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

Официальное название

A Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Effects of Ganagliflozin on the Progression of Kidney Disease in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease

Обзор

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

Подробное описание

A phase IV clinical study on the efficacy and safety of Ganagliflozin in treating patients with type 2 diabetes and chronic kidney disease (multicenter, randomized, double-blind, placebo parallel controlled). 1244 subjects all received a stable dose of ACEi or ARB for at least 4 weeks before enrollment.

Efficacy assessment: Compared with the placebo group, time to the first occurrence of kidney disease progression and the changes in eGFR slope, UACR, and score of KDQOL-36 were evaluated.

Вмешательства

• Препарат ganagliflozin
  50 mg Once daily, 120 weeks
• Препарат Placebo
  50 mg Once daily, 120 weeks

Первичные конечные точки

• The average change in eGFR as measured by the total slope of eGFR from baseline to week 120 [Срок оценки: Baseline to Week 120]

Вторичные конечные точки (6)

• Time to the first occurrence of kidney disease progression [Срок оценки: from baseline to Week 120]
• The proportion of subjects with a total slope of eGFR greater than -3 mL/min/1.73 m²/year from baseline to week 120 [Срок оценки: from baseline to week 120]
• The average change in eGFR as measured by the total slope of eGFR from baseline to week 2 and week 8，from week 2 and week 8 to week 120 [Срок оценки: from baseline to week 2 and week 8，from week 2 and week 8 to week 120]
• The changes in urine albumin-to-creatinine ratio (UACR) at each visit compared to the baseline [Срок оценки: from baseline to week 120]
• Changes in the scores of the Kidney Disease Quality of Life-36 Scale (KDQOL-36) compared to the baseline [Срок оценки: from baseline to week 120]
• Changes in the scores of the European Five-Dimensional Health Scale (EQ-5D-5L) compared to the baseline [Срок оценки: from baseline to week 120]

Критерии участия

Критерии включения

• 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/1.73m\^2, and UACR is ≥ 30 to < 5000 mg/g; Or eGFR ≥ 60 to < 90 mL/min/1.73m\^2, and UACR is ≥ 300 to < 5000 mg/g ;
• HbA1c ≥ 6.5% to ≤ 12%;
• If there are no contraindications or special instructions, all subjects must take a stable dose of ACEi or ARB at least 4 weeks before randomization;

Критерии исключения

• 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.
• New York Heart Association (NYHA) classification of grade IV during the screening period;
• Experienced ketoacidosis, myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack (TIA), hospitalization due to heart failure, or hospitalization due to urinary tract infection or acute kidney injury within 12 weeks before the screening period;
• Receiving ACEi and ARB in combination;
• Receiving mineralocorticoid receptor antagonists (MRA) or direct renin inhibitors (DRI) within 8 weeks before randomization;
• Receiving drugs with immunosuppressive effects (such as cyclophosphamide, cyclosporine A, tacrolimus, etc.) or biological agents (rituximab, belimumab, etc.) during the 12 weeks before the screening period;
• Receiving SGLT-2 inhibitors or GLP-1 receptor agonists within 8 weeks before the screening, or have previously used SGLT-2 inhibitor drugs and discontinued due to poor efficacy.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai sixth People's Hospital — Шанхай

Идентификаторы

NCT: NCT07116928 · HDHYJ-LC-2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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