Medullary Sponge KidneyMICARINCT05682053
Multiparametric Magnetic Resonance Imaging (MRI) in Medullary Sponge Kidney
A study testing Multiparametic MRI in people with Medullary Sponge Kidney, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Background : Medullary sponge kidney disease is a congenital disorder caracterised by tubular ectasia and cystic dilatation of the collecting ducts in the pericalyceal region of the renal pyramids, which can lead to nephrolithiasis and frequently associated with impaired tubular function such as distal renal tubular… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medullary Sponge Kidney
- What is being tested?
- Multiparametic MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 27 Mar 2023to 8 Jan 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- medullary sponge kidney attending medical consultation
- Patients with glomerular filtration rate > 60 mL/min/1.73m2 without kidney stone
- consent signed
- effective contraceptive method for women
- affiliated to social insurance scheme
Who cannot join
- kidney transplant
- polycystic kidney diseases
- Chronic kidney disease (GFR < 60 mL/min/1,73m² )
- MRI contraindications (claustrophobia, pacemaker, cardioverter defibrillators implantable, mechanical heart valve non MRI-compatible)
- Weight> 130 kg
- pregnancy
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- legal protection measure (guardianship, curatorship)
- Deprived of liberty by a judicial or administrative decision
- subject participating in another research that may interfere with the research and including an exclusion period still in progress at inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multiparametric MRI Imaging of Medullary Sponge Kidney
Background :
Medullary sponge kidney disease is a congenital disorder caracterised by tubular ectasia and cystic dilatation of the collecting ducts in the pericalyceal region of the renal pyramids, which can lead to nephrolithiasis and frequently associated with impaired tubular function such as distal renal tubular acidosis.
Read more
The disease knowledge is limited, especially about origin, diagnosis, and physiopathology of the disease.
The disease is associated with impaired tubular function such as distal renal tubular acidosis, hypocitraturia, hypercalciuria, which suggest altered kidney medulla function.
Multiparametric MRI may provide further informations about the physiopathology and help in earlier diagnosis of the medullary sponge kidney.
Objective :
The aim of this study is to test the hypothesis that early kidney medulla function alteration in medullary sponge kidney can be detected and characterised with multiparametric MRI. We are expecting to see in medullary sponge kidney a decreased oxygenation content in BOLD MRI (Blood oxygenation level dependent magnetic resonance imaging), and decreased ADC (Apparent diffusion coefficient) value in the medulla.
Design :
A monocentric prospective case/control study will be conducted in adults with medullary sponge kidney. Controls are adults patients with glomerular filtration rate > 60 mL/min/1.73m2 without kidney stone attending a renal exploration.
After a screening visit, patients included will be evaluated on one day with lithiasis assessment and measurement of glomerular filtration (Urinary collection of the last 24 hours, Urine sample, Blood sample) and they will perform multiparametric magnetic resonance imaging of the kidneys.
- Conditions
- Medullary Sponge Kidney
- Being tested
- Multiparametic MRI
- Keywords
- medullary sponge kidney, kidney stone, multiparametric MRI, medullary function
- Medical subject headings
- Medullary Sponge Kidney, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiparametic MRIDiagnostic test
patients will have a Multiparametric MRI
| Study group | Role | What they receive |
|---|---|---|
| patients with medullary sponge kidney | Other | Patients with medullary sponge kidney attending medical consultation Receives: Diagnostic Test: Multiparametic MRI |
| Patients with glomerular filtration rate > 60 mL/min/1.73m2 without kidney stone | Other | Patients with glomerular filtration rate > 60 mL/min/1.73m2 without kidney stone attending a renal exploration. Receives: Diagnostic Test: Multiparametic MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparaison of R2* values measured by BOLD MRI beetween medullary sponge kidney patients and controls.
Comparaison of R2* values measured by BOLD MRI between medullary sponge kidney patients and controls.
R2* is related to the level of tissue deoxyhemoglobin, which reflect tissue oxygenation.
Increases in its outcome measure R2* (transverse relaxation rate expressed as per second) correspond to higher deoxyhaemoglobin concentrations and suggest lower oxygenation, whereas decreases in R2* indicate higher oxygenation.
Measured: Day 0
Secondary outcomes (1)
Comparaison of ADC value measured by diffusion-weighted MRI beetween medullary sponge kidney patients and controls.
Diffusion-weighted magnetic resonance imaging (DWI) is a non-invasive method sensitive to local water motion in the tissue, which is particularly sensitive to alterations in the renal interstitium, e.g. during renal fibrosis
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start27 Mar 2023
- Primary completion8 Jan 2024
- Study completion8 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medullary Sponge KidneyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682053
- Sponsor's protocol ID
- 69HCL22_0366
- Other IDs
- 2022-A01467-36
- Acronym
- MICARI
- Status last verified
- Nov 2025
- First submitted
- 27 Dec 2022
- Last updated
- 5 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tournebize C, De Mul A, Abid N, Portefaix A, Pacaud S, Schleef M, Derain-Dubourg L, Rouviere O, Lemoine S. Medullary sponge kidney: in-depth phenotyping for a better understanding of functional and structural abnormalities. J Nephrol. 2025 Nov;38(8):2363-2373. doi: 10.1007/s40620-025-02413-3. Epub 2025 Sep 19.
