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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05600634

Enrollment

Registered

2022-10-31

Start date

2024-01-01

Completion date

2026-12-31

Last updated

2023-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplant Rejection, Skin Graft

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.

Interventions

PROCEDURESkin 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.

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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;

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Renal ultrasound diagnosis	Through study completion, an average of 1 year	Renal ultrasound diagnosis
Complications	Through study completion, an average of 1 year	Complications assessment

Countries

China

Contacts

Primary ContactChenggang Yi, M.D.

cwar@163.com+8613567113534

Backup ContactSongxue Guo, M.D.

guosongxue@zju.edu.cn+8618506857388

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026