NCT03964948

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 6, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 28, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2021

Completed
Last Updated

September 9, 2021

Status Verified

September 1, 2021

Enrollment Period

2.9 years

First QC Date

May 20, 2019

Last Update Submit

September 8, 2021

Conditions

Kidney Diseases

Outcome Measures

Primary Outcomes (6)

  • Development of noninvasive MRI methods to measure kidney disease using MR elastography.

    3 years

  • Development of noninvasive MRI methods to measure kidney disease using quantitative T1 mapping.

    3 years

  • Development of noninvasive MRI methods to measure kidney disease using T1rho mapping.

    3 years

  • Development of noninvasive MRI methods to measure kidney disease using T2 mapping.

    3 years

  • Development of noninvasive MRI methods to measure kidney disease using magnetization transfer imaging.

    3 years

  • Development of noninvasive MRI methods to measure kidney disease using diffusion-weighted imaging.

    Intra-voxel incoherent motion and diffusion tensor imagining will be measured.

    3 years

Study Arms (4)

Healthy Volunteers

OTHER

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.

Diagnostic Test: Kidney MRI

Kidney Transplant

OTHER

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.

Diagnostic Test: Kidney MRI

Stage 2-5 CKD

OTHER

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.

Diagnostic Test: Kidney MRI

Lupus nephritis

OTHER

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.

Diagnostic Test: Kidney MRI

Interventions

Kidney MRIDIAGNOSTIC_TEST

An MRI examination will be completed per research MRI protocol.

Healthy VolunteersKidney TransplantLupus nephritisStage 2-5 CKD

Eligibility Criteria

Age10 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Subjects who meet all of the following criteria will be eligible for the study:
  • ≥ 10 and ≤ 25 years of age and;
  • Kidney transplant patients, who have had a recent kidney biopsy (within 1 year) that shows interstitial fibrosis OR
  • Patients with CKD Stage 2-5 who have previously had a biopsy (within 1 year) OR
  • Lupus patients with active nephritis who will undergo biopsy evaluation before and after induction therapy OR
  • Healthy Controls

You may not qualify if:

  • Subjects who meet any of the following criteria will be excluded from the study:
  • Known contraindication to MR imaging (e.g., implanted non-MRI compatible device)
  • Known or suspected pregnancy. Female subjects of child bearing potential will undergo a urine pregnancy test prior to imaging.
  • Inability to undergo MRI without sedation/anesthesia.
  • Non-English Speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2019

First Posted

May 28, 2019

Study Start

August 6, 2018

Primary Completion

June 18, 2021

Study Completion

June 18, 2021

Last Updated

September 9, 2021

Record last verified: 2021-09

Locations

US(1)