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Kidney Week

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Abstract: INFO16

Concentrated Action for Long-Term Safety of SGLT2 Inhibitors in Alport Syndrome: Guard Alport

Session Information

  • Informational Posters
    November 03, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
    Abstract Time: 10:00 AM - 12:00 PM

Category: Genetic Diseases of the Kidneys

  • No subcategory defined

Authors

  • Gross, Oliver, Georg-August-Universitat Gottingen Universitatsmedizin, Gottingen, Niedersachsen, Germany
  • Boeckhaus, Jan, Georg-August-Universitat Gottingen Universitatsmedizin, Gottingen, Niedersachsen, Germany
Description

Many patients with the common genetic disease Alport syndrome (AS) develop renal failure early in life. Therapy with ACE-inhibitors (ACEi) can delay renal failure by years. The nephroprotective effects of SGLT2-inhibitors (SGLT2i) were examined primarily in patients with other causes of CKD, however, whether the use of SGLT2is is safe and effective in patients with AS (and thus a different pathogenesis) has not yet been investigated specifically.
This non-interventional, observational, retrospective study in patients with AS assesses the effect of SGLT2i on disease progression and safety. Main inclusion criteria are confirmed diagnosis of AS and patient’s consent. The primary efficacy endpoint is the intra-individual change in albuminuria at six and/or twelve months after initiation of therapy. Main secondary endpoint will be change in eGFR six or twelve months after initiation of therapy. Safety will be documented by adverse events in questionnaires, including serious adverse events; adverse events of special interest are ketoacidosis, fluid overload, acute kidney failure, genital infections.
The observational study will provide very important data, if treatment of AS with SGLT2is on top of ACEi lowers albuminuria and is safe. Similar to the better response to ACEi therapy observed in AS patients with missense variants, we will also investigate, whether patients with specific variants also respond better to SGLT2i therapy. The study is open to all physicians worldwide, who treat AS patients.
The observational study will help us to better plan the upcoming investigator-initiated, multi-center, double-blinded, Placebo-controlled phase 3 interventional study in children 10 years and older and young adults at early stages of AS, which applied for Government funding and is planned to start in 2023.
Sponsor of the observational study: University Medicine Goettingen, Goettingen, Germany. ClinicalTrials.gov Identifier: NCT02378805

Funding

  • funding by a research grant to J.B. by University Medicine Goettingen (sponsor of the observational study: University Medicine Goettingen, Goettingen, Germany)
Abstract: INFO16

Concentrated Action for Long-Term Safety of SGLT2 Inhibitors in Alport Syndrome: Guard Alport

Session Information

  • Informational Posters
    November 04, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
    Abstract Time: 10:00 AM - 12:00 PM

Category:

  • No subcategory defined

Authors

  • Gross, Oliver, Georg-August-Universitat Gottingen Universitatsmedizin, Gottingen, Niedersachsen, Germany
  • Boeckhaus, Jan, Georg-August-Universitat Gottingen Universitatsmedizin, Gottingen, Niedersachsen, Germany
Description

Many patients with the common genetic disease Alport syndrome (AS) develop renal failure early in life. Therapy with ACE-inhibitors (ACEi) can delay renal failure by years. The nephroprotective effects of SGLT2-inhibitors (SGLT2i) were examined primarily in patients with other causes of CKD, however, whether the use of SGLT2is is safe and effective in patients with AS (and thus a different pathogenesis) has not yet been investigated specifically.
This non-interventional, observational, retrospective study in patients with AS assesses the effect of SGLT2i on disease progression and safety. Main inclusion criteria are confirmed diagnosis of AS and patient’s consent. The primary efficacy endpoint is the intra-individual change in albuminuria at six and/or twelve months after initiation of therapy. Main secondary endpoint will be change in eGFR six or twelve months after initiation of therapy. Safety will be documented by adverse events in questionnaires, including serious adverse events; adverse events of special interest are ketoacidosis, fluid overload, acute kidney failure, genital infections.
The observational study will provide very important data, if treatment of AS with SGLT2is on top of ACEi lowers albuminuria and is safe. Similar to the better response to ACEi therapy observed in AS patients with missense variants, we will also investigate, whether patients with specific variants also respond better to SGLT2i therapy. The study is open to all physicians worldwide, who treat AS patients.
The observational study will help us to better plan the upcoming investigator-initiated, multi-center, double-blinded, Placebo-controlled phase 3 interventional study in children 10 years and older and young adults at early stages of AS, which applied for Government funding and is planned to start in 2023.
Sponsor of the observational study: University Medicine Goettingen, Goettingen, Germany. ClinicalTrials.gov Identifier: NCT02378805

Abstract: INFO16

Concentrated Action for Long-Term Safety of SGLT2 Inhibitors in Alport Syndrome: Guard Alport

Session Information

  • Informational Posters
    November 05, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
    Abstract Time: 10:00 AM - 12:00 PM

Category:

  • No subcategory defined

Authors

  • Gross, Oliver, Georg-August-Universitat Gottingen Universitatsmedizin, Gottingen, Niedersachsen, Germany
  • Boeckhaus, Jan, Georg-August-Universitat Gottingen Universitatsmedizin, Gottingen, Niedersachsen, Germany
Description

Many patients with the common genetic disease Alport syndrome (AS) develop renal failure early in life. Therapy with ACE-inhibitors (ACEi) can delay renal failure by years. The nephroprotective effects of SGLT2-inhibitors (SGLT2i) were examined primarily in patients with other causes of CKD, however, whether the use of SGLT2is is safe and effective in patients with AS (and thus a different pathogenesis) has not yet been investigated specifically.
This non-interventional, observational, retrospective study in patients with AS assesses the effect of SGLT2i on disease progression and safety. Main inclusion criteria are confirmed diagnosis of AS and patient’s consent. The primary efficacy endpoint is the intra-individual change in albuminuria at six and/or twelve months after initiation of therapy. Main secondary endpoint will be change in eGFR six or twelve months after initiation of therapy. Safety will be documented by adverse events in questionnaires, including serious adverse events; adverse events of special interest are ketoacidosis, fluid overload, acute kidney failure, genital infections.
The observational study will provide very important data, if treatment of AS with SGLT2is on top of ACEi lowers albuminuria and is safe. Similar to the better response to ACEi therapy observed in AS patients with missense variants, we will also investigate, whether patients with specific variants also respond better to SGLT2i therapy. The study is open to all physicians worldwide, who treat AS patients.
The observational study will help us to better plan the upcoming investigator-initiated, multi-center, double-blinded, Placebo-controlled phase 3 interventional study in children 10 years and older and young adults at early stages of AS, which applied for Government funding and is planned to start in 2023.
Sponsor of the observational study: University Medicine Goettingen, Goettingen, Germany. ClinicalTrials.gov Identifier: NCT02378805