PubMed 40973923
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiparametric MRI Imaging of Medullary Sponge Kidney
- ClinicalTrials.gov ID
- NCT05682053
- Acronym / sponsor ID
- MICARI / 69HCL22_0366
- Conditions
- Medullary Sponge Kidney
- Keywords
- medullary sponge kidney, kidney stone, multiparametric MRI, medullary function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 8 Jan 2024 (actual)
- Study completion
- 8 Jan 2024 (actual)
- First posted
- 12 Jan 2023 (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.
Background :
Medullary sponge kidney disease is a congenital disorder caracterised by tubular ectasia and cystic dilatation of the collecting ducts in the pericalyceal region of the renal pyramids, which can lead to nephrolithiasis and frequently associated with impaired tubular function such as distal renal tubular acidosis.
The disease knowledge is limited, especially about origin, diagnosis, and physiopathology of the disease.
The disease is associated with impaired tubular function such as distal renal tubular acidosis, hypocitraturia, hypercalciuria, which suggest altered kidney medulla function.
Multiparametric MRI may provide further informations about the physiopathology and help in earlier diagnosis of the medullary sponge kidney.
Objective :
The aim of this study is to test the hypothesis that early kidney medulla function alteration in medullary sponge kidney can be detected and characterised with multiparametric MRI. We are expecting to see in medullary sponge kidney a decreased oxygenation content in BOLD MRI (Blood oxygenation level dependent magnetic resonance imaging), and decreased ADC (Apparent diffusion coefficient) value in the medulla.
Design :
A monocentric prospective case/control study will be conducted in adults with medullary sponge kidney. Controls are adults patients with glomerular filtration rate > 60 mL/min/1.73m2 without kidney stone attending a renal exploration.
After a screening visit, patients included will be evaluated on one day with lithiasis assessment and measurement of glomerular filtration (Urinary collection of the last 24 hours, Urine sample, Blood sample) and they will perform multiparametric magnetic resonance imaging of the kidneys.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with medullary sponge kidney | Other | Diagnostic Test: Multiparametic MRIPatients with medullary sponge kidney attending medical consultation |
| Patients with glomerular filtration rate > 60 mL/min/1.73m2 without kidney stone | Other | Diagnostic Test: Multiparametic MRIPatients with glomerular filtration rate > 60 mL/min/1.73m2 without kidney stone attending a renal exploration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- medullary sponge kidney attending medical consultation
- Patients with glomerular filtration rate > 60 mL/min/1.73m2 without kidney stone
- consent signed
- effective contraceptive method for women
- affiliated to social insurance scheme
Key exclusion criteria (9 listed)
- kidney transplant
- polycystic kidney diseases
- Chronic kidney disease (GFR < 60 mL/min/1,73m² )
- MRI contraindications (claustrophobia, pacemaker, cardioverter defibrillators implantable, mechanical heart valve non MRI-compatible)
- Weight> 130 kg
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 |
|---|---|---|
| Multiparametic MRIpatients will have a Multiparametric MRI | Diagnostic test | Patients with glomerular filtration rate > 60 mL/min/1.73m2 without kidney stone, patients with medullary sponge kidney |
Primary outcome
Comparaison of R2* values measured by BOLD MRI beetween medullary sponge kidney patients and controls.
Time frame: Day 0
Comparaison of R2* values measured by BOLD MRI between medullary sponge kidney patients and controls. R2* is related to the level of tissue deoxyhemoglobin, which reflect tissue oxygenation. Increases in its outcome measure R2* (transverse relaxation rate expressed as per second) correspond to higher deoxyhaemoglobin concentrations and suggest lower oxygenation, whereas decreases in R2* indicate higher oxygenation.
1 secondary outcome
Comparaison of ADC value measured by diffusion-weighted MRI beetween medullary sponge kidney patients and controls.
Time frame: Day 0
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 5 Dec 2025.
- Results publication: PubMed 40973923Tournebize C, De Mul A, Abid N, Portefaix A, Pacaud S, Schleef M, Derain-Dubourg L, Rouviere O, Lemoine S. Medullary sponge kidney: in-depth phenotyping for a better understanding of functional and structural abnormalities. J Nephrol. 2025 Nov;38(8):2363-2373. doi: 10.1007/s40620-025-02413-3. Epub 2025 Sep 19.
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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 Multiparametic MRI in people with Medullary Sponge Kidney, run by Hospices Civils de Lyon at 1 site in France.
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 5 inclusion and 9 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 5 Dec 2025. 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 France. 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?
Comparaison of R2* values measured by BOLD MRI beetween medullary sponge kidney patients and controls. (time frame: Day 0). 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 NCT05682053, which also lists 1 linked publication.
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 5 Dec 2025.