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Kidney Fibrosis and MRI (ARCF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03964948
Recruitment Status : Recruiting
First Posted : May 28, 2019
Last Update Posted : May 28, 2019
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

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.

Condition or disease Intervention/treatment Phase
Kidney Diseases Diagnostic Test: Kidney MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Development of Novel MRI Methods for Detecting and Measuring Renal Injury/Fibrosis
Actual Study Start Date : August 6, 2018
Estimated Primary Completion Date : August 6, 2021
Estimated Study Completion Date : August 6, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
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.
Diagnostic Test: Kidney MRI
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.
Diagnostic Test: Kidney MRI
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.
Diagnostic Test: Kidney MRI
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.

Diagnostic Test: Kidney MRI
An MRI examination will be completed per research MRI protocol.




Primary Outcome Measures :
  1. Development of noninvasive MRI methods to measure kidney disease using MR elastography. [ Time Frame: 3 years ]
  2. Development of noninvasive MRI methods to measure kidney disease using quantitative T1 mapping. [ Time Frame: 3 years ]
  3. Development of noninvasive MRI methods to measure kidney disease using T1rho mapping. [ Time Frame: 3 years ]
  4. Development of noninvasive MRI methods to measure kidney disease using T2 mapping. [ Time Frame: 3 years ]
  5. Development of noninvasive MRI methods to measure kidney disease using magnetization transfer imaging. [ Time Frame: 3 years ]
  6. Development of noninvasive MRI methods to measure kidney disease using diffusion-weighted imaging. [ Time Frame: 3 years ]
    Intra-voxel incoherent motion and diffusion tensor imagining will be measured.



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Ages Eligible for Study:   10 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03964948


Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Katy Fischesser    513-803-5191    hircregulatory@cchmc.org   
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT03964948    
Other Study ID Numbers: 2018-4428
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: May 28, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Urologic Diseases