Kidney Fibrosis and MRI

NCT ID: NCT03964948

Last Updated: 2021-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-06

Study Completion Date

2021-06-18

Brief Summary

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The investigators plan a prospective cross-sectional study of pediatric and adult healthy volunteers and patients with chronic kidney disease that will correlate a variety of quantitative MRI biomarkers with severity of renal insufficiency and available histopathology. Over 3 years, the investigators will recruit approximately 20 healthy volunteers, 20 patients with chronic kidney disease (CKD) Stage 2-5, and 20 patients with renal transplant kidneys. The investigators also plan to assess the effect of inflammation on the quantitative MRI biomarkers by recruiting approximately 20 additional patients with active lupus nephritis.

Detailed Description

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Conditions

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Kidney Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Healthy Volunteers

20 healthy volunteers will be recruited and will receive a kidney MRI and the same blood and urine labs that are collected for the other arms. Results will be compared to the disease groups.

Group Type OTHER

Kidney MRI

Intervention Type DIAGNOSTIC_TEST

An MRI examination will be completed per research MRI protocol.

Kidney Transplant

20 subjects that have received a kidney transplant that have had a biopsy performed within the past 12 months will be enrolled. They will receive a kidney MRI and will have blood and urine collected.

Group Type OTHER

Kidney MRI

Intervention Type DIAGNOSTIC_TEST

An MRI examination will be completed per research MRI protocol.

Stage 2-5 CKD

20 subjects that have been diagnosed with stage 2-5 CKD and have had a biopsy performed within the past 12 months will be enrolled. They will receive a kidney MRI and will have blood and urine collected.

Group Type OTHER

Kidney MRI

Intervention Type DIAGNOSTIC_TEST

An MRI examination will be completed per research MRI protocol.

Lupus nephritis

20 subjects that have that have active lupus nephritis and have had a biopsy performed within the past 12 months will be enrolled. They will receive a kidney MRI and will have blood and urine collected.

Subjects that are post-lupus treatment will receive an additional MRI at the time of the next biopsy.

Group Type OTHER

Kidney MRI

Intervention Type DIAGNOSTIC_TEST

An MRI examination will be completed per research MRI protocol.

Interventions

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Kidney MRI

An MRI examination will be completed per research MRI protocol.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

Subjects who meet all of the following criteria will be eligible for the study:

1. ≥ 10 and ≤ 25 years of age and;
2. Kidney transplant patients, who have had a recent kidney biopsy (within 1 year) that shows interstitial fibrosis OR
3. Patients with CKD Stage 2-5 who have previously had a biopsy (within 1 year) OR
4. Lupus patients with active nephritis who will undergo biopsy evaluation before and after induction therapy OR
5. Healthy Controls

Exclusion Criteria

Subjects who meet any of the following criteria will be excluded from the study:

1. Known contraindication to MR imaging (e.g., implanted non-MRI compatible device)
2. Known or suspected pregnancy. Female subjects of child bearing potential will undergo a urine pregnancy test prior to imaging.
3. Inability to undergo MRI without sedation/anesthesia.
4. Non-English Speaking
Minimum Eligible Age

10 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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2018-4428

Identifier Type: -

Identifier Source: org_study_id

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