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

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.

Study Overview

• Status: Recruiting
• Conditions: Kidney Transplant Rejection; Skin Graft
• Intervention / Treatment: Procedure: Skin allotransplantation

• Study Type: Observational
• Enrollment (Estimated): 24

Contacts and Locations

• Study Contact: Name: Chenggang Yi, M.D.; Phone Number: +8613567113534; Email: cwar@163.com
• Study Contact Backup: Name: Songxue Guo, M.D.; Phone Number: +8618506857388; Email: guosongxue@zju.edu.cn

Study Locations

• China
  • Shannxi
    • Xi'an, Shannxi, China, 400041
      • Recruiting
      • Xijing Hospital, Ari Force Medical University
      • Contact: Geng Zhang, M.D.
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • First Affiliated Hospital, School of Medicine, Zhejiang University
      • Contact: Jinghong Xu, M.D.
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
      • Contact: Weiqiang Tan, M.D.; Phone Number: +8613666658609; Email: tanweixxxx@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

1. Patients with end-stage renal disease undergoing renal transplantation;
2. 18-60 years old;
3. 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);
4. The participants had good compliance, volunteered to participate in the test and signed the informed consent form.

Exclusion Criteria:

1. Untreated or disseminated malignant tumor;
2. Active period of infectious diseases;
3. Serious cardiovascular disease occurred recently;
4. Combined with other important organ failure;
5. History of mental illness or cognitive impairment;

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Kidney and skin transplataiton	Procedure: Skin allotransplantation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Renal ultrasound diagnosis	Renal ultrasound diagnosis	Through study completion, an average of 1 year
Complications	Complications assessment	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Zhejiang University; Sir Run Run Shaw Hospital; Xijing Hospital, Air Force Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 27, 2022
• First Submitted That Met QC Criteria: October 27, 2022
• First Posted (Actual): October 31, 2022

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2023-0719

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No