Astellas - 8232-CL-0004 - Chronic Kidney & Diabetes Type 2
Research type
Research Study
Full title
A Phase 2, Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of 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
IRAS ID
165803
Contact name
Tim Reynolds
Contact email
Sponsor organisation
Astellas Pharma Europe B.V. (APEB)
Eudract number
2014-002349-23
Duration of Study in the UK
1 years, 0 months, 28 days
Research summary
This is a multicentre study sponsored by Astellas BV, with approximately 50 sites in Europe and 110 subjects.
Approximately 347 million people suffer from diabetes. Having diabetes doubles the risk of dying, increases the risk for heart disease and stroke, often results in complications such as diabetic neuropathy and retinopathy and the development of chronic kidney disease (CKD) which is known as Diabetic Kidney Disease (DKD). DKD is usually asymptomatic until proteinuria (too much protein in the urine) or kidney failure develops requiring dialysis or kidney transplantation.
The kidney function protecting effects of drugs that interfere with the renin angiotensin system (RAS) indicate that RAS activation contributes to DKD in humans. Drugs that interrupt RAS are used as first-line antihypertensive therapy in the management of DKD with proteinuria. However, due to the limited effects of these drugs, many patients experience loss of renal function despite optimal blood pressure control, suggesting a large unmet need to improve renal dysfunction in these patients.
The study drug ASP8232 is a VAP-1 inhibitor. Plasma VAP-1 activity is shown to be increased in patients with diabetes and findings suggest that the vascular changes seen as a result of increased plasma VAP-1 may cause DKD. Therefore lowering plasma VAP-1 levels using ASP8232, results in a reduction of these vasculature changes and an improvement in DKD.
The purpose of this study is to evaluate the efficacy of ASP8232 (as an addition to standard of care treatment) in reducing urinary albumin/creatine ratio (measure of renal function) in subjects diagnosed with type II diabetes and with CKD but not on dialysis.
This is a double blind placebo controlled study and neither the patient nor the study doctor will know which medication is being given. There will be one active arm with ASP8232 (n=55) and one placebo arm (n=55).
REC name
South Central - Oxford A Research Ethics Committee
REC reference
14/SC/1347
Date of REC Opinion
18 Dec 2014
REC opinion
Further Information Favourable Opinion