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

Type 2 Diabetes Clinical Trial

— ALBUM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02358096
• Other study ID #: 8232-CL-0004
• Secondary ID: 2014-002349-23
• Status: Completed
• Phase: Phase 2
• Start date: March 17, 2015
• Est. completion date: March 15, 2017

Study information

• Verified date: November 2018
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: March 15, 2017
• Est. primary completion date: October 26, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Albuminuria
• Chronic Kidney Disease
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Kidney Diseases
• Renal Insufficiency, Chronic
• Type 2 Diabetes

Intervention

Drug:
• ASP8232
oral capsule
• Placebo
oral capsule

Locations

Country	Name	City	State
Czechia	Site CZ42002	Brno
Czechia	Site CZ42003	Ceské Budejovice
Czechia	Site CZ42001	Prague 4
Czechia	Site CZ42005	Praha 10
Czechia	Site CZ42004	Praha 9
Denmark	Site DK45016	Copenhagen
Denmark	Site DK45004	Gentofte
Denmark	Site DK45001	Herlev
Denmark	Site DK45002	Hillerød
Denmark	Site DK45007	Holsterbro
Denmark	Site DK45006	Viborg
Germany	Site DE49004	Berlin
Germany	Site DE49002	Düsseldorf
Germany	Site DE49008	Elsterwerda
Germany	Site DE49003	Heidelberg
Hungary	Site HU36002	Balatonfüred
Hungary	Site HU36010	Budapest
Hungary	Site HU36016	Budapest
Hungary	Site HU36003	Hatvan
Hungary	Site HU36012	Kaposvar
Hungary	Site HU36017	Szekesfehervar
Hungary	Site HU36007	Szigetvar
Hungary	Site HU36005	Szikszó
Hungary	Site HU36018	Veszprem
Italy	Site IT39007	Bergamo
Italy	Site IT39005	Pavia
Italy	Site IT39002	Piacenza
Italy	Site IT39012	Rome
Italy	Site IT39004	Turin
Netherlands	Site NL31001	Dordrecht
Netherlands	Site NL31003	Hoogeveen
Netherlands	Site NL31004	Rotterdam	Zuid-Holland
Poland	Site PL48004	Lodz
Poland	Site PL48008	Lodz
Poland	Site PL48026	Lodz
Poland	Site PL48027	Oswiecim
Poland	Site PL48003	Plock
Poland	Site PL48001	Poznan
Poland	Site PL48022	Radom
Poland	Site PL48006	Rzeszow
Poland	Site PL48005	Sopot
Poland	Site PL48002	Torun
Poland	Site PL48025	Warszawa
Spain	Site ES34001	Barcelona
Spain	Site ES34002	Barcelona
Spain	Site ES34004	Barcelona
Spain	Site ES34005	Barcelona
Spain	Site ES34007	Ciudad Real
Spain	Site ES34006	Lugo
Spain	Site ES34008	Madrid
Spain	Site ES34012	Madrid
Spain	Site ES34010	Majadahonda
Spain	Site ES34003	Palma de Mallorca
United Kingdom	Site GB44004	Burton-on-Trent
United Kingdom	Site GB44001	Chester
United Kingdom	Site GB44005	London
United Kingdom	Site GB44003	South Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Europe B.V.

Countries where clinical trial is conducted

Czechia,  Denmark,  Germany,  Hungary,  Italy,  Netherlands,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Mean change of log transformed albumin excretion rate (AER) from baseline to end of treatment		Baseline and end of treatment (12 weeks)
Secondary	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)

External Links

•   Link to results on the Astellas Clinical Study Results website