Autosomal Recessive Polycystic Kidney DiseaseIMAGE-ARPKDNCT07201025
Imaging Assessments of ARPKD Kidney Disease Progression
An observational study of Autosomal Recessive Polycystic Kidney Disease, run by The Cleveland Clinic at 2 sites in United States.
Trial summary
Autosomal Recessive Polycystic Kidney Disease (ARPKD) is a potentially lethal genetic disorder for which there are currently no disease specific treatments. Clinical trials have been limited by the absence of robust measures of disease progression. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autosomal Recessive Polycystic Kidney Disease
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Dec 2024to 28 Feb 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Inclusion criteria: ALL SUBJECTS * Ages >6 years old * Able to lay still for 30 minutes in an MRI scanner ARPKD Patients * Clinical and/or genetic diagnosis of ARPKD * eGFR >30ml/min/1.732 performed within the last year Healthy Controls * Otherwise healthy with no known structural or functional kidney disease * Normal documented blood pressure within the last year Exclusion criteria: ALL SUBJECTS * Contraindications to MRI (e.g. metal implants) * Parental/patient refusal to sign an informed consent/ assent form ARPKD Patients * Prior kidney or other solid organ transplant * eGFR <30ml/min/1.732 and/or anticipated dialysis or kidney transplant within the next 3 years Healthy Controls * Systemic diseases known to place patient at risk for kidney disease (e.g. diabetes mellitus) * Obesity (BMI >95th percentile for age for <18 years old, or BMI>30 for adults) * History of prematurity (<32 weeks)
Who may be able to join
- ALL SUBJECTS
- Ages >6 years old
- Able to lay still for 30 minutes in an MRI scanner ARPKD Patients
- Clinical and/or genetic diagnosis of ARPKD
- eGFR (creatinine based) >30ml/min/1.732 performed within the last year Healthy Controls
- Otherwise healthy with no known structural or functional kidney disease
- No history of hypertension or documented high blood pressure within the last year
Who cannot join
- ALL SUBJECTS
- Contraindications to MRI (e.g. metal implants)
- Parental/patient refusal to sign an informed consent/ assent form ARPKD Patients
- Prior kidney or other solid organ transplant
- eGFR <30ml/min/1.732 Healthy Controls
- Systemic diseases known to place patient at risk for kidney disease (e.g. diabetes mellitus)
- Obesity (BMI >95th percentile for age for <18 years old, or BMI>30 for adults)
- History of prematurity (<32 weeks gestational age)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Research Coordinator, 216-386-9360, pedsresearch@ccf.org
Katherine M Dell, MD
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Erum Hartung, MD, MTR, 215-590-2449, ARPKD_studies@chop.edu
Kathryn Howarth, 267-425-5541
About this study
Autosomal Recessive Polycystic Kidney Disease (ARPKD) is a potentially lethal genetic disorder for which there are currently no disease specific treatments. Clinical trials have been limited by the absence of robust measures of disease progression. The overall goal of this 5 year NIH-funded prospective, observational multicenter study conducted at CC (primary site) and Children's Hospital of Philadelphia (CHOP) (collaborating site) is establish a set of rapid, quantitative, and reproducible novel kidney MRI measures applicable to standard clinical MRI scanners, which could serve as potential biomarkers to measure response to therapy in patients across the disease spectrum and all ages.
The investigators will recruit a total of 45 ARPKD patients and 15 healthy controls at the the two sites . All subjects will be > or = 6yrs old with no contraindications to undergoing MRI (non contrast). ARPKD subjects will be recruited into one of 3 cohorts based on their estimated glomerular filtration rate (eGFR): early CKD (eGFR> or =90ml/min/1.73m2), mild CKD (60-89ml/min/1.73m2) and moderate CKD (30-59ml/min/1.73m2). For ARPKD subjects, participation will last 3 years and consist of a baseline and 3 subsequent annual visits. Healthy controls will only have 1 study visit. Study visits for all participants will include collection of clinical and demographic data, clinical blood and urine tests (E.g. serum creatinine) and MRI imaging. ARPKD (but not healthy subjects) will also undergo a measured GFR test (iohexol clearance) to accurately assess their kidney function.
