Applications of MRI in Kidney Disease

This study has two major purposes:

1. To test developed multiple anatomic and functional MRI methods;
2. To evaluate the potentials of these MRI methods in the diagnosis, prognosis, and monitoring of the progression of renal dysfunction.

These purposes will be achieved by performing pilot studies with cohorts of patients.

Study Overview

• Status: Withdrawn
• Conditions: Chronic Kidney Disease; End-stage Kidney Disease
• Intervention / Treatment: Other: No intervention but only observational

Detailed Description

This study is observational with no intervention applied for the patients. In this study, multiple anatomic and functional MRI methods will be performed with three cohorts of patients. In addition to anatomic MRI methods, non-contrast enhanced functional MRI methods will also be applied to evaluate tissue perfusion and vascular reactivity in these patients.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population will include three main cohorts of patients: 20 ESRD patients with their transition to dialysis treatment, 20 CKD controls and 20 non-CKD controls. Based on the investigators previous experience, about 20% of recruited subjects may not be able to finish the proposed studies. Therefore, a conservative estimate of the total number of subjects to be recruited is 72.

Description

Inclusion Criteria:

1. English-speaking as primary language
2. Able to complete an approximately 75 to 90 minute cognitive and/or physical tests
3. Capable to consent to studies

Exclusion Criteria:

1. Acute psychiatric illness that would impede cognitive testing
2. Active chemical dependence, such as alcohol, narcotics or other drugs
3. Legally blind or unable to complete cognitive tests due to visual loss or deafness
4. Renal transplant recipient at time of screening or baseline
5. Severe CI unable to complete the Modified Mini-Mental State Examination [3MSE]
6. Chronic and acute pulmonary disease

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-CKD (Control); Patients without CKD (eGFR ≥ 60 ml/min/1.73 mm2) (non-CKD controls). No intervention but only observational.	Other: No intervention but only observational; This study is a cross-sectional and observational MRI study with three cohorts of patients, and no interventions will be applied.
CKD (chronic kidney disease); Patients with Patients with moderate to severe CKD (eGFR ranging from 26 to 44 ml/min/1.73 mm2). No intervention but only observational.	Other: No intervention but only observational; This study is a cross-sectional and observational MRI study with three cohorts of patients, and no interventions will be applied.
ESRD (end-stage renal disease); Patients with advanced CKD (eGFR < 15 ml/min/1.73 mm2), preparing for or undergoing the standard thrice-weekly HD or standard PD treatment (end-stage renal disease (ESRD) patients). No intervention but only observational.	Other: No intervention but only observational; This study is a cross-sectional and observational MRI study with three cohorts of patients, and no interventions will be applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI measured perfusion for each patient group	MRI measurements will be summarized for each patient group by using mean and standard deviation or standard error.	Baseline

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Xiufeng Li, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Estimated): October 30, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2028

Study Registration Dates

• First Submitted: June 15, 2016
• First Submitted That Met QC Criteria: July 11, 2016
• First Posted (Estimated): July 14, 2016

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 20, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Kidney Diseases; Kidney Failure, Chronic; Renal Insufficiency, Chronic
• Other Study ID Numbers: 1603M85321

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO