Clinical Trials List
2014-11-11 - 2018-11-26
Phase III
Terminated8
ICD-10E11.21
Type 2 diabetes mellitus with diabetic nephropathy
ICD-10E11.22
Type 2 diabetes mellitus with diabetic chronic kidney disease
ICD-10E11.29
Type 2 diabetes mellitus with other diabetic kidney complication
ICD-10E13.21
Other specified diabetes mellitus with diabetic nephropathy
ICD-10E13.22
Other specified diabetes mellitus with diabetic chronic kidney disease
ICD-10E13.29
Other specified diabetes mellitus with other diabetic kidney complication
ICD-9250.40
Diabetes with renal manifestations, Type II [non-insulin dependent type][NIDDM type][adult-onset type] or unspecified type ,not stated as uncontrolled
A Randomized, Double-blind, Event-driven, Placebo-controlled, Multicenter Study of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Subjects With Type 2 Diabetes Mellitus and Diabetic Nephropathy
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
Janssen Research & Development, LLC
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 黎思源 Division of Nephrology
- Chih-Ching Lin Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Ching-Chu Chen Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 傅家保 Division of Endocrinology
- TUNG-MIN YU Division of Nephrology
- JUN-SING WANG Division of Endocrinology
- CHENG-HSU CHEN Division of Nephrology
- 林時逸 Division of Endocrinology
- 李佳霖 Division of Endocrinology
- I-TE LEE Division of Endocrinology
- 李昂澤 Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Hung-Chun CHEN Division of Nephrology
- 黃道揚 Division of Nephrology
- 陳苓怡 Division of Nephrology
- 郭美娟 Division of Nephrology
- 洪啟智 Division of Nephrology
- Yi wen chiu Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Primary Composite Endpoint of Doubling of Serum Creatinine (DoSC), End-stage Kidney Disease (ESKD), and Renal or Cardiovascular (CV) Death [ Time Frame: Up to 4.6 years ]
Primary composite endpoint is the composite of DoSC, ESKD, and renal or CV death. DoSC: from baseline average determination (sustained and confirmed by repeat central laboratory measure after at least 30 days and preferably within 60 days). ESKD: as initiation of maintenance dialysis for at least 30 days, or renal transplantation, or an estimated glomerular filtration rate (eGFR) value of less than (<)15 milliliters per minute per 1.73 square meter (mL/min/1.73 m^2) (sustained and confirmed by repeat central laboratory measure after at least 30 days and preferably within 60 days). Renal death: death in participants who had reached ESKD, died without initiating renal replacement therapy, and no other cause of death was determined via adjudication. Adjudication of these events by Endpoint Adjudication Committee (EAC) was performed in blinded fashion. Event rate estimated based on time to first occurrence of primary composite endpoint are presented.
Secondary Outcome Measures :
Composite Endpoint of CV Death and Hospitalized Heart Failure (HHF) [ Time Frame: Up to 4.6 years ]
The composite endpoint included CV death and HHF. CV death included death due to myocardial infarction (MI), stroke, heart failure, sudden death, death during a CV procedure or as a result of procedure-related complications, or death due to other CV causes. For analytic purposes, undetermined causes of death were considered CV deaths. In determining whether a death event was CV in nature, the EAC took into consideration both the proximate and underlying causes. Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of the composite endpoint of CV death and HHF are presented.
Major Adverse Cardiac Event (MACE) [ Time Frame: Up to 4.6 years ]
The composite endpoint included CV death, non-fatal MI, and non-fatal stroke (that is, 3-point MACE). Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of MACE are presented.
Hospitalized Heart Failure (HHF) [ Time Frame: Up to 4.6 years ]
Adjudication of these events by the Endpoint Adjudication Committee (EAC) was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of hospitalized heart failure are presented.
Renal Composite Endpoint [ Time Frame: Up to 4.6 years ]
The renal composite endpoint included composite of DoSC, ESKD and Renal death. DoSC: from the baseline average determination (sustained and confirmed by repeat central laboratory measure after at least 30 days and preferably within 60 days). ESKD: initiation of maintenance dialysis for at least 30 days, or renal transplantation, or an eGFR value of <15 mL/min/1.73 m^2 (sustained and confirmed by repeat central laboratory measure after at least 30 days and preferably within 60 days). Renal death: death in participants who have reached ESKD, died without initiating renal replacement therapy, and no other cause of death was determined via adjudication. Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of the renal composite endpoint are presented.
Cardiovascular (CV) Death [ Time Frame: Up to 4.6 years ]
CV death included death due to MI, stroke, heart failure, sudden death, death during a CV procedure or as a result of procedure-related complications, or death due to other CV causes. For analytic purposes, undetermined causes of death were considered CV deaths. In determining whether a death event was a CV in nature, the EAC took into consideration both the proximate and underlying causes. Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of CV death are presented.
All-cause Mortality [ Time Frame: Up to 4.6 years ]
Adjudication of these events by Endpoint Adjudication Committee (EAC) was performed in a blinded fashion. Event rate estimated based on time to first occurrence of all-cause mortality are presented.
CV Composite Endpoint [ Time Frame: Up to 4.6 years ]
The CV composite endpoint included the CV death, non-fatal MI, non-fatal stroke, hospitalized heart failure, and hospitalized unstable angina. CV death included death due to MI, stroke, heart failure, sudden death, death during a CV procedure or as a result of procedure-related complications, or death due to other CV causes. For analytic purposes, undetermined causes of death were considered CV deaths. In determining whether a death event was a CV in nature, the EAC took into consideration both the proximate and underlying causes. Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of the CV composite endpoint are presented.
Inclution Criteria
Type 2 diabetes mellitus with a hemoglobin A1c (HbA1c) greater than or equal to (>=) 6.5 percent (%) and less than or equal to (<=) 12.0%, with an estimated glomerular filtration rate (eGFR) of >= 30 milliliter (mL)/minute (min)/1.73meter (m)^2 and less than (<) 90 mL/min/1.73 m^2
Participants need to be on a stable maximum tolerated labeled daily dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) for at least 4 weeks prior to randomization
Must have a urine albumin to creatinine ratio (UACR) of greater than (>) 300 milligram (mg)/gram (g) and <= 5000 mg/g
Exclusion Criteria
History of diabetic ketoacidosis or type 1 diabetes mellitus
History of hereditary glucose-galactose malabsorption or primary renal glucosuria
Renal disease that required treatment with immunosuppressive therapy
Known significant liver disease
Current or history of New York Heart Association (NYHA) Class IV heart failure
Blood potassium level >5.5 millimole (mmol)/liter (L) during Screening
The Estimated Number of Participants
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Taiwan
48 participants
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Global
4200 participants
