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NCT Number: NCT05600634

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

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.

Recruiting

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Xijing Hospital, Ari Force Medical University, Xi'an, Shannxi, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Skin allotransplantation

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.

Primary outcomes

  1. 2017 Banff Kidney Transplantation Rejection Rating

    Time frame: 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

    Time frame: Through study completion, an average of 1 year

    Skin histopathological diagnosis

  3. Renal function testing

    Time frame: Through study completion, an average of 1 year

    Blood Cr and Bun testing

Secondary outcomes

  1. Renal ultrasound diagnosis

    Time frame: Through study completion, an average of 1 year

    Renal ultrasound diagnosis

  2. Complications

    Time frame: Through study completion, an average of 1 year

    Complications assessment

Study contacts

Contact information is provided by the study sponsor or research team.

Chenggang Yi, M.D.

CONTACT

[email protected]

+8613567113534

Songxue Guo, M.D.

CONTACT

[email protected]

+8618506857388

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

  • Sir Run Run Shaw Hospital
  • The First Affiliated Hospital of Air Force Medicial University
  • Zhejiang University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 31, 2022
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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