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OpenTrials
Active, Not Recruiting

NCT Number: NCT06226896

Effects of Dapagliflozin on Progression of Alport Syndrome

Recently, a series of large clinical trials have confirmed the cardio-renal protective effects of sodium-glucose cotransporter 2 (SGLT2) inhibitors. but few patients with hereditary nephritis were included in these studies. This study is to evaluate the effects of dapagliflozin on slowing kidney disease progression in patients with Alport syndrome.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Alport Syndrome Collagen Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephritis Nephritis, Hereditary Skin and Connective Tissue Diseases Urogenital Abnormalities Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Jinling Hospital

Nanjing, Jiangsu, 210016, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologic or genetic confirmation of Alport syndrome;
  • eGFR ≥ 30 ml/min/1.72m2;
  • Proteinuria > 0.5 g/24 h;
  • Use of an ACE inhibitor or ARB, dose stable for more than 4 weeks;

Exclusion criteria

  • Concurrence of other types of kidney disease;
  • type 1 or type 2 diabetes;
  • use of other types of sodium-glucose cotransporter 2 inhibitors within the month prior to enrollment, or prior allergy to such drugs;
  • ACEI combined with ARB, or direct renin inhibitors, aldosterone receptor antagonists;
  • Uncontrolled hypertension (blood pressure greater than 160/90 mmHg during screening);
  • Patients undergoing renal transplantation or maintenance dialysis treatment;
  • Coexist with other serious and/or unstable diseases, such as serious cardiovascular diseases, respiratory diseases, liver diseases or neuropsychiatric diseases;
  • Patients who are participating in clinical trials of other drugs;
  • Pregnant or lactating women, or patients who do not want to receive contraception.

Treatment and study plan

Dapagliflozin 10mg Tab

Drug

Dapagliflozin 10mg daily plus RAS inhibitor

Other names: Dapagliflozin

Primary outcomes

  1. Change of eGFR

    Time frame: 24 months

    The change of eGFR from baseline after 24 months of treatment

Secondary outcomes

  1. Change of proteinuria

    Time frame: 24 months

    The change of proteinuria from baseline after 24 months of treatment

  2. Progression of kidney disease

    Time frame: 24 months

    The incidence of doubling of serum creatinine, a sustained ≥40% eGFR decline from baseline, or end-stage kidney disease after treatment

Other outcomes

  1. Change of eGFR in different subgroups

    Time frame: 24 months

    The change of eGFR from baseline in patients with different phenotype -genotype after treatment

  2. Change of proteinuria in different subgroups

    Time frame: 24 months

    The change of proteinuria from baseline in patients with different phenotype -genotype after treatment

Sponsors and collaborators

Lead sponsor

Nanjing University School of Medicine

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2024
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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