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

Kidney Transplant Rejection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05600634
• Other study ID #: 2023-0719
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: October 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Chenggang Yi, M.D.
• Phone: +8613567113534
• Email: cwar[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 31, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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;

Related Conditions & MeSH terms

• Kidney Transplant Rejection
• Skin Graft

Intervention

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.

Locations

Country	Name	City	State
China	First Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	Xijing Hospital, Ari Force Medical University	Xi'an	Shannxi

Sponsors (4)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	Sir Run Run Shaw Hospital, Xijing Hospital, Air Force Medical University, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2017 Banff Kidney Transplantation Rejection Rating	A rating evaluation on kidney rejection	Through study completion, an average of 1 year
Primary	2007-edition Banff skin containing allogeneic composite histopathological diagnosis grading	Skin histopathological diagnosis	Through study completion, an average of 1 year
Primary	Renal function testing	Blood Cr and Bun testing	Through study completion, an average of 1 year
Secondary	Renal ultrasound diagnosis	Renal ultrasound diagnosis	Through study completion, an average of 1 year
Secondary	Complications	Complications assessment	Through study completion, an average of 1 year