Impact of dapagliflozin for the regulation of immunological activity in Membranous Nephropathy

Conditions

Membranous Nephropathy

Brief summary

Change in anti-PLA2R1 antibody titer (ELISA titer in RU/mL) from baseline to 6 months after dapagliflozin treatment compared with pretreatment antibody titer

Detailed description

Change in proteinuria (in g/g) from baseline to 6 months after dapagliflozin treatment (under stable antiproteinuric treatment), Change in albumin levels (in g/L) from baseline to 6 months after dapagliflozin treatment (under stable antiproteinuric treatment), Change in glomerular filtration rate (in ml/min/1.73m2) from baseline to 6 months after dapagliflozin treatment (under stable antiproteinuric treatment), Need for Rituximab treatment for clinical relapse (according to KDIGO 2021 guidelines and French 2022 guidelines), Change in cytokine profile from baseline to 6 months after dapagliflozin treatment (analysis of 9 cytokines: IL-12p70; IL-17A; IL-4; IL-5; IL-1β; IL-10; IFNα; IL-6 and IFNγ), Clinical and biological tolerance of dapagliflozin treatment

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Interventions

DRUGForxiga 10 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change in anti-PLA2R1 antibody titer (ELISA titer in RU/mL) from baseline to 6 months after dapagliflozin treatment compared with pretreatment antibody titer	—

Secondary

Measure	Time frame
Change in proteinuria (in g/g) from baseline to 6 months after dapagliflozin treatment (under stable antiproteinuric treatment), Change in albumin levels (in g/L) from baseline to 6 months after dapagliflozin treatment (under stable antiproteinuric treatment), Change in glomerular filtration rate (in ml/min/1.73m2) from baseline to 6 months after dapagliflozin treatment (under stable antiproteinuric treatment), Need for Rituximab treatment for clinical relapse (according to KDIGO 2021 guidelines and French 2022 guidelines), Change in cytokine profile from baseline to 6 months after dapagliflozin treatment (analysis of 9 cytokines: IL-12p70; IL-17A; IL-4; IL-5; IL-1β; IL-10; IFNα; IL-6 and IFNγ), Clinical and biological tolerance of dapagliflozin treatment	—

Measure

Time frame

Change in proteinuria (in g/g) from baseline to 6 months after dapagliflozin treatment (under stable antiproteinuric treatment), Change in albumin levels (in g/L) from baseline to 6 months after dapagliflozin treatment (under stable antiproteinuric treatment), Change in glomerular filtration rate (in ml/min/1.73m2) from baseline to 6 months after dapagliflozin treatment (under stable antiproteinuric treatment), Need for Rituximab treatment for clinical relapse (according to KDIGO 2021 guidelines and French 2022 guidelines), Change in cytokine profile from baseline to 6 months after dapagliflozin treatment (analysis of 9 cytokines: IL-12p70; IL-17A; IL-4; IL-5; IL-1β; IL-10; IFNα; IL-6 and IFNγ), Clinical and biological tolerance of dapagliflozin treatment

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Countries

France

Outcome results

None listed