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Kidney Volume in Live Donors Kidney Transplant Donors and Recipients

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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

Tracking Information
First Submitted Date January 11, 2024
First Posted Date January 22, 2024
Last Update Posted Date January 24, 2024
Actual Study Start Date May 24, 2022
Estimated Primary Completion Date April 23, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 11, 2024)		 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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Kidney Volume in Live Donors Kidney Transplant Donors and Recipients
Official Title Measurement of Kidney Volume Using Computed Tomography in Kidney Transplant Donors and Recipients
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population live kidney donors and paired their recipients.
Condition Kidney Transplant; Complications
Intervention Not Provided
Study Groups/Cohorts kidney transplant group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 11, 2024)		 1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2024
Estimated Primary Completion Date April 23, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • live donor kidney transplant

Exclusion Criteria:

  • donors without preoperative enhanced CT image
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Sangil Min, MD, PhD 01071739341 surgeonmsi@gmail.com
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT06216795
Other Study ID Numbers SNUH-Kidney Volumetry_KT_v1.3
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party Seoul National University Hospital
Original Responsible Party Same as current
Current Study Sponsor Seoul National University Hospital
Original Study Sponsor Same as current
Collaborators Severance Hospital
Investigators Not Provided
PRS Account Seoul National University Hospital
Verification Date January 2024