NCT01968668

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 24, 2013

Completed
4 days until next milestone

Study Start

First participant enrolled

October 28, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2014

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2014

Completed
Last Updated

July 16, 2021

Status Verified

July 1, 2021

Enrollment Period

12 months

First QC Date

October 21, 2013

Last Update Submit

July 15, 2021

Conditions

Diabetic Nephropathies

Keywords

BAY94-8862MR antagonistDiabetic nephropathyJapanese patients

Outcome Measures

Primary Outcomes (1)

  • Change of urinary albumin-to creatinine ratio

    Baseline and 90 days

Secondary Outcomes (1)

  • Change in serum potassium concentration

    Baseline and 90 days

Study Arms (8)

BAY94-8862 (1.25 mg)

EXPERIMENTAL
Drug: BAY94-8862

BAY94-8862 (2.5 mg)

EXPERIMENTAL
Drug: BAY94-8862

BAY94-8862 (5 mg )

EXPERIMENTAL
Drug: BAY94-8862

BAY94-8862 (7.5 mg)

EXPERIMENTAL
Drug: BAY94-8862

BAY94-8862 (10 mg)

EXPERIMENTAL
Drug: BAY94-8862

Placebo

PLACEBO COMPARATOR
Drug: Placebo

BAY 94-8862 (15 mg)

EXPERIMENTAL
Drug: BAY 94-8862

BAY 94-8862 (20 mg)

EXPERIMENTAL
Drug: BAY 94-8862

Interventions

BAY94-8862DRUG

1.25 mg BAY94-8862 tablet once daily in the morning

BAY94-8862 (1.25 mg)
PlaceboDRUG

Placebo tablet once daily in the morning

Placebo
BAY 94-8862DRUG

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

BAY 94-8862 (15 mg)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Unknown Facility

Nagoya, Aichi-ken, 456-0058, Japan

Location

Unknown Facility

Nagoya, Aichi-ken, 466-0815, Japan

Location

Unknown Facility

Saijō, Ehime, 793-0027, Japan

Location

Unknown Facility

Kurume, Fukuoka, 830-8522, Japan

Location

Unknown Facility

Kurume, Fukuoka, 830-8543, Japan

Location

Unknown Facility

Obihiro, Hokkaido, 080-0848, Japan

Location

Unknown Facility

Amagasaki, Hyōgo, 660-8550, Japan

Location

Unknown Facility

Koga, Ibaraki, 306-0232, Japan

Location

Unknown Facility

Tsuchiura, Ibaraki, 300-0835, Japan

Location

Unknown Facility

Tsukuba, Ibaraki, 305-0812, Japan

Location

Unknown Facility

Kahoku-gun, Ishikawa-ken, 920-0293, Japan

Location

Unknown Facility

Sakaidechō, Kagawa-ken, 762-0007, Japan

Location

Unknown Facility

Izumisano, Osaka, 598-8577, Japan

Location

Unknown Facility

Yao, Osaka, 581-0011, Japan

Location

Unknown Facility

Katsushika-ku, Tokyo, 125-0054, Japan

Location

Unknown Facility

Osaka, 530-0001, Japan

Location

Related Publications (1)

  • 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.

    PMID: 31583611DERIVED

Related Links

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

finerenone

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2013

First Posted

October 24, 2013

Study Start

October 28, 2013

Primary Completion

October 9, 2014

Study Completion

November 7, 2014

Last Updated

July 16, 2021

Record last verified: 2021-07

Locations

JP(16)