Kidney DiseasesARCFNCT03964948
Kidney Fibrosis and MRI
A study testing Kidney MRI in people with Kidney Diseases, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Diseases
- What is being tested?
- Kidney MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2018to 18 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Development of Novel MRI Methods for Detecting and Measuring Renal Injury/Fibrosis
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.
- Conditions
- Kidney Diseases
- Being tested
- Kidney MRI
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kidney MRIDiagnostic test
An MRI examination will be completed per research MRI protocol.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: Kidney MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of noninvasive MRI methods to measure kidney disease using MR elastography.
Measured: 3 years
Development of noninvasive MRI methods to measure kidney disease using quantitative T1 mapping.
Measured: 3 years
Development of noninvasive MRI methods to measure kidney disease using T1rho mapping.
Measured: 3 years
Development of noninvasive MRI methods to measure kidney disease using T2 mapping.
Measured: 3 years
Development of noninvasive MRI methods to measure kidney disease using magnetization transfer imaging.
Measured: 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start6 Aug 2018
- Primary completion18 Jun 2021
- Study completion18 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03964948
- Sponsor's protocol ID
- 2018-4428
- Acronym
- ARCF
- Status last verified
- Sep 2021
- First submitted
- 20 May 2019
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Novel MRI Methods for Detecting and Measuring Renal Injury/Fibrosis
- ClinicalTrials.gov ID
- NCT03964948
- Acronym / sponsor ID
- ARCF / 2018-4428
- Conditions
- Kidney Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 18 Jun 2021 (actual)
- Study completion
- 18 Jun 2021 (actual)
- First posted
- 28 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Other | Diagnostic Test: Kidney MRI20 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. |
| Kidney Transplant | Other | Diagnostic Test: Kidney MRI20 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. |
| Stage 2-5 CKD | Other | Diagnostic Test: Kidney MRI20 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. |
| Lupus nephritis | Other | Diagnostic Test: Kidney MRI20 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. |
Who may qualify
- Ages
- 10 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- ≥ 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kidney MRIAn MRI examination will be completed per research MRI protocol. | Diagnostic test | Healthy Volunteers, Kidney Transplant, Lupus nephritis, Stage 2-5 CKD |
Primary outcome
Development of noninvasive MRI methods to measure kidney disease using MR elastography.
Time frame: 3 years
Development of noninvasive MRI methods to measure kidney disease using quantitative T1 mapping.
Time frame: 3 years
Development of noninvasive MRI methods to measure kidney disease using T1rho mapping.
Time frame: 3 years
Development of noninvasive MRI methods to measure kidney disease using T2 mapping.
Time frame: 3 years
Development of noninvasive MRI methods to measure kidney disease using magnetization transfer imaging.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kidney MRI in people with Kidney Diseases, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of noninvasive MRI methods to measure kidney disease using MR elastography. (time frame: 3 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021.