Applications of MRI in Kidney Disease

Withdrawn

• Conditions: Chronic Kidney Disease; End-stage Kidney Disease
• Interventions: Other: No intervention but only observational

• Registration Number: NCT02832505
• Lead Sponsor: University of Minnesota

Brief Summary

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.

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 Timeline

• Study First Submitted: 2016-06-15
• Study First Submitted QC: 2016-07-11
• Study First Posted: 2016-07-14
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-25
• Study Start: 2025-10-30
• Primary Completion: 2026-08-30
• Study Completion: 2028-08-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CKD (chronic kidney disease)	No intervention but only observational	Patients with Patients with moderate to severe CKD (eGFR ranging from 26 to 44 ml/min/1.73 mm2). No intervention but only observational.
ESRD (end-stage renal disease)	No intervention but only observational	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.
Non-CKD (Control)	No intervention but only observational	Patients without CKD (eGFR ≥ 60 ml/min/1.73 mm2) (non-CKD controls). No intervention but only observational.

Primary Outcome Measures

Name	Time	Method
MRI measured perfusion for each patient group	Baseline	MRI measurements will be summarized for each patient group by using mean and standard deviation or standard error.

Trial Locations

Locations (1)

University of Minnesota Medical Center; 🇺🇸 Minneapolis, Minnesota, United States