NCT05682053

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 27, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

March 27, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2024

Completed
Last Updated

December 5, 2025

Status Verified

November 1, 2025

Enrollment Period

10 months

First QC Date

December 27, 2022

Last Update Submit

November 28, 2025

Conditions

Keywords

medullary sponge kidneykidney stonemultiparametric MRImedullary function

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day 0

Secondary Outcomes (1)

  • Comparaison of ADC value measured by diffusion-weighted MRI beetween medullary sponge kidney patients and controls.

    Day 0

Other Outcomes (7)

  • Comparaison of T1 Value measured by T1 mapping MRI between medullary sponge kidney patients and controls.

    Day 0

  • Comparaison of T2 Value measured by T2 mapping MRI between medullary sponge kidney patients and controls.

    Day 0

  • In medullary sponge kidney patients, evaluation of the association between kidney function and : - ADC value measured by diffusion-weighted MRI - T1 Value measured by T1 mapping MRI - T2 Value measured by T2 mapping MRI

    Day 0

  • +4 more other outcomes

Study Arms (2)

patients with medullary sponge kidney

OTHER

Patients with medullary sponge kidney attending medical consultation

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.

Diagnostic Test: Multiparametic MRI

Interventions

Multiparametic MRIDIAGNOSTIC_TEST

patients will have a Multiparametric MRI

Patients with glomerular filtration rate > 60 mL/min/1.73m2 without kidney stonepatients with medullary sponge kidney

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • legal protection measure (guardianship, curatorship)
  • Deprived of liberty by a judicial or administrative decision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Edouard Herriot

Lyon, 69003, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Medullary Sponge KidneyKidney Calculi

Condition Hierarchy (Ancestors)

Kidney Diseases, CysticKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesNephrolithiasisUrolithiasisUrinary CalculiCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2022

First Posted

January 12, 2023

Study Start

March 27, 2023

Primary Completion

January 8, 2024

Study Completion

January 8, 2024

Last Updated

December 5, 2025

Record last verified: 2025-11

Locations