ALBUM: 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

Sponsor

Astellas Pharma Europe B.V. (Industry)

Overall Status

Completed

CT.gov ID

NCT02358096

Collaborator

(none)

125

Enrollment

Locations

Arms

Actual Duration (Months)

2.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease Type 2 Diabetes	Drug: ASP8232 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

125 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 17, 2015

Actual Primary Completion Date :

Oct 26, 2016

Actual Study Completion Date :

Mar 15, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ASP8232 ASP8232 administered once daily	Drug: ASP8232 oral capsule
Placebo Comparator: Placebo Placebo administered once daily	Drug: Placebo oral capsule

Arm

Intervention/Treatment

Experimental: ASP8232

ASP8232 administered once daily

Drug: ASP8232

oral capsule

Placebo Comparator: Placebo

Placebo administered once daily

Drug: Placebo

oral capsule

Outcome Measures

Primary Outcome Measures

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

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)]
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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site CZ42002	Brno		Czechia
2	Site CZ42003	Ceské Budejovice		Czechia	370 01
3	Site CZ42001	Prague 4		Czechia	140 21
4	Site CZ42005	Praha 10		Czechia	108 00
5	Site CZ42004	Praha 9		Czechia	190 00
6	Site DK45016	Copenhagen		Denmark	2400
7	Site DK45004	Gentofte		Denmark	2820
8	Site DK45001	Herlev		Denmark	2730
9	Site DK45002	Hillerød		Denmark	3400
10	Site DK45007	Holsterbro		Denmark	7500
11	Site DK45006	Viborg		Denmark	8800
12	Site DE49004	Berlin		Germany	13125
13	Site DE49002	Düsseldorf		Germany	40210
14	Site DE49008	Elsterwerda		Germany	04910
15	Site DE49003	Heidelberg		Germany	69115
16	Site HU36002	Balatonfüred		Hungary	8230
17	Site HU36016	Budapest		Hungary	1036
18	Site HU36010	Budapest		Hungary	H-1096
19	Site HU36003	Hatvan		Hungary	H-3000
20	Site HU36012	Kaposvar		Hungary	7400
21	Site HU36017	Szekesfehervar		Hungary	8000
22	Site HU36007	Szigetvar		Hungary	7900
23	Site HU36005	Szikszó		Hungary
24	Site HU36018	Veszprem		Hungary	H- 8200
25	Site IT39007	Bergamo		Italy	24127
26	Site IT39005	Pavia		Italy	27100
27	Site IT39002	Piacenza		Italy	29100
28	Site IT39012	Rome		Italy	00189
29	Site IT39004	Turin		Italy	10141
30	Site NL31004	Rotterdam	Zuid-Holland	Netherlands	3045 PM
31	Site NL31001	Dordrecht		Netherlands	3318 AT
32	Site NL31003	Hoogeveen		Netherlands	7909 AA
33	Site PL48026	Lodz		Poland	90-302
34	Site PL48008	Lodz		Poland	94-048
35	Site PL48004	Lodz		Poland	94-225
36	Site PL48027	Oświęcim		Poland	32-600
37	Site PL48003	Plock		Poland	09-402
38	Site PL48001	Poznan		Poland	61655
39	Site PL48022	Radom		Poland	26-600
40	Site PL48006	Rzeszow		Poland	35-055
41	Site PL48005	Sopot		Poland
42	Site PL48002	Torun		Poland	87-100
43	Site PL48025	Warszawa		Poland	00-660
44	Site ES34001	Barcelona		Spain	08003
45	Site ES34005	Barcelona		Spain	08025
46	Site ES34004	Barcelona		Spain	08035
47	Site ES34002	Barcelona		Spain	08907
48	Site ES34007	Ciudad Real		Spain	13005
49	Site ES34006	Lugo		Spain	27880
50	Site ES34008	Madrid		Spain	28007
51	Site ES34012	Madrid		Spain	28041
52	Site ES34010	Majadahonda		Spain	28222
53	Site ES34003	Palma de Mallorca		Spain	7120
54	Site GB44004	Burton-on-Trent		United Kingdom	DE13 0RB
55	Site GB44001	Chester		United Kingdom	CH2 1UL
56	Site GB44005	London		United Kingdom	SE1 9RT
57	Site GB44003	South Yorkshire		United Kingdom	DN2 5LT