Diabetic NephropathiesPhase 2NCT01968668
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)
A Phase 2 study testing BAY94-8862 and BAY 94-8862 in people with Diabetic Nephropathies, run by Bayer at 16 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Nephropathies
- What is being tested?
- BAY94-8862 and BAY 94-8862
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 16 sitesJapan
- Study dates
- 28 Oct 2013to 7 Nov 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Japan16 sites
Study site
Amagasaki, Hyōgo, 660-8550
Study site
Izumisano, Osaka, 598-8577
Study site
Kahoku-gun, Ishikawa-ken, 920-0293
Study site
Katsushika-ku, Tokyo, 125-0054
Study site
Koga, Ibaraki, 306-0232
Study site
Kurume, Fukuoka, 830-8522
Study site
Kurume, Fukuoka, 830-8543
Study site
Nagoya, Aichi-ken, 456-0058
Study site
Nagoya, Aichi-ken, 466-0815
Study site
Obihiro, Hokkaido, 080-0848
Study site
Osaka, 530-0001
Study site
Saijō, Ehime, 793-0027
Study site
Sakaidechō, Kagawa-ken, 762-0007
Study site
Tsuchiura, Ibaraki, 300-0835
Study site
Tsukuba, Ibaraki, 305-0812
Study site
Yao, Osaka, 581-0011
About this study
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
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)
- Conditions
- Diabetic Nephropathies
- Being tested
- BAY94-8862, Placebo, BAY 94-8862
- Keywords
- BAY94-8862, MR antagonist, Diabetic nephropathy, Japanese patients
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY94-8862Drug
1.25 mg BAY94-8862 tablet once daily in the morning
BAY94-8862Drug
2.5 mg BAY94-8862 tablet once daily in the morning
BAY94-8862Drug
5 mg BAY94-8862 tablet once daily in the morning
BAY94-8862Drug
7.5 mg BAY94-8862 tablet once daily in the morning
BAY94-8862Drug
10 mg BAY94-8862 tablet once daily in the morning
PlaceboDrug
Placebo tablet once daily in the morning
BAY 94-8862Drug
15 mg BAY 94-8862 tablet once daily in the morning
BAY 94-8862Drug
20 mg BAY 94-8862 tablet once daily in the morning
| Study group | Role | What they receive |
|---|---|---|
| BAY94-8862 (1.25 mg) | Experimental | Not described Receives: Drug: BAY94-8862 |
| BAY94-8862 (2.5 mg) | Experimental | Not described Receives: Drug: BAY94-8862 |
| BAY94-8862 (5 mg ) | Experimental | Not described Receives: Drug: BAY94-8862 |
| BAY94-8862 (7.5 mg) | Experimental | Not described Receives: Drug: BAY94-8862 |
| BAY94-8862 (10 mg) | Experimental | Not described Receives: Drug: BAY94-8862 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| BAY 94-8862 (15 mg) | Experimental | Not described Receives: Drug: BAY 94-8862 |
| BAY 94-8862 (20 mg) | Experimental | Not described Receives: Drug: BAY 94-8862 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of urinary albumin-to creatinine ratio
Measured: Baseline and 90 days
Secondary outcomes (1)
Change in serum potassium concentration
Measured: Baseline and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2013 (estimated)
- Study start28 Oct 2013
- Primary completion9 Oct 2014
- Study completion7 Nov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic NephropathiesStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01968668
- Sponsor's protocol ID
- 16816
- Status last verified
- Jul 2021
- First submitted
- 21 Oct 2013
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Li P, Cui Y, Xu X, Dong J, Liao L. Cardiorenal Benefits of Finerenone in Different Races and Kidney Function in Patients with Chronic Kidney Disease. Cardiorenal Med. 2024;14(1):227-234. doi: 10.1159/000538347. Epub 2024 Mar 27.
PubMed 38537621Snelder 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.
PubMed 31583611
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01968668
- Acronym / sponsor ID
- 16816
- Conditions
- Diabetic Nephropathies
- Keywords
- BAY94-8862, MR antagonist, Diabetic nephropathy, Japanese patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2013 (actual)
- Primary completion
- 9 Oct 2014 (actual)
- Study completion
- 7 Nov 2014 (actual)
- First posted
- 24 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
- Serum potassium </=4.8 mmol/L at both the run-in visit and the screening visit
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAY94-88621.25 mg BAY94-8862 tablet once daily in the morning | Drug | BAY94-8862 (1.25 mg) |
| BAY94-88622.5 mg BAY94-8862 tablet once daily in the morning | Drug | BAY94-8862 (2.5 mg) |
| BAY94-88625 mg BAY94-8862 tablet once daily in the morning | Drug | BAY94-8862 (5 mg ) |
| BAY94-88627.5 mg BAY94-8862 tablet once daily in the morning | Drug | BAY94-8862 (7.5 mg) |
| BAY94-886210 mg BAY94-8862 tablet once daily in the morning | Drug | BAY94-8862 (10 mg) |
| PlaceboPlacebo tablet once daily in the morning | Drug | Placebo |
| BAY 94-886215 mg BAY 94-8862 tablet once daily in the morning | Drug | BAY 94-8862 (15 mg) |
| BAY 94-886220 mg BAY 94-8862 tablet once daily in the morning | Drug | BAY 94-8862 (20 mg) |
Primary outcome
Change of urinary albumin-to creatinine ratio
Time frame: Baseline and 90 days
1 secondary outcome
Change in serum potassium concentration
Time frame: Baseline and 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
- Derived from this study: PubMed 38537621Li P, Cui Y, Xu X, Dong J, Liao L. Cardiorenal Benefits of Finerenone in Different Races and Kidney Function in Patients with Chronic Kidney Disease. Cardiorenal Med. 2024;14(1):227-234. doi: 10.1159/000538347. Epub 2024 Mar 27.
- Derived from this study: PubMed 31583611Snelder 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BAY94-8862 and BAY 94-8862 in people with Diabetic Nephropathies, run by Bayer at 16 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of urinary albumin-to creatinine ratio (time frame: Baseline and 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01968668, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2021.