Read the detailed description
Autosomal Recessive Polycystic Kidney Disease (ARPKD) is a potentially lethal genetic disorder that affects approximately 1/20,000 children and shares common cellular pathophysiology with other cystic kidney diseases, including Autosomal Dominant PKD (ADPKD). The genetics, pathology and clinical features of ARPKD, however, are distinct from ADPKD. In ARPKD, diffuse fusiform dilatations of the collecting tubules ("microcysts") predominate rather than the macrocysts seen in ADPKD. ARPKD kidneys may be very large at presentation, but, unlike ADPKD, actually stabilize in size as normal parenchyma is replaced by cysts and progressive fibrosis develops. ARPKD morbidity and mortality is significant: 30% of children die as neonates and 40-50% of survivors progress to end-stage kidney disease (ESKD) by age 18. Importantly, there are currently no disease-specific, clinically-available therapies for ARPKD and treatment is limited to chronic kidney disease (CKD) management. Several novel therapies have shown promise in ARPKD animal models. Unfortunately, there are currently no reliable clinical measures of ARPKD progression that show changes over a several year period of a clinical trial except in the most severely affected young children, creating a roadblock for implementing clinical trials for ARPKD therapies, especially in patients with less advanced disease.
Conventional endpoints for CKD progression, e.g., 50% decline in estimated glomerular filtration rate (eGFR) or progression to ESKD have substantial limitations in assessing ARPKD progression. Studies from 2 prospective observational cohorts found that the rates of GFR decline in ARPKD patients was relatively slow but also highly variable. Magnetic Resonance Imaging (MRI) measures of total kidney volume (TKV), which have been used successfully in ADPKD trials, are generally not applicable to ARPKD, since TKV does not increase with progressive disease except in severely affected young patients. Therefore, there is a critical need for new, sensitive biomarkers to enable effective clinical trials of therapies for ARPKD. Quantitative MRI techniques, including novel Magnetic Resonance Fingerprinting (MRF), Arterial Spin Labelling (ASL) and Magnetic Resonance Elastography (MRE), have the potential to provide measurable assessments of kidney structure and function. The overall objective of this multi-site study is to establish a set of rapid, quantitative, and reproducible kidney MRI methods applicable to standard clinical MRI scanners, which could serve as potential biomarkers to risk stratify ARPKD patients for clinical trial enrollment and measure response to therapy across the kidney disease spectrum and all ages.
The Aims of this study are (1) to determine the capability of multimodal MRI biomarkers to accurately and repeatably detect and stage ARPKD kidney disease across the full spectrum of disease from early-stage CKD characterized by diffuse kidney cysts (MRF) and reduced kidney perfusion (ASL) to later-stage CKD characterized by progressive kidney fibrosis (MR elastography, MRE); (2) to determine the sensitivity of these MRI biomarkers to detect changes in ARPKD kidney disease progression over time in comparison to gold-standard GFR assessments; and (3) to determine the feasibility of a new free-breathing MRF methodology that would allow infants and young children to be scanned without sedation. For these studies, the investigators will recruit ARPKD patients ≥6 years of age with early, mild, and moderate CKD from across the US for 4 annual multimodal MRI scans and GFR measurements at two collaborating sites (CC/CWRU and CHOP). Age-matched healthy controls will also be recruited for an MRI scan. If successful, the proposed studies will support use of these multimodal MRI biomarkers as outcome measures and/or high-risk subject enrichment for future clinical trials for ARPKD patients.
