nonfunction of Renal Transplant, Acute Rejection of Renal Transplant
- How many people
- 1,040 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Dec 2011to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primary care clinic
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 135-710
Hayoung Oh, 82-2-3410-3440, hayoung.oh@samsung.com
Munkyeong Gu, bachelor's degree, 82-70-7014-4152, munkyeong.gu@samsung.com
About this study
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.
Read the detailed description
- 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;
- 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)
- Conditions
- Delayed Function of Renal Transplant, Primary Nonfunction of Renal Transplant, Acute Rejection of Renal Transplant
- Keywords
- kidney transplantation, hemodialysis, peritoneal dialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis group | Hemodialysis group | |
| peritoneal dialysis group | peritoneal dialysis group |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite outcomes (delayed graft function, functional delayed graft function, primary nonfunction, biopsy-proven acute rejection)
- Delayed graft function
- 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
- Biopsy proven acute rejection
Measured: 1 year posttransplant
Secondary outcomes (4)
eGFR
- eGFR (calculated with abbreviated MDRD equation at Weeks 8, 16, 24, 32, 40 and 48 after renal transplant)
Measured: 1 year
Hospitalization
- Hospitalization after kidney transplant (any cause, duration)
Measured: 1 year
graft loss
- Graft loss (return to long-term dialysis)
Measured: 1 year
Subject death
- Subject death (any cause)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study start22 Dec 2011
- Primary completionSep 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Function of Renal TransplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,040 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ha Young Oh
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor-investigator, Ha Young Oh, Samsung Medical Center
- Investigators
- Hayoung Oh, Principal investigator, South Korea Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01513707
- Sponsor's protocol ID
- 2011-12-005
- Acronym
- PDMP
- Status last verified
- Apr 2017
- First submitted
- 16 Jan 2012
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Pre-transplant Dialysis Modality on Post-transplant Events
- ClinicalTrials.gov ID
- NCT01513707
- Acronym / sponsor ID
- PDMP / 2011-12-005
- Conditions
- Delayed Function of Renal Transplant, Primary Nonfunction of Renal Transplant, Acute Rejection of Renal Transplant
- Keywords
- kidney transplantation, hemodialysis, peritoneal dialysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,040 participants (estimated)
- Lead sponsor
- Ha Young OhUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- 22 Dec 2011 (actual)
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 20 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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;
- 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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis group | – | –Hemodialysis group |
| peritoneal dialysis group | – | –peritoneal dialysis group |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
composite outcomes (delayed graft function, functional delayed graft function, primary nonfunction, biopsy-proven acute rejection)
Time frame: 1 year posttransplant
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
4 secondary outcomes
eGFR
Time frame: 1 year
Hospitalization
Time frame: 1 year
graft loss
Time frame: 1 year
Subject death
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hayoung Oh principal investigator
South Korea Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delayed Function of Renal Transplant and Primary Nonfunction of Renal Transplant, run by Ha Young Oh at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hayoung Oh (82-2-3410-3440, hayoung.oh@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composite outcomes (delayed graft function, functional delayed graft function, primary nonfunction, biopsy-proven acute rejection) (time frame: 1 year posttransplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2017.