Clinical Trials Register

Summary
EudraCT Number:	2014-002349-23
Sponsor's Protocol Code Number:	8232-CL-0004
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2014-10-22
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Czechia - SUKL

A.2

EudraCT number

2014-002349-23

A.3

Full title of the trial

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.

Fáze 2, dvojitě zaslepená, randomizovaná, placebem kontrolovaná studie, která hodnotí účinnost a bezpečnost přípravku ASP8232 jako doplňkové léčby k inhibitoru enzymu angiotenzin-konvertázy (ACEi) nebo blokátoru receptoru pro angiotenzin (ARB) při snižování albuminurie u pacientů s Diabetem Typu 2 a chronickým onemocněním ledvin

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A study to evaluate efficacy and safety of ASP8232 as add-on therapy to the standard of care in patients with Type 2 Diabetes and Chronic Kidney Disease.

A.3.2

Name or abbreviated title of the trial where available

ALBUM

A.4.1

Sponsor's protocol code number

8232-CL-0004

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Astellas Pharma Europe BV (APEB)
B.1.3.4	Country	Netherlands
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Astellas Pharma Europe BV
B.4.2	Country	Netherlands
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Astellas Pharma Europe BV
B.5.2	Functional name of contact point	Service Desk - Global Clinical Dev.
B.5.3	Address:
B.5.3.1	Street Address	Sylviusweg 62
B.5.3.2	Town/ city	Leiden
B.5.3.3	Post code	2333 BE
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	+31(0)715455050
B.5.5	Fax number	+31(0)715455501
B.5.6	E-mail	contact@nl.astellas.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	ASP8232
D.3.2	Product code	ASP8232
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ASP8232
D.3.9.2	Current sponsor code	ASP8232
D.3.9.3	Other descriptive name	AS2658232-PH, VAP-823
D.3.9.4	EV Substance Code	SUB91888
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Diabetic nephropathy

E.1.1.1

Medical condition in easily understood language

Diabetic nephropathy is chronic kidney disease or damage that can occur in people with diabetes mellitus.

E.1.1.2

Therapeutic area

Not possible to specify

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.1
E.1.2	Level	PT
E.1.2	Classification code	10061835
E.1.2	Term	Diabetic nephropathy
E.1.2	System Organ Class	10038359 - Renal and urinary disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

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.

E.2.2

Secondary objectives of the trial

1. To evaluate the efficacy of ASP8232 in reducing the 24h urinary albumin excretion rate (AER) in patients with T2DM and CKD at 12 weeks compared to placebo
2. To evaluate the safety and tolerability of ASP8232 in patients with T2DM and CKD
3. To evaluate the pharmacokinetics (PK) of ASP8232 in patients with T2DM and CKD
4. To evaluate pharmacodynamics (PD) of ASP8232 by assessing vascular adhesion protein-1 (VAP-1) plasma concentration and inhibition of VAP-1 activity and total antioxidant status (TAS) in serum

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female subject who is ≥ 18 and ≤ 85 years of age.
2. Subject must have a eGFR (based on the CKD-EPI equation) at screening of ≥ 25 and < 75 mL/min/1.73m2.
3. Subject must have a documented diagnosis of T2DM and received anti-diabetic medication (oral and/or insulin) for at least one year prior to screening.
4. Subject's HbA1c level is < 11.0% (< 97 mmol/mol) at screening.
5. Subject is on a stable therapy with an ACE inhibitor or ARB for at least three months prior to screening.
6. Subject who receives anti-hypertensive treatment, oral anti-diabetic agents and/or vitamin D receptor activators at screening needs to be on XML File Identifier: ZjuTmt+9OsP1UIlNdrypFI92Sng=
Page 10/23 stable therapy for at least three months prior to screening.
7. Subject's UACR is ≥ 200 and ≤ 3000 mg/g in a 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.

E.4

Principal exclusion criteria

1. Subject is on, or previously received, renal replacement therapy (e.g. dialysis or kidney transplantation).
2. Subject has significant 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.
3. Subject’s renal impairment and/or albuminuria is considered to be of other origin than Diabetic Kidney Disease
4. Subject has known (auto-) immune disorder and/or received immunosuppression for more than two weeks, cumulatively, within 12 weeks prior to screening or anticipated need for immuno-suppressive therapy during the study
5. Subject has active urinary tract infection which requires treatment or clinically significant infection at the time of screening or randomization
6. Subject is diagnosed with type 1 diabetes mellitus or diabetes mellitus with unclear etiology.
7. Subject has a sitting systolic blood pressure (SBP) <90 or >160 mmHg and/or a diastolic blood pressure (DBP) >90 mmHg at screening.

E.5 End points

E.5.1

Primary end point(s)

Mean change of log transformed UACR from baseline to end of treatment.

E.5.1.1

Timepoint(s) of evaluation of this end point

As per schedule of assessments described in the protocol.

E.5.2

Secondary end point(s)

• The proportion of subjects with >30%/40%/50% reduction in UACR from baseline to end of treatment
• Mean change of log transformed AER from baseline to end of treatment
• The proportion of subjects with >30%/40%/50% reduction in AER from baseline to end of treatment

E.5.2.1

Timepoint(s) of evaluation of this end point

As per schedule of assessments described in the protocol.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

110

F.4.2.2

In the whole clinical trial

110

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

none

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2015-01-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-12-30

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-03-15

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