- Keywords
- MRI, ARPKD, Pediatric, Ciliopathy, Biomarker
- Medical subject headings
- Polycystic Kidney, Autosomal Recessive, Ciliopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Early CKD Patients | eGFR > or = to 90 ml/min/1.73m2 | |
| Mild CKD Patients | eGFR 60-89 ml/min/1.73m2 | |
| Moderate CKD Patients | eGFR 30-59 ml/min/1.73m2 | |
| Healthy Controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnostic performance (AUROC, sensitivity, specificity) of the multimodal MRI assessments MRF (mean kidney T1 and T2), ASL (mean kidney perfusion), and MRE (mean kidney stiffness), alone or in combination to differentiate the 4 study cohorts
Measured: 3 Years
The relationship between the imaging biomarkers, MRF (mean kidney T1 and T2), ASL (mean kidney perfusion), and MRE (mean kidney stiffness) alone or in combination, to baseline and change in measured GFR over 3 years in the 3 ARPKD cohorts
Measured: 3 Years
The level of agreement between breath-hold and free breathing kidney MRF assessments in the 4 cohorts
Measured: 3 Years
Secondary outcomes (2)
Repeatability of multimodal MRI assessments in ARPKD and healthy control subjects
Measured: 3 years
Reproducibility of findings at the two study sites
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 posted1 Oct 2025
- Study start12 Dec 2024
- Primary completion28 Feb 2029 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Autosomal Recessive Polycystic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Dell, The Cleveland Clinic
- Investigators
- Katherine M Dell, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201025
- Sponsor's protocol ID
- 24-088
- Other IDs
- 2R01DK114425
- Acronym
- IMAGE-ARPKD
- Status last verified
- Nov 2025
- First submitted
- 23 Sep 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
MacAskill CJ, Kretzler ME, Parsons A, Gange V, Hach J, Larson S, Zhu Y, Perino J, Farr S, Markley M, Pritts N, Perera-Gonzalez M, Clark HA, Kuehn B, Liu KC, Yu X, Ma D, Chen Y, Flask CA, Dell KM. Multimodal Magnetic Resonance Imaging Assessments of Kidney Disease Severity in Autosomal Recessive Polycystic Kidney Disease. Kidney Int Rep. 2024 Sep 12;9(12):3592-3595. doi: 10.1016/j.ekir.2024.09.006. eCollection 2024 Dec. No abstract available.
PubMed 39698366MacAskill CJ, Markley M, Farr S, Parsons A, Perino JR, McBennett K, Kutney K, Drumm ML, Pritts N, Griswold MA, Ma D, Dell KM, Flask CA, Chen Y. Rapid B1-Insensitive MR Fingerprinting for Quantitative Kidney Imaging. Radiology. 2021 Aug;300(2):380-387. doi: 10.1148/radiol.2021202302. Epub 2021 Jun 8.
PubMed 34100680MacAskill CJ, Erokwu BO, Markley M, Parsons A, Farr S, Zhang Y, Tran U, Chen Y, Anderson CE, Serai S, Hartung EA, Wessely O, Ma D, Dell KM, Flask CA. Multi-parametric MRI of kidney disease progression for autosomal recessive polycystic kidney disease: mouse model and initial patient results. Pediatr Res. 2021 Jan;89(1):157-162. doi: 10.1038/s41390-020-0883-9. Epub 2020 Apr 13.
PubMed 32283547
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Assessments of ARPKD Kidney Disease Progression
- ClinicalTrials.gov ID
- NCT07201025
- Acronym / sponsor ID
- IMAGE-ARPKD / 24-088
- Keywords
- MRI, ARPKD, Pediatric, Ciliopathy, Biomarker
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 1 Oct 2025 (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.
Autosomal Recessive Polycystic Kidney Disease (ARPKD) is a potentially lethal genetic disorder for which there are currently no disease specific treatments. Clinical trials have been limited by the absence of robust measures of disease progression. The overall goal of this 5 year NIH-funded prospective, observational multicenter study conducted at CC (primary site) and Children's Hospital of Philadelphia (CHOP) (collaborating site) is establish a set of rapid, quantitative, and reproducible novel kidney MRI measures applicable to standard clinical MRI scanners, which could serve as potential biomarkers to measure response to therapy in patients across the disease spectrum and all ages.
The investigators will recruit a total of 45 ARPKD patients and 15 healthy controls at the the two sites . All subjects will be > or = 6yrs old with no contraindications to undergoing MRI (non contrast). ARPKD subjects will be recruited into one of 3 cohorts based on their estimated glomerular filtration rate (eGFR): early CKD (eGFR> or =90ml/min/1.73m2), mild CKD (60-89ml/min/1.73m2) and moderate CKD (30-59ml/min/1.73m2). For ARPKD subjects, participation will last 3 years and consist of a baseline and 3 subsequent annual visits. Healthy controls will only have 1 study visit. Study visits for all participants will include collection of clinical and demographic data, clinical blood and urine tests (E.g. serum creatinine) and MRI imaging. ARPKD (but not healthy subjects) will also undergo a measured GFR test (iohexol clearance) to accurately assess their kidney function.
