higher-grade renal insufficiency, kidney transplant recipients
Conditions
Interventions
Group 1: Patients verum group RENAL LIFECYCLE: Partial body examinations of the kidney (in the iliac fossa) using fMRI (MAGNE-TOM PrismaFit, Siemens Healthcare AG, Erlangen).
Group 2: Patients placebo
Sponsors
Medizinische Universitätsklinik Tübingen, Innere Medizin IV, Abteilung für Diabetologie, Endokrinologie, Nephrologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Participation in the study “The RENAL LIFECYCLE Trial: A RCT to Assess the Effect of Dapagliflozin on Renal and Cardiovascular Out-comes in Patients With Severe CKD” (ClinicalTrials.gov Identifier: NCT05374291) in Tübingen, • written consent from the patient.
Exclusion criteria
Exclusion criteria: • Presence of non-MRI-compatible implants or any type of metal in and on the body, • increased sensitivity to loud noises, • claustrophobia, • obesity with a body weight of >150 kg, • pregnant/breastfeeding women, • limited ability to consent, • patients who do not want to be informed about incidental findings.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quantification of changes in fMRI-based tissue parameters of the kidneys (or transplant kidney) 3 months, 6 months, and 12 months after the start of therapy with dapagliflozin (verum) and comparison with the placebo group (without therapy with dapagliflozin) (endpoint : proportion of patients in whom fMRI-based tissue parameters could correctly differentiate between verum and placebo groups (after unblinding)). | — |
Secondary
| Measure | Time frame |
|---|---|
| • Review of the suitability of fMRI-determined tissue parameters for monitoring the therapeutic success of dapagliflozin (endpoint: correlation of changes in fMRI-determined tissue parameters of the kidneys with the renal endpoints of the RENAL LIFECYCLE study (renal failure) / proportion of patients in whom fMRI-based tissue parameters could be correctly differentiated between responders and non-responders in the verum group (after unblinding)). • Early detection of therapeutic success of dapagliflozin 3 months after start of therapy (endpoint: correlation of changes in fMRI-based tissue parameters 3 months after start of therapy (t1) with the renal endpoints of the RENAL LIFECYCLE study). • Prediction of therapy success before the start of therapy using fMRI-determined tissue parameters of the kidneys (endpoint: correlation of fMRI-based tissue parameters before the start of therapy t0 with the renal endpoints of the RENAL LIFECYCLE study). • Development and evaluation of software algorithms for automated image registration, organ segmentation and multiparametric MRI evaluation of the kidneys. • Proposal of an MR biomarker for monitoring chronic renal failure. | — |
Countries
Germany
Contacts
Public ContactFerdinand Seith
Medizinische Universitätsklinik Tübingen, Radiologie, Diagnostische & Interventionelle Radiologie
Outcome results
None listed