Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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.
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
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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