Detailed description
Autosomal Recessive Polycystic Kidney Disease (ARPKD) is a potentially lethal genetic disorder that affects approximately 1/20,000 children and shares common cellular pathophysiology with other cystic kidney diseases, including Autosomal Dominant PKD (ADPKD). The genetics, pathology and clinical features of ARPKD, however, are distinct from ADPKD. In ARPKD, diffuse fusiform dilatations of the collecting tubules ("microcysts") predominate rather than the macrocysts seen in ADPKD. ARPKD kidneys may be very large at presentation, but, unlike ADPKD, actually stabilize in size as normal parenchyma is replaced by cysts and progressive fibrosis develops. ARPKD morbidity and mortality is significant: 30% of children die as neonates and 40-50% of survivors progress to end-stage kidney disease (ESKD) by age 18. Importantly, there are currently no disease-specific, clinically-available therapies for ARPKD and treatment is limited to chronic kidney disease (CKD) management. Several novel therapies have shown promise in ARPKD animal models. Unfortunately, there are currently no reliable clinical measures of ARPKD progression that show changes over a several year period of a clinical trial except in the most severely affected young children, creating a roadblock for implementing clinical trials for ARPKD therapies, especially in patients with less advanced disease.
Conventional endpoints for CKD progression, e.g., 50% decline in estimated glomerular filtration rate (eGFR) or progression to ESKD have substantial limitations in assessing ARPKD progression. Studies from 2 prospective observational cohorts found that the rates of GFR decline in ARPKD patients was relatively slow but also highly variable. Magnetic Resonance Imaging (MRI) measures of total kidney volume (TKV), which have been used successfully in ADPKD trials, are generally not applicable to ARPKD, since TKV does not increase with progressive disease except in severely affected young patients. Therefore, there is a critical need for new, sensitive biomarkers to enable effective clinical trials of therapies for ARPKD. Quantitative MRI techniques, including novel Magnetic Resonance Fingerprinting (MRF), Arterial Spin Labelling (ASL) and Magnetic Resonance Elastography (MRE), have the potential to provide measurable assessments of kidney structure and function. The overall objective of this multi-site study is to establish a set of rapid, quantitative, and reproducible kidney MRI methods applicable to standard clinical MRI scanners, which could serve as potential biomarkers to risk stratify ARPKD patients for clinical trial enrollment and measure response to therapy across the kidney disease spectrum and all ages.
The Aims of this study are (1) to determine the capability of multimodal MRI biomarkers to accurately and repeatably detect and stage ARPKD kidney disease across the full spectrum of disease from early-stage CKD characterized by diffuse kidney cysts (MRF) and reduced kidney perfusion (ASL) to later-stage CKD characterized by progressive kidney fibrosis (MR elastography, MRE); (2) to determine the sensitivity of these MRI biomarkers to detect changes in ARPKD kidney disease progression over time in comparison to gold-standard GFR assessments; and (3) to determine the feasibility of a new free-breathing MRF methodology that would allow infants and young children to be scanned without sedation. For these studies, the investigators will recruit ARPKD patients ≥6 years of age with early, mild, and moderate CKD from across the US for 4 annual multimodal MRI scans and GFR measurements at two collaborating sites (CC/CWRU and CHOP). Age-matched healthy controls will also be recruited for an MRI scan. If successful, the proposed studies will support use of these multimodal MRI biomarkers as outcome measures and/or high-risk subject enrichment for future clinical trials for ARPKD patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Early CKD Patients | – | –eGFR > or = to 90 ml/min/1.73m2 |
| Mild CKD Patients | – | –eGFR 60-89 ml/min/1.73m2 |
| Moderate CKD Patients | – | –eGFR 30-59 ml/min/1.73m2 |
