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COMPLETEDPHASE2

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

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

NCT02358096•Astellas Pharma Europe B.V.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

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.

Locations (57)

Site CZ42002

Brno, Czechia

Site CZ42003

České Budějovice, Czechia

Site CZ42005

Prague, Czechia

Site CZ42001

Prague, Czechia

Site CZ42004

Prague, Czechia

Site DK45016

Copenhagen, Denmark

Site DK45004

Gentofte Municipality, Denmark

Site DK45001

Herlev, Denmark

Site DK45002

Hillerød, Denmark

Site DK45007

Holsterbro, Denmark

Key Dates

Start Date

March 17, 2015

Primary Completion Date

October 26, 2016

Completion Date

March 15, 2017

Last Updated

October 31, 2024

Enrollment

125

ACTUAL participants

Conditions

Chronic Kidney DiseaseType 2 Diabetes

Interventions

ASP8232

DRUG

Placebo

DRUG

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 31, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)

Feasibility of a Tailored Online Self-compassion Intervention

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

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High Intensity Interval Training and Insulin Sensitivity in Type 2 Diabetes