Actively Recruiting

Age: 18Years - 60Years
All Genders
ID05600634

Multi Center Clinical Observation of Sentinel Skin Graft From the Same Donor Source for Detecting Acute Rejection After Renal Transplantation

Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2023-11-28

24

Participants Needed

3

Research Sites

26 weeks

Total Duration

On this page

Sponsors

S

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead Sponsor

Z

Zhejiang University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are exploring the use of sentinel skin grafts taken from the same donor to detect acute rejection after kidney transplantation. This observational study aims to improve the early diagnosis of kidney transplant rejection and provide timing guidance for early immune intervention. It is sponsored by the Second Affiliated Hospital, School of Medicine, Zhejiang University and focuses on patients aged 18 to 60 with end-stage renal disease undergoing kidney transplantation. The study involves performing sentinel skin grafts alongside kidney transplantation from the same donor source. These skin grafts will be monitored to assist in detecting acute rejection of the kidney transplant. Participants will be followed regularly after surgery, with visits weekly in the first month, then every two weeks during months 2 to 3, every four to six months later, and every three months during months 7 to 12. Additional follow-up may occur if signs of skin rejection appear. During the study, researchers will assess kidney transplant rejection using established Banff criteria for kidney and skin tissue, kidney function tests, renal ultrasound, and record any complications. Follow-up will last approximately one year. Participants will undergo regular hospital visits and evaluations to monitor transplant status and overall health as part of this clinical observation.

CONDITIONS

Brief Title

Multi Center Observation of Sentinel Skin Graft for Detecting Acute Rejection After Renal Transplantation

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with end-stage renal disease undergoing renal transplantation
  • Aged between 18 and 60 years old
  • Willing and able to attend postoperative follow-up visits regularly as scheduled
  • Good compliance with study procedures and signed informed consent
Not Eligible

You will not qualify if you...

  • Untreated or widespread malignant tumor
  • Active infectious diseases
  • Recent serious cardiovascular disease
  • Failure of other important organs
  • History of mental illness or cognitive impairment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

Duration - Around the time of kidney transplantation

Participants receive sentinel skin grafts from the same donor source alongside kidney transplantation to assist in detecting acute renal rejection.

Long-term Monitoring

Duration - Approximately 1 year

Participants are monitored for acute rejection and renal function through various tests and assessments over approximately 1 year following transplantation.

Regular follow-up visits as scheduled postoperatively

Trial Site Locations

Total: 3 locations

1

Xijing Hospital, Ari Force Medical University

Xi'an, Shannxi, China, 400041

Actively Recruiting

2

First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China, 310000

Actively Recruiting

3

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China, 310000

Actively Recruiting

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Research Team

C

Chenggang Yi, M.D.

S

Songxue Guo, M.D.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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