Ganagliflozin on the Progression of Kidney Disease in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorHangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

About this trial

This study aims to investigate the impact of adding Ganagliflozin tablets to the current background therapy on preventing the progression of kidney disease in subjects with type 2 diabetes and chronic kidney disease. The efficacy and safety will be evaluated by comparing the effects of Ganagliflozin tablets and placebo tablets added to the current background treatment over 120 weeks

Eligibility criteria

Qualifiers

Male or female individuals aged 18 years and above;

Meets the diagnostic criteria for T2DM;

Meets the diagnostic criteria for CKD, during the screening period(CKD-EPI Formula): eGFR ≥ 30 to < 60 mL/min/1.73m², and UACR is ≥ 30 to < 5000 mg/g; Or eGFR ≥ 60 to < 90 mL/min/1.73m², and UACR is ≥ 300 to < 5000 mg/g ;

HbA1c ≥ 6.5% to ≤ 12%;

Disqualifiers

Patients with type 1 diabetes or other special types of diabetes;

A medical history or clinical evidence indicating that the subjects have other primary kidney diseases and secondary kidney diseases other than type 2 diabetes (including but not limited to lupus nephritis, ANCA-related nephritis);

History of kidney transplantation;

Blood potassium level > 5.5 mmol/L during the screening period.

Trial design

Treatments tested in this trial

  • ganagliflozin
  • Placebo

Treatment groups

1,244 Participants
are divided into 2 treatment groups