Applications of MRI in Kidney Disease

NCT02832505 | Withdrawn

• 1 other identifier: 1603M85321
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study has two major purposes:

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

Conditions

Chronic Kidney Disease; End-stage Kidney Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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

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

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

Interventions

No intervention but only observational OTHER

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); ESRD (end-stage renal disease); Non-CKD (Control)

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiufeng Li

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 15, 2016
• First Posted: July 14, 2016
• Study Start: October 30, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2028
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)