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Kidney Volume in Live Donors Kidney Transplant Donors and Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06216795
Recruitment Status : Recruiting
First Posted : January 22, 2024
Last Update Posted : January 24, 2024
Sponsor:
Collaborator:
Severance Hospital
Information provided by (Responsible Party):
Seoul National University Hospital

Study Description
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Brief Summary:
The investigators aim to investigate the association between renal volume measured through pre-donation CT auto-segmentation and postoperative renal function of both donors and recipients. After establishing the statistical significance of the association, the investigators intend to create and validate predictive models for renal function at surgery, 1 year, and 3 years postoperatively, incorporating various factors known to contribute to renal function deterioration.

Condition or disease
Kidney Transplant; Complications

Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Measurement of Kidney Volume Using Computed Tomography in Kidney Transplant Donors and Recipients
Actual Study Start Date : May 24, 2022
Estimated Primary Completion Date : April 23, 2024
Estimated Study Completion Date : December 31, 2024

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Groups and Cohorts
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Group/Cohort
kidney transplant group


Outcome Measures
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Primary Outcome Measures :
  1. Prediction models for the residual renal function of donors and the graft kidney function of recipient after live donor kidney transplantation [ Time Frame: 1 and 3 years after transplantation ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
live kidney donors and paired their recipients.
Criteria

Inclusion Criteria:

  • live donor kidney transplant

Exclusion Criteria:

  • donors without preoperative enhanced CT image
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06216795


Contacts
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Contact: Sangil Min, MD, PhD 01071739341 surgeonmsi@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Sang-Il Min, MD    82-2-2072-2330    surgeonmsi@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
Severance Hospital
More Information
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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT06216795    
Other Study ID Numbers: SNUH-Kidney Volumetry_KT_v1.3
First Posted: January 22, 2024    Key Record Dates
Last Update Posted: January 24, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No