Using skin grafts to detect kidney transplant rejection

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

This study tests whether skin grafts from kidney donors can help doctors spot early signs of kidney transplant rejection in patients.

Quick facts

• Study type: Observational
• Enrollment: 24 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Locations: 3 sites (Xi'an, Shannxi and 2 other locations)
• Trial ID: NCT05600634 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the effectiveness of sentinel skin grafts from the same donor in diagnosing acute rejection of renal transplants. By monitoring patients who have undergone kidney transplantation, the study seeks to provide insights into the timing and methods for early immunization interventions. Participants will be closely followed post-surgery to assess the accuracy of skin grafts in indicating renal allograft rejection. The study involves multiple centers to gather diverse data and improve the reliability of findings.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-60 with end-stage renal disease who are undergoing renal transplantation.

Not a fit: Patients with untreated malignancies, active infections, or significant cardiovascular issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to earlier detection of kidney transplant rejection, improving patient outcomes.

How similar studies have performed: While the use of skin grafts in this context is innovative, similar approaches in transplant rejection monitoring have shown promise in other studies.

Eligibility criteria

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;

Where this trial is running

Xi'an, Shannxi and 2 other locations

• Xijing Hospital, Ari Force Medical University — Xi'an, Shannxi, China (Recruiting)
• First Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
• Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Chenggang Yi, M.D.

Conditions Kidney Transplant Rejection; Skin Graft