| Healthy Controls | – | – |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Inclusion criteria: ALL SUBJECTS * Ages >6 years old * Able to lay still for 30 minutes in an MRI scanner ARPKD Patients * Clinical and/or genetic diagnosis of ARPKD * eGFR >30ml/min/1.732 performed within the last year Healthy Controls * Otherwise healthy with no known structural or functional kidney disease * Normal documented blood pressure within the last year Exclusion criteria: ALL SUBJECTS * Contraindications to MRI (e.g. metal implants) * Parental/patient refusal to sign an informed consent/ assent form ARPKD Patients * Prior kidney or other solid organ transplant * eGFR <30ml/min/1.732 and/or anticipated dialysis or kidney transplant within the next 3 years Healthy Controls * Systemic diseases known to place patient at risk for kidney disease (e.g. diabetes mellitus) * Obesity (BMI >95th percentile for age for <18 years old, or BMI>30 for adults) * History of prematurity (<32 weeks)
Key inclusion criteria (7 listed)
- ALL SUBJECTS
- Ages >6 years old
- Able to lay still for 30 minutes in an MRI scanner ARPKD Patients
- Clinical and/or genetic diagnosis of ARPKD
- eGFR (creatinine based) >30ml/min/1.732 performed within the last year Healthy Controls
Key exclusion criteria (8 listed)
- ALL SUBJECTS
- Contraindications to MRI (e.g. metal implants)
- Parental/patient refusal to sign an informed consent/ assent form ARPKD Patients
- Prior kidney or other solid organ transplant
- eGFR <30ml/min/1.732 Healthy Controls
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The diagnostic performance (AUROC, sensitivity, specificity) of the multimodal MRI assessments MRF (mean kidney T1 and T2), ASL (mean kidney perfusion), and MRE (mean kidney stiffness), alone or in combination to differentiate the 4 study cohorts
Time frame: 3 Years
The relationship between the imaging biomarkers, MRF (mean kidney T1 and T2), ASL (mean kidney perfusion), and MRE (mean kidney stiffness) alone or in combination, to baseline and change in measured GFR over 3 years in the 3 ARPKD cohorts
Time frame: 3 Years
The level of agreement between breath-hold and free breathing kidney MRF assessments in the 4 cohorts
Time frame: 3 Years
2 secondary outcomes
Repeatability of multimodal MRI assessments in ARPKD and healthy control subjects
Time frame: 3 years
Reproducibility of findings at the two study sites
Time frame: 3 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Background: PubMed 39698366MacAskill CJ, Kretzler ME, Parsons A, Gange V, Hach J, Larson S, Zhu Y, Perino J, Farr S, Markley M, Pritts N, Perera-Gonzalez M, Clark HA, Kuehn B, Liu KC, Yu X, Ma D, Chen Y, Flask CA, Dell KM. Multimodal Magnetic Resonance Imaging Assessments of Kidney Disease Severity in Autosomal Recessive Polycystic Kidney Disease. Kidney Int Rep. 2024 Sep 12;9(12):3592-3595. doi: 10.1016/j.ekir.2024.09.006. eCollection 2024 Dec. No abstract available.
- Background: PubMed 34100680MacAskill CJ, Markley M, Farr S, Parsons A, Perino JR, McBennett K, Kutney K, Drumm ML, Pritts N, Griswold MA, Ma D, Dell KM, Flask CA, Chen Y. Rapid B1-Insensitive MR Fingerprinting for Quantitative Kidney Imaging. Radiology. 2021 Aug;300(2):380-387. doi: 10.1148/radiol.2021202302. Epub 2021 Jun 8.
- Background: PubMed 32283547MacAskill CJ, Erokwu BO, Markley M, Parsons A, Farr S, Zhang Y, Tran U, Chen Y, Anderson CE, Serai S, Hartung EA, Wessely O, Ma D, Dell KM, Flask CA. Multi-parametric MRI of kidney disease progression for autosomal recessive polycystic kidney disease: mouse model and initial patient results. Pediatr Res. 2021 Jan;89(1):157-162. doi: 10.1038/s41390-020-0883-9. Epub 2020 Apr 13.
- Individual participant dataSharing planned: No
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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.
Katherine M Dell, MD principal investigator
The Cleveland Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autosomal Recessive Polycystic Kidney Disease, run by The Cleveland Clinic at 2 sites 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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherine M Dell, MD (216-444-6123, pedsresearch@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The diagnostic performance (AUROC, sensitivity, specificity) of the multimodal MRI assessments MRF (mean kidney T1 and T2), ASL (mean kidney perfusion), and MRE (mean kidney stiffness), alone or in combination to differentiate the 4 study cohorts (time frame: 3 Years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07201025, which also lists 3 linked publications.
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 21 Nov 2025.