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Recruiting NCT05600634

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

— Observational Kidney Transplant Rejection Skin Graft

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Skin allotransplantation.
Who it may be relevant to
Registry conditions: Kidney Transplant Rejection, Skin Graft. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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.

Primary outcome measures

  • 2017 Banff Kidney Transplantation Rejection Rating [Time frame: Through study completion, an average of 1 year]
  • 2007-edition Banff skin containing allogeneic composite histopathological diagnosis grading [Time frame: Through study completion, an average of 1 year]
  • Renal function testing [Time frame: Through study completion, an average of 1 year]
Secondary outcome measures (2)
  • Renal ultrasound diagnosis [Time frame: Through study completion, an average of 1 year]
  • Complications [Time frame: Through study completion, an average of 1 year]

Eligibility criteria

Inclusion criteria

  • Patients with end-stage renal disease undergoing renal transplantation;
  • 18-60 years old;
  • 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);
  • The participants had good compliance, volunteered to participate in the test and signed the informed consent form.

Exclusion criteria

  • Untreated or disseminated malignant tumor;
  • Active period of infectious diseases;
  • Serious cardiovascular disease occurred recently;
  • Combined with other important organ failure;
  • History of mental illness or cognitive impairment;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

China · 3 centers
  • Xijing Hospital, Ari Force Medical University — Xi'an
  • First Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou
  • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University — Hangzhou

Identifiers

NCT: NCT05600634 · 2023-0719

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