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Safety and Efficacy of Different Oral Doses of BAY94-8862 in Japanese Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy (ARTS-DN Japan)

Primary Purpose

Diabetic Nephropathies

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

BAY94-8862

Placebo

BAY 94-8862

About this trial

This is an interventional treatment trial for Diabetic Nephropathies focused on measuring BAY94-8862, MR antagonist, Diabetic nephropathy, Japanese patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Japanese subjects with type 2 diabetes mellitus and a clinical diagnosis of DN (Diabetic Nephropathy) treated with at least the minimal recommended dose of an Angiotensin Converting Enzyme Inhibitor (ACEI) and/or Angiotensin Receptor Blocker (ARB)
Subjects with a clinical diagnosis of Diabetic Nephropathy (DN) based on at least 1 of the following criteria:
- Persistent very high albuminuria defined as Urinary Albumin to Creatine Ratio (UACR) of >/=300 mg/g (>/=34 mg/mmol) in 2 out of 3 first morning void samples and estimated glomerular filtration rate (eGFR) >/=30 mL/min/1.73 m2 but <90 mL/min/1.73 m2 Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) or
- Persistent high albuminuria defined as UACR of >/=30 mg/g but <300 mg/g (>/=3.4 mg/mmol but <34 mg/mmol) in 2 out of 3 first morning void samples and eGFR>/=30 mL/min/1.73 m2 but <90 mL/min/1.73 m2 (CKD-EPI)
Serum potassium </=4.8 mmol/L at both the run-in visit and the screening visit

Exclusion Criteria:

Non-diabetic renal disease (confirmed by biopsy)
Known bilateral clinically relevant renal artery stenosis (>75%)
Glycated hemoglobin(HbA1c) >12% at the run-in visit or the screening visit
UACR >3000 mg/g (339 mg/mmol) in any of the urinary first morning void samples at the run-in visit or screening visit
Hypertension with mean sitting systolic blood pressure (SBP) >/=180 mmHg or mean sitting diastolic blood pressure (DBP) >/=110 mmHg at the run-in visit or mean sitting SBP >/=160 mmHg or mean sitting DBP >/=100 mmHg at the screening visit
Subjects with a clinical diagnosis of heart failure with reduced ejection fraction (HFrEF) and persistent symptoms (New York Heart Association class II-IV) at the run-in visit
Concomitant therapy with eplerenone, spironolactone, any renin inhibitor, or potassium-sparing diuretic

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

BAY94-8862 (1.25 mg)

BAY94-8862 (2.5 mg)

BAY94-8862 (5 mg )

BAY94-8862 (7.5 mg)

BAY94-8862 (10 mg)

Placebo

BAY 94-8862 (15 mg)

BAY 94-8862 (20 mg)

Arm Description

Outcomes

Primary Outcome Measures

Change of urinary albumin-to creatinine ratio

Secondary Outcome Measures

Change in serum potassium concentration

Full Information

NCT ID

NCT01968668

First Posted

October 21, 2013

Last Updated

July 15, 2021

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT01968668

Brief Title

Safety and Efficacy of Different Oral Doses of BAY94-8862 in Japanese Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy (ARTS-DN Japan)

Official Title

A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Safety and Efficacy of Different Oral Doses of BAY94-8862 in Japanese Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

October 28, 2013 (Actual)

Primary Completion Date

October 9, 2014 (Actual)

Study Completion Date

November 7, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study will be conducted in Japanese subjects with type 2 diabetes mellitus and the clinical diagnosis of Diabetic Nephropathy( DN) using a multi-center, randomized, adaptive, double-blind, placebo-controlled, parallel-group design. Primary objective of the study is investigate the change of Urinary Albumin to Creatine Ratio (UACR) after treatment with different oral doses of BAY94-8862 given once daily from baseline to Visit 8 (Day 90)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Nephropathies

Keywords

BAY94-8862, MR antagonist, Diabetic nephropathy, Japanese patients

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

96 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BAY94-8862 (1.25 mg)

Arm Type

Experimental

Arm Title

BAY94-8862 (2.5 mg)

Arm Type

Experimental

Arm Title

BAY94-8862 (5 mg )

Arm Type

Experimental

Arm Title

BAY94-8862 (7.5 mg)

Arm Type

Experimental

Arm Title

BAY94-8862 (10 mg)

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

BAY 94-8862 (15 mg)

Arm Type

Experimental

Arm Title

BAY 94-8862 (20 mg)

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

BAY94-8862

Intervention Description

1.25 mg BAY94-8862 tablet once daily in the morning

Intervention Type

Drug

Intervention Name(s)

BAY94-8862

Intervention Description

2.5 mg BAY94-8862 tablet once daily in the morning

Intervention Type

Drug

Intervention Name(s)

BAY94-8862

Intervention Description

5 mg BAY94-8862 tablet once daily in the morning

Intervention Type

Drug

Intervention Name(s)

BAY94-8862

Intervention Description

7.5 mg BAY94-8862 tablet once daily in the morning

Intervention Type

Drug

Intervention Name(s)

