- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03964948
Kidney Fibrosis and MRI (ARCF)
Development of Novel MRI Methods for Detecting and Measuring Renal Injury/Fibrosis
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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.
|
An MRI examination will be completed per research MRI protocol.
|
Other: 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.
|
An MRI examination will be completed per research MRI protocol.
|
Other: 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.
|
An MRI examination will be completed per research MRI protocol.
|
Other: 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. |
An MRI examination will be completed per research MRI protocol.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Development of noninvasive MRI methods to measure kidney disease using MR elastography.
Time Frame: 3 years
|
3 years
|
|
Development of noninvasive MRI methods to measure kidney disease using quantitative T1 mapping.
Time Frame: 3 years
|
3 years
|
|
Development of noninvasive MRI methods to measure kidney disease using T1rho mapping.
Time Frame: 3 years
|
3 years
|
|
Development of noninvasive MRI methods to measure kidney disease using T2 mapping.
Time Frame: 3 years
|
3 years
|
|
Development of noninvasive MRI methods to measure kidney disease using magnetization transfer imaging.
Time Frame: 3 years
|
3 years
|
|
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.
|
3 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-4428
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Kidney Diseases
-
3-C Institute for Social DevelopmentUniversity of North Carolina, Chapel HillCompletedChronic Kidney Diseases | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Pediatric Kidney Disease | Chronic Kidney Disease stage3 | Chronic Kidney Disease Stage V | Chronic Kidney Disease, Stage IV (Severe) | Chronic Kidney Disease Stage 2 | Chronic Kidney Disease, Stage IUnited States
-
University of North Carolina, Chapel HillLantheus Medical ImagingCompletedChronic Kidney Diseases | Cystic Kidney DiseaseUnited States
-
SanofiTerminatedCongenital Cystic Kidney DiseaseGermany, Spain, United States, Australia, Belgium, Japan, Korea, Republic of, Netherlands
-
University of UtahNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)RecruitingHemodialysis | Kidney Disease, Chronic | Kidney Failure | Dialysis | Diabetic | End-stage Kidney Disease | Kidney Dysfunction | Non-diabeticUnited States
-
Pang PengGuangdong Provincial Hospital of Traditional Chinese MedicineUnknownEnd-Stage Kidney Disease | Chronic Kidney FailureChina
-
Universiti Putra MalaysiaRecruitingChronic Kidney Diseases | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Chronic Kidney Disease stage3 | Chronic Kidney Disease Requiring Chronic DialysisMalaysia
-
George Washington UniversityCareDx; VirginiaBio Analytics, LLCTerminatedKidney Diseases | Kidney Failure, Chronic | Kidney Transplant Infection | Kidney Transplant Rejection | Kidney Injury | Kidney Disease, Chronic | Kidney Failure | Kidney Failure, Acute | Kidney Transplant; Complications | Kidney IschemiaUnited States
-
RenJi HospitalUnknownKidney Diseases,CysticChina
-
Renibus Therapeutics, Inc.CompletedKidney Failure, AcuteUnited States
-
Emory UniversityNorthwestern University; Columbia University; Satellite Healthcare; Norman S. Coplon...CompletedKidney Failure, Chronic | Kidney Transplantation | End-Stage Kidney DiseaseUnited States
Clinical Trials on Kidney MRI
-
Hospices Civils de LyonNot yet recruitingRenal Insufficiency, Chronic
-
Hamid Al-Essa Organ Transplant CenterCompletedCOVID-19 Positive Patients With Acute Kidney InjuryKuwait
-
University Medical Center GroningenRadboud University Medical Center; Maastricht University Medical Center; UMC... and other collaboratorsRecruitingKidney Transplantation | Immunosuppression | Antibody-mediated RejectionNetherlands
-
Charles University, Czech RepublicRecruiting
-
University of MichiganNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); The...RecruitingGlomerulosclerosis, Focal Segmental | Membranous Nephropathy | Minimal Change Disease (MCD)United States, Canada
-
Weill Medical College of Cornell UniversityQatar National Research FundSuspendedKidney TransplantationUnited States
-
Radboud University Medical CenterCompletedKidney Transplant FailureNetherlands
-
Asan Medical CenterUlsan University Hospital; Korea University Anam Hospital; Inje University; Hallym...UnknownKidney Transplant Failure | Renal FibrosisKorea, Republic of
-
Guy's and St Thomas' NHS Foundation TrustUnknownTransplant;Failure,Kidney
-
CHU de ReimsUnknownHenoch Schönlein NephritisFrance