Kidney Transplant RejectionNCT05600634
Multi Center Observation of Sentinel Skin Graft for Detecting Acute Rejection After Renal Transplantation
An observational study of Kidney Transplant Rejection and Skin Graft, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Kidney Transplant Rejection, Skin Graft
- What is being tested?
- Skin allotransplantation
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jan 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: This study is an exploratory study. In the early stage, there is no relevant study on the accuracy of sentinel skin flap monitoring renal rejection, and there is a lack of corresponding sensitivity and specificity indicators. Considering that the incidence of acute rejection in the first year after transplantation is 15-30%, it is estimated that 20 cases will be included. Because the experimental data may be lost, or the participants may withdraw from the trial or lose the interview, the sample size will be increased by 20%, and finally 24 cases will be included in the trial.
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
Jinghong Xu, M.D.
- Recruiting
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
Weiqiang Tan, M.D., +8613666658609, tanweixxxx@163.com
- Recruiting
Xijing Hospital, Ari Force Medical University
Xi'an, Shannxi, 400041
Geng Zhang, M.D.
About this study
Official title: Multi Center Clinical Observation of Sentinel Skin Graft From the Same Donor Source 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.
- Conditions
- Kidney Transplant Rejection, Skin Graft
- Being tested
- Skin allotransplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin allotransplantationProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Kidney and skin transplataiton | Not described Receives: Procedure: Skin allotransplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
2017 Banff Kidney Transplantation Rejection Rating
A rating evaluation on kidney rejection
Measured: Through study completion, an average of 1 year
2007-edition Banff skin containing allogeneic composite histopathological diagnosis grading
Skin histopathological diagnosis
Measured: Through study completion, an average of 1 year
Renal function testing
Blood Cr and Bun testing
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Renal ultrasound diagnosis
Renal ultrasound diagnosis
Measured: Through study completion, an average of 1 year
Complications
Complications assessment
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start1 Jan 2024 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant RejectionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang University, Sir Run Run Shaw Hospital, The First Affiliated Hospital of Air Force Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05600634
- Sponsor's protocol ID
- 2023-0719
- Status last verified
- Oct 2023
- First submitted
- 27 Oct 2022
- Last updated
- 28 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi Center Clinical Observation of Sentinel Skin Graft From the Same Donor Source for Detecting Acute Rejection After Renal Transplantation
- ClinicalTrials.gov ID
- NCT05600634
- Acronym / sponsor ID
- 2023-0719
- Conditions
- Kidney Transplant Rejection, Skin Graft
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Zhejiang University, Sir Run Run Shaw Hospital, The First Affiliated Hospital of Air Force Medical University
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kidney and skin transplataiton | – | Procedure: Skin allotransplantation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study is an exploratory study. In the early stage, there is no relevant study on the accuracy of sentinel skin flap monitoring renal rejection, and there is a lack of corresponding sensitivity and specificity indicators. Considering that the incidence of acute rejection in the first year after transplantation is 15-30%, it is estimated that 20 cases will be included. Because the experimental data may be lost, or the participants may withdraw from the trial or lose the interview, the sample size will be increased by 20%, and finally 24 cases will be included in the trial.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin allotransplantationSentinel skin grafts from the same donor source will be carried on in the meantime of kidney transplantation for assisting to detect acute renal rejection. | Procedure or surgery | Kidney and skin transplataiton |
Primary outcome
2017 Banff Kidney Transplantation Rejection Rating
Time frame: Through study completion, an average of 1 year
A rating evaluation on kidney rejection
2007-edition Banff skin containing allogeneic composite histopathological diagnosis grading
Time frame: Through study completion, an average of 1 year
Skin histopathological diagnosis
Renal function testing
Time frame: Through study completion, an average of 1 year
Blood Cr and Bun testing
2 secondary outcomes
Renal ultrasound diagnosis
Time frame: Through study completion, an average of 1 year
Complications
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Kidney Transplant Rejection
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Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
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(TNX-1500) in Kidney Transplant Recipients
Kidney Transplant, Kidney Transplant Failure and Rejection
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A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
Microvascular Inflammation
Not yet recruitingObservational study
Assessment of Perceived Stress in an Observational Study Evaluating a Biopsy-sparing Surveillance Strategy in Kidney Transplant Recipients With Blood and Urinary Biomarkers Predictive of the Absence of Rejection
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant Rejection and Skin Graft, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chenggang Yi, M.D. (+8613567113534, cwar@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2017 Banff Kidney Transplantation Rejection Rating (time frame: Through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.