BAY94-8862

Intervention Description

10 mg BAY94-8862 tablet once daily in the morning

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo tablet once daily in the morning

Intervention Type

Drug

Intervention Name(s)

BAY 94-8862

Intervention Description

15 mg BAY 94-8862 tablet once daily in the morning

Intervention Type

Drug

Intervention Name(s)

BAY 94-8862

Intervention Description

20 mg BAY 94-8862 tablet once daily in the morning

Primary Outcome Measure Information:

Title

Change of urinary albumin-to creatinine ratio

Time Frame

Baseline and 90 days

Secondary Outcome Measure Information:

Title

Change in serum potassium concentration

Time Frame

Baseline and 90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Japanese subjects with type 2 diabetes mellitus and a clinical diagnosis of DN (Diabetic Nephropathy) treated with at least the minimal recommended dose of an Angiotensin Converting Enzyme Inhibitor (ACEI) and/or Angiotensin Receptor Blocker (ARB) Subjects with a clinical diagnosis of Diabetic Nephropathy (DN) based on at least 1 of the following criteria: Persistent very high albuminuria defined as Urinary Albumin to Creatine Ratio (UACR) of >/=300 mg/g (>/=34 mg/mmol) in 2 out of 3 first morning void samples and estimated glomerular filtration rate (eGFR) >/=30 mL/min/1.73 m2 but <90 mL/min/1.73 m2 Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) or Persistent high albuminuria defined as UACR of >/=30 mg/g but <300 mg/g (>/=3.4 mg/mmol but <34 mg/mmol) in 2 out of 3 first morning void samples and eGFR>/=30 mL/min/1.73 m2 but <90 mL/min/1.73 m2 (CKD-EPI) Serum potassium </=4.8 mmol/L at both the run-in visit and the screening visit Exclusion Criteria: Non-diabetic renal disease (confirmed by biopsy) Known bilateral clinically relevant renal artery stenosis (>75%) Glycated hemoglobin(HbA1c) >12% at the run-in visit or the screening visit UACR >3000 mg/g (339 mg/mmol) in any of the urinary first morning void samples at the run-in visit or screening visit Hypertension with mean sitting systolic blood pressure (SBP) >/=180 mmHg or mean sitting diastolic blood pressure (DBP) >/=110 mmHg at the run-in visit or mean sitting SBP >/=160 mmHg or mean sitting DBP >/=100 mmHg at the screening visit Subjects with a clinical diagnosis of heart failure with reduced ejection fraction (HFrEF) and persistent symptoms (New York Heart Association class II-IV) at the run-in visit Concomitant therapy with eplerenone, spironolactone, any renin inhibitor, or potassium-sparing diuretic

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

456-0058

Country

Japan

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

466-0815

Country

Japan

City

Saijo

State/Province

Ehime

ZIP/Postal Code

793-0027

Country

Japan

City

Kurume

State/Province

Fukuoka

ZIP/Postal Code

830-8522

Country

Japan

City

Kurume

State/Province

Fukuoka

ZIP/Postal Code

830-8543

Country

Japan

City

Obihiro

State/Province

Hokkaido

ZIP/Postal Code

080-0848

Country

Japan

City

Amagasaki

State/Province

Hyogo

ZIP/Postal Code

660-8550

Country

Japan

City

Koga

State/Province

Ibaraki

ZIP/Postal Code

306-0232

Country

Japan

City

Tsuchiura

State/Province

Ibaraki

ZIP/Postal Code

300-0835

Country

Japan

City

Tsukuba

State/Province

Ibaraki

ZIP/Postal Code

305-0812

Country

Japan

City

Kahoku-gun

State/Province

Ishikawa

ZIP/Postal Code

920-0293

Country

Japan

City

Sakaide

State/Province

Kagawa

ZIP/Postal Code

762-0007

Country

Japan

City

Izumisano

State/Province

Osaka

ZIP/Postal Code

598-8577

Country

Japan

City

Yao

State/Province

Osaka

ZIP/Postal Code

581-0011

Country

Japan

City

Katsushika

State/Province

Tokyo

ZIP/Postal Code

125-0054

Country

Japan

City

Osaka

ZIP/Postal Code

530-0001

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

31583611

Citation

Snelder N, Heinig R, Drenth HJ, Joseph A, Kolkhof P, Lippert J, Garmann D, Ploeger B, Eissing T. Population Pharmacokinetic and Exposure-Response Analysis of Finerenone: Insights Based on Phase IIb Data and Simulations to Support Dose Selection for Pivotal Trials in Type 2 Diabetes with Chronic Kidney Disease. Clin Pharmacokinet. 2020 Mar;59(3):359-370. doi: 10.1007/s40262-019-00820-x.

Results Reference

derived

Links:

URL

http://clinicaltrials.bayer.com/

Description

Click here to find results for studies related to Bayer Healthcare products.

Learn more about this trial

Safety and Efficacy of Different Oral Doses of BAY94-8862 in Japanese Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy (ARTS-DN Japan)

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