Health TrialsbyHealthPanel

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

ConditionsT2DM (Type 2 Diabetes Mellitus)CKD - 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • ganagliflozin

    Drug

    50 mg Once daily, 120 weeks

  • Placebo

    Drug

    50 mg Once daily, 120 weeks

Treatment groups

1,244 Participants
are divided into 2 treatment groups
Group A: ganagliflozinExperimental treatment 1 intervention
Group B: placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The average change in eGFR as measured by the total slope of eGFR from baseline to week 120

Time frame
Baseline to Week 120

Secondary outcomes

1

Time to the first occurrence of kidney disease progression

The progression of kidney disease is defined as: 1. maintenance dialysis or 2. receipt of a kidney transplant or 3. sustained decline in eGFR to \< 15 mL/min/1.73m\^2 or 4. a sustained decline of ≥ 40% in eGFR from baseline or 5. doubling of serum creatinine or 6. renal death

Time frame
from baseline to Week 120
2

The proportion of subjects with a total slope of eGFR greater than -3 mL/min/1.73 m²/year from baseline to week 120

Time frame
from baseline to week 120
3

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

Time frame
from baseline to week 2 and week 8，from week 2 and week 8 to week 120
4

The changes in urine albumin-to-creatinine ratio (UACR) at each visit compared to the baseline

Time frame
from baseline to week 120

Other outcomes

1

time to the first occurrence of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for heart failure

Time frame
from baseline to week 120
2

Changes in liver stiffness measurement (LSM) of liver transient elastography

Time frame
from baseline to week 52 and 120
3

change in the staging of diabetic retinopathy measured by non-mydriatic fundus photography

Time frame
from baseline to week 52 and 120
4

Changes in control attenuation index (Cap) of liver transient elastography

Time frame
from baseline to week 52 and 120

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: