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

Phase 2

Completed

• Conditions: Chronic Kidney Disease; Type 2 Diabetes
• Interventions: Drug: Placebo; Drug: ASP8232

• Registration Number: NCT02358096
• Lead Sponsor: Astellas Pharma Europe B.V.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-03
• Study First Submitted QC: 2015-02-03
• Study First Posted: 2015-02-06
• Study Start: 2015-03-17
• Primary Completion: 2016-10-26
• Study Completion: 2017-03-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo administered once daily
ASP8232	ASP8232	ASP8232 administered once daily

Primary Outcome Measures

Name	Time	Method
Mean change of log transformed urinary albumin to creatinine ratio (UACR) from baseline to end of treatment	Baseline and end of treatment (12 weeks)

Secondary Outcome Measures

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

Trial Locations

Locations (57)

Site CZ42002; 🇨🇿 Brno, Czechia

Site CZ42003; 🇨🇿 Ceské Budejovice, Czechia

Site CZ42001; 🇨🇿 Prague 4, Czechia

Site CZ42005; 🇨🇿 Praha 10, Czechia

Site CZ42004; 🇨🇿 Praha 9, Czechia

Site DK45016; 🇩🇰 Copenhagen, Denmark

Site DK45004; 🇩🇰 Gentofte, Denmark

Site DK45001; 🇩🇰 Herlev, Denmark

Site DK45002; 🇩🇰 Hillerød, Denmark

Site DK45007; 🇩🇰 Holsterbro, Denmark

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