VisR Ultrasound for Noninvasively Monitoring Renal Allograft Health

NCT03079882 | Completed

• 2 other identifiers: 15-29341R01DK107740
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

Ten percent of American adults, more than 20 million people, have chronic kidney disease, which in the advanced state of end stage renal disease is most desirably and cost-effectively treated by kidney transplantation. However, 20-30% of transplanted kidneys fail in living recipients by 10 years, owing largely to insufficient monitoring methods. The goal of the proposed research is to improve noninvasive kidney transplant monitoring using a new ultrasound-based imaging method called Viscoelastic Response (VisR) ultrasound.

Conditions

Renal Transplant Failure

Keywords

Ultrasound; Viscoelasticity; Viscoelastic Response (VisR) Ultrasound

Outcome Measures

Primary Outcomes (1)

• VisR AUC value

  AUC for VisR to detect positive biopsy finding (indiscriminate of type)

  at time of clinically indicated biopsy

Secondary Outcomes (11)

• AUC for the ability of change in serum creatinine level to detect positive biopsy finding

  at time of clinically indicated biopsy

• AUC for the ability of change in VisR Tau value to detect positive biopsy finding

  at time of clinically indicated biopsy

• AUC for the ability of change in VisR Relative Elasticity value to detect positive biopsy finding

  at time of clinically indicated biopsy

• AUC for the ability of change in VisR Relative Viscosity value to detect positive biopsy finding

  at time of clinically indicated biopsy

• Change in serum creatinine level

  1-2 weeks, 4 weeks, 2 months, 3 months, 6 months, 9 months, 12 months, and then every 4 months after transplantation until time of clinically indicated biopsy or 3 years after transplantation, which ever comes first

Study Arms (2)

Living Donor Recipients

Recipients of renal transplants with the transplanted organ originating from living donors

Deceased Donor Recipients

Recipients of renal transplants with the transplanted organ originating from deceased donors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This unblinded, open-label, exploratory study will be conducted in 100 consecutively evaluable patients (50 with renal allografts from living donors and 50 with allografts from deceased donors). Patients will be recruited from those already undergoing renal transplant surgery for end stage renal disease based on the standard of care at UNC Hospitals. Potential study participants will be patients 18 years of age or older who have been selected by their treating physician to be in need of renal transplant surgery for end stage renal disease at University of North Carolina Hospitals' Nephrology Transplant clinic. Participants will be enrolled in two groups, as living or deceased donor recipients. There will be no intervention beyond VisR ultrasound imaging.

You may qualify if:

• At least 18 years of age
• Selected by treating physician to be in need of renal transplant surgery
• Ability to provide informed consent
• Ability to communicate with pertinent staff
• Ability to understand and comply with study requirements

You may not qualify if:

• Inability to provide valid consent
• Inability to communicate with pertinent staff
• Inability to remain motionless for at least 20 minutes
• Renal transplant deeper than 4 cm

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Study Officials

• Caterina M Gallippi, Ph.D.

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2017
• First Posted: March 15, 2017
• Study Start: June 16, 2016
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: June 24, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)