A Study to Evaluate ASP8232 as Add-On Therapy to Angiotensin Converting Enzyme Inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) in Reducing Albuminuria in Patients With Type 2 Diabetes and Chronic Kidney Disease
NCT02358096 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 125
Last updated 2024-10-31
Summary
The purpose of this study is to evaluate the efficacy of ASP8232 in reducing Urinary Albumin to Creatinine Ratio (UACR) in subjects with Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD) at 12 weeks compared to placebo.
Conditions
Interventions
- DRUG
-
ASP8232
oral capsule
- DRUG
-
oral capsule
Sponsors & Collaborators
-
Astellas Pharma Europe B.V.
lead INDUSTRY
Principal Investigators
-
Executive Director · Astellas Pharma Europe B.V.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-03-17
- Primary Completion
- 2016-10-26
- Completion
- 2017-03-15
Countries
- Czechia
- Denmark
- Germany
- Hungary
- Italy
- Netherlands
- Poland
- Spain
- United Kingdom
Study Locations
More Related Trials
-
EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin)
NCT06531824 ·Status: RECRUITING ·Phase: PHASE3
-
Atorvastatin and Alkali Therapy in Patients With Autosomal Dominant Polycystic Kidney Disease
NCT05870007 ·Status: ENROLLING_BY_INVITATION ·Phase: PHASE2
-
Proteomic Prediction and Renin Angiotensin Aldosterone System Inhibition Prevention Of Early Diabetic nephRopathy In TYpe 2 Diabetic Patients With Normoalbuminuria
NCT02040441 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
To Determine the Effects of Avosentan on Doubling of Serum Creatinine, End Stage Renal Disease and Death in Diabetic Nephropathy
NCT00120328 ·Status: TERMINATED ·Phase: PHASE3
-
Effect of Renin-angiotensin System Blockers on Glomerular Filtration Rate in Patients With Hypertension, Type 2 Diabetes With Normoalbuminuria
NCT01500590 ·Status: UNKNOWN ·Phase: PHASE4
-
A Study to Assess the Effect of ASP1585 on Pharmacokinetics of Enalapril in Healthy Volunteers
NCT01115946 ·Status: COMPLETED ·Phase: PHASE1
-
Angiotensin-converting-enzyme (ACE) Inhibitors in Hemodialysis
NCT00985322 ·Status: COMPLETED ·Phase: PHASE3
-
ACEi ARB Withdrawal in CKD Patients
NCT03957161 ·Status: WITHDRAWN ·Phase: NA
-
Optimalization of Nephroprotection Using Agents Inhibiting Renin-Angiotensin-Aldosterone System
NCT00528385 ·Status: COMPLETED ·Phase: NA
-
Study to Evaluate the Efficacy of ASP1128 (MA-0217) in Subjects at Risk for Acute Kidney Injury (AKI) Following Coronary Artery Bypass Graft (CABG) and/or Valve Surgery
NCT03941483 ·Status: COMPLETED ·Phase: PHASE2
-
Spironolactone for Reducing Proteinuria in Diabetic Nephropathy
NCT00498537 ·Status: COMPLETED ·Phase: NA
-
Effect of Enalapril and Losartan Association Therapy on Proteinuria and Inflammatory Biomarkers in Diabetic Nephropathy: a Clinical Trial on Type 2 Diabetes Mellitus
NCT00419835 ·Status: COMPLETED ·Phase: PHASE4
-
Preventing Microalbuminuria in Type 2 Diabetes
NCT00503152 ·Status: COMPLETED ·Phase: PHASE3
-
Mineralocorticoid Receptor Antagonists in End Stage Renal Disease
NCT01691053 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of Lorundrostat in Addition to Sodium-Glucose Cotransporter-2 Inhibitors (SGLT2i) in Subjects With Hypertension and Chronic Kidney Disease (CKD) With Albuminuria
NCT06150924 ·Status: COMPLETED ·Phase: PHASE2
-
Reducing Residual Albuminuria in Subjects With Diabetes and Nephropathy With Atrasentan
NCT01424319 ·Status: COMPLETED ·Phase: PHASE2
-
Spironolactone Safety in Dialysis Patients
NCT00328809 ·Status: WITHDRAWN ·Phase: PHASE4
-
Safety of Add on Aliskiren to Angiotensin Converting Enzyme Inhibitor (ACEI) and Angiotensin I Receptor Blocker (ARB) Treatment in Type 2 Diabetes With Nephropathy
NCT00949351 ·Status: UNKNOWN ·Phase: PHASE4
-
Eplerenone, ACE Inhibition and Albuminuria
NCT00315016 ·Status: COMPLETED ·Phase: PHASE2
-
Mineralocorticoid Receptor Antagonism Clinical Evaluation in Atherosclerosis Trial
NCT02169089 ·Status: COMPLETED ·Phase: PHASE4
-
L-Arginine and Spironolactone Trial in Dialysis-Dependent ESRD
NCT01855334 ·Status: WITHDRAWN ·Phase: PHASE4
-
Effect of ACE-inhibitors on Aortic Stiffness in Elderly Patients With Chronic Kidney Disease
NCT00874432 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy of Two Year of RAAS Alone or in Combination With Spironolactone Therapy
NCT03502031 ·Status: UNKNOWN ·Phase: PHASE4
-
TreatIng Microalbuminuria Over 24 Weeks in Subjects With or Without Type 2 Diabetes or HYpertension
NCT05268926 ·Status: TERMINATED ·Phase: PHASE2
-
Safety and Cardiovascular Efficacy of Hydralazine and Isosorbide Dinitrate in Dialysis-Dependent ESRD
NCT02228408 ·Status: COMPLETED ·Phase: PHASE4