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

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05600634
• Collaborator: Zhejiang University (Other), Sir Run Run Shaw Hospital (Other), Xijing Hospital, Air Force Medical University (Other)
• Enrollment: 24
• Locations: 3
• Anticipated Duration (Months): 36
• Patients Per Site: 8
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplant Rejection; Skin Graft	Procedure: Skin allotransplantation

Study Design

• Study Type: Observational
• Anticipated Enrollment: 24 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Multi Center Clinical Observation of Sentinel Skin Graft From the Same Donor Source for Detecting Acute Rejection After Renal Transplantation
• Anticipated Study Start Date: Jan 1, 2023
• Anticipated Primary Completion Date: Jun 30, 2025
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. 2017 Banff Kidney Transplantation Rejection Rating [Through study completion, an average of 1 year]

   A rating evaluation on kidney rejection

2. 2007-edition Banff skin containing allogeneic composite histopathological diagnosis grading [Through study completion, an average of 1 year]

   Skin histopathological diagnosis

3. Renal function testing [Through study completion, an average of 1 year]

   Blood Cr and Bun testing

Secondary Outcome Measures

1. Renal ultrasound diagnosis [Through study completion, an average of 1 year]

   Renal ultrasound diagnosis

2. Complications [Through study completion, an average of 1 year]

   Complications assessment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xijing Hospital, Ari Force Medical University	Xi'an	Shannxi	China	400041
2	First Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang	China	310000
3	Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang	China	310000

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
• ClinicalTrials.gov Identifier: NCT05600634
• Other Study ID Numbers: 2022-0479
• First Posted: Oct 31, 2022
• Last Update Posted: Oct 31, 2022
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Oct 31, 2022