Multi Center Observation of Sentinel Skin Graft for Detecting Acute Rejection After Renal Transplantation
Multi Center Clinical Observation of Sentinel Skin Graft From the Same Donor Source for Detecting Acute Rejection After Renal Transplantation
1 other identifier
observational
24
1 country
3
Brief Summary
The purpose of this study was to explore the accuracy of sentinel skin grafts from the same donor source in diagnosing renal allograft rejection, and to provide new ideas and options for the later clinical diagnosis of renal allograft rejection. Further, try to provide timing guidance for early immunization intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2024
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2022
CompletedFirst Posted
Study publicly available on registry
October 31, 2022
CompletedStudy Start
First participant enrolled
January 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
November 28, 2023
October 1, 2023
2.5 years
October 27, 2022
November 27, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
2017 Banff Kidney Transplantation Rejection Rating
A rating evaluation on kidney rejection
Through study completion, an average of 1 year
2007-edition Banff skin containing allogeneic composite histopathological diagnosis grading
Skin histopathological diagnosis
Through study completion, an average of 1 year
Renal function testing
Blood Cr and Bun testing
Through study completion, an average of 1 year
Secondary Outcomes (2)
Renal ultrasound diagnosis
Through study completion, an average of 1 year
Complications
Through study completion, an average of 1 year
Study Arms (1)
Kidney and skin transplataiton
Interventions
Sentinel skin grafts from the same donor source will be carried on in the meantime of kidney transplantation for assisting to detect acute renal rejection.
Eligibility Criteria
This study is an exploratory study. In the early stage, there is no relevant study on the accuracy of sentinel skin flap monitoring renal rejection, and there is a lack of corresponding sensitivity and specificity indicators. Considering that the incidence of acute rejection in the first year after transplantation is 15-30%, it is estimated that 20 cases will be included. Because the experimental data may be lost, or the participants may withdraw from the trial or lose the interview, the sample size will be increased by 20%, and finally 24 cases will be included in the trial.
You may qualify if:
- Patients with end-stage renal disease undergoing renal transplantation;
- years old;
- Postoperative follow-up points are complete (visit the hospital every week in the first month after surgery, every two weeks in 2-3 months, every four to six months, and every three months in 7-12 months. Follow up at any time when skin rejection is observed. The follow-up time may be adjusted when the condition changes);
- The participants had good compliance, volunteered to participate in the test and signed the informed consent form.
You may not qualify if:
- Untreated or disseminated malignant tumor;
- Active period of infectious diseases;
- Serious cardiovascular disease occurred recently;
- Combined with other important organ failure;
- History of mental illness or cognitive impairment;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Xijing Hospital, Ari Force Medical University
Xi'an, Shannxi, 400041, China
First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000, China
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000, China
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2022
First Posted
October 31, 2022
Study Start
January 1, 2024
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
November 28, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share