Overview

This trial is active, not recruiting.

Conditions chronic kidney disease, type 2 diabetes
Treatments asp8232, placebo
Phase phase 2
Sponsor Astellas Pharma Europe B.V.
Start date February 2015
End date October 2016
Trial size 125 participants
Trial identifier NCT02358096, 2014-002349-23, 8232-CL-0004

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
ASP8232 administered once daily
asp8232
oral capsule
(Placebo Comparator)
Placebo administered once daily
placebo
oral capsule

Primary Outcomes

Measure
Mean change of log transformed urinary albumin to creatinine ratio (UACR) from baseline to end of treatment
time frame: Baseline and end of treatment (12 weeks)

Secondary Outcomes

Measure
Proportion of subjects with either >30% or >40% or >50% reduction in UACR from baseline to end of treatment
time frame: Baseline and end of treatment (12 weeks)
Mean change of log transformed albumin excretion rate (AER) from baseline to end of treatment
time frame: Baseline and end of treatment (12 weeks)
Proportion of subjects with either >30% or >40% or >50% reduction in AER from baseline to end of treatment
time frame: Baseline and end of treatment (12 weeks)

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

Inclusion Criteria: - Subject must have an estimated glomerular filtration rate (eGFR) ) >=25 and <75 ml/min/1.73m2. - Subject must have a documented diagnosis of T2DM and received anti-diabetic medication (oral and/or parenteral) for at least 1 year prior to screening - Subject's glycated hemoglobin (HbA1c) level is < 11.0% (<97 mmol/mol) at screening. - Subject is on a stable therapy with an angiotensin-converting-enzyme (ACE) inhibitor or angiotensin receptor blockers (ARB) for at least 3 months prior to screening. - Subject who receives anti-hypertensive treatment, non-insulin anti-diabetic agents and/or vitamin D receptor activators at screening needs to be on stable therapy for at least 3 months prior to screening. Subjects on insulin therapy may have the insulin type/dose/schedule adjusted even during the 3 months prior to screening. - If the subject has been subjected to specific dietary interventions then this has to be stable over the past 3 months prior to screening visit. - Subject's UACR is ≥ 200 and ≤ 3000 mg/g in a first morning void (FMV) sample at screening AND the geometric mean UACR of all FMV samples at visit 4 and at visit 5 is ≥ 200 and ≤ 3000 mg/g AND the UACR in at least 3 FMV samples at visit 4 and visit 5 is ≥ 200 mg/g. Exclusion Criteria: - Subject is on, or previously received, renal replacement therapy (e.g. dialysis or kidney transplantation). - Subject has obstructive uropathy or other causes of renal impairment not related to parenchymal renal disorder and/or disease of the kidney; or subject currently has or has had in the past renal disease secondary to malignancy. - Subject's renal impairment and/or albuminuria is considered to be of other origin than Diabetic Kidney Disease. - Subject has known (auto-) immune disorder and/or received immunosuppression for more than 2 weeks, cumulatively, within 12 weeks prior to screening or anticipated need for immuno-suppressive therapy during the study. - Subject has active urinary tract infection which requires treatment or clinically significant infection at the time of screening or randomization - Subject is diagnosed with type 1 diabetes mellitus or diabetes mellitus with unclear etiology. - Subject has a sitting systolic blood pressure (SBP) <90 or >160 mmHg and/or a diastolic blood pressure (DBP) >90 mmHg at screening.

Additional Information

Official 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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Astellas Pharma Inc.