Diabetic Kidney DiseasePhase 2CADA DIANCT03412006
A Double-blind Study to Investigate Efficacy, Safety and Tolerability of BAY1142524 in Patients With Type II Diabetes and a Clinical Diagnosis of Diabetic Kidney Disease
A Phase 2 study testing Fulacimstat (BAY1142524) in people with Diabetic Kidney Disease, run by Bayer at 27 sites in 7 countries.
Trial summary
The purpose of the trial is the analysis of safety and efficacy of the chymase inhibitor BAY1142524 at a dose of 25 mg BID in comparison to placebo using a 6 months treatment period in type II diabetic patients with a clinical diagnosis of diabetic kidney disease. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Diabetic Kidney Disease
- What is being tested?
- Fulacimstat (BAY1142524)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 27 sitesin 7 countries
- Study dates
- 2 Feb 2018to 10 Oct 2019
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Type 2 Diabetes Mellitus and a clinical diagnosis of diabetic kidney disease (DKD) (as judged by the investigator) who have finished their up-titration with an angiotensin receptor blocker (ARB) or an ACEI (angiotensin-converting enzyme inhibitor) to their maximum tolerated dose at least 3 months prior to the screening visit, whereby the maximum tolerated dose has to be at least as high as the minimal recommended dose of an ARB or ACEI according to local and/or international guidelines. Patients have to be treated with an ARB or ACEI, but not with both simultaneously, without any adjustments to this therapy for at least 4 weeks prior to the screening visit.
- UACR >50 mg/g and <3000 mg/g in 2 out of 3 consecutive morning void samples at the screening and the baseline visit
- estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m*2 and <90 mL/min/1.73 m*2 (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) at the screening visit and the baseline visit
Who cannot join
- Non-DKD if it is the main diagnosis contributory to chronic kidney disease (CKD), as judged by the investigator
- Known bilateral clinical relevant renal artery stenosis (>75%)
- New York Heart Association (NYHA) Class IV
- Acute kidney injury or dialysis within the last 3 months before the screening visit
- Renal replacement therapy during study conduct
- Renal allograft in place or a scheduled kidney transplant during study conduct
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- Stroke, transient ischemic cerebral attack, acute coronary syndrome, or hospitalization for heart failure in the last 3 months prior to screening visit
- Clinically relevant hepatic dysfunction
- Uncontrolled hypertension as evidenced by systolic blood pressure >160 mmHg, diastolic blood pressure >100 mmHg (mean of triplicate values at the screening or baseline visit)
Trial locations and contacts
27 sites in 7 countries.
27 sites in 7 countries
Israel6 sites
Barzilai Medical Center
Ashkelon, 7830604
Edith Wolfson Medical Center
Holon, 5822012
Hadassah Hebrew University Hospital Ein Kerem
Jerusalem, 9112001
The Nazareth Trust Hospital EMMS
Nazareth, 16100
DMC - Diabetes Medical Center
Tel Aviv, 6937947
Shamir Medical Center (Assaf Harofeh)
Tsrifin, 7030000
Finland4 sites
Pihlajalinna ITE Kuopio
Kuopio, 70100
Terveystalo Oulu
Oulu, FI-90100
TAYS TKI Keskus Tutkimusvastaanotto
Tampere, 33520
Turun yliopistollinen keskussairaala, kantasairaala
Turku, FIN-20520
Italy4 sites
Univ. Alma Mater - Dip. Medicina Spec, Diagnostica e Sperim
Bologna, Emilia-Romagna, 40138
IRCCS Casa Sollievo della Sofferenza
Foggia, Apulia, 71013
A.O.U. Policlinico Federico II Napoli
Naples, Campania, 80131
A.O.U. di Padova
Padova, Veneto, 35128
Sweden4 sites
Centralsjukhuset Kristianstad
Kristianstad, 29185
Universitetssjukhuset Örebro
Örebro, 701 85
Akardo MedSite AB
Stockholm, 114 46
S3 Clinical Research Centers
Vällingby, 162 68
Bulgaria3 sites
Med Centre Diamedical 2013
Dimitrovgrad, 6400
MCOMH Preventsia-2000
Stara Zagora, 6000
Med. Center Equita
Varna, 9000
Denmark3 sites
Rigshospitalet
Copenhagen, 2100
Steno Diabetes Center Copenhagen
Gentofte Municipality, 2730
Nordsjællands Hospital
Hillerød, 3400
Spain3 sites
Hospital Fundació Puigvert
Barcelona, 08025
Complexo Hospitalario Universitario de Ferrol
Ferrol, A Coruña, 15405
Hospital de Galdakao
Galdakao, Vizcaya, 48960
About this study
Official title: A Randomized, Double-blind, Multicenter Study to Assess the Efficacy and Safety of a 6 Month Oral Treatment With the Chymase Inhibitor BAY 1142524 at a Dose of 25 mg BID in Comparison to Placebo on Top of Standard of Care in Patients With Type II Diabetes and a Clinical Diagnosis of Diabetic Kidney Disease
The purpose of the trial is the analysis of safety and efficacy of the chymase inhibitor BAY1142524 at a dose of 25 mg BID in comparison to placebo using a 6 months treatment period in type II diabetic patients with a clinical diagnosis of diabetic kidney disease. BAY1142524 or placebo will be given on top of evidence-based standard of care for diabetic kidney disease. Primary objective is the analysis of first signs of efficacy as determined by favourable changes in urinary albumin creatinine ratio. Secondary objective is the analysis of safety and tolerability as evidenced by the incidence and severity of adverse events. 64 valid patients have to complete treatment with verum and 32 valid patients have to complete treatment with placebo.
- Conditions
- Diabetic Kidney Disease
- Being tested
- Fulacimstat (BAY1142524), Placebo
- Keywords
- type II diabetes, diabetic kidney disease
- Medical subject headings
- Diabetic Nephropathies, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fulacimstat (BAY1142524)Drug
25 mg BAY1142524 are given twice daily over a treatment period of 6 months
PlaceboDrug
Matching placebo tablets are given twice daily over a treatment period of 6 months
| Study group | Role | What they receive |
|---|---|---|
| Fulacimstat (BAY1142524) | Experimental | Patients have to have a clinical diagnosis of diabetic kidney disease and have to be treated with standard of care for this condition Receives: Drug: Fulacimstat (BAY1142524) |
| Placebo | Placