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

NCT ID: NCT05600634

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney Transplant Rejection Skin Graft

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Kidney and skin transplataiton

Skin allotransplantation

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang University

OTHER

Sponsor Role collaborator

Sir Run Run Shaw Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Air Force Medicial University

OTHER

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Xijing Hospital, Ari Force Medical University

Xi'an, Shannxi, China

Site Status RECRUITING

First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

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

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chenggang Yi, M.D.

Role: CONTACT

+8613567113534

Songxue Guo, M.D.

Role: CONTACT

+8618506857388

Facility Contacts

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Geng Zhang, M.D.

Role: primary

Jinghong Xu, M.D.

Role: primary

Weiqiang Tan, M.D.

Role: primary

+8613666658609

Other Identifiers

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2023-0719

Identifier Type: -

Identifier Source: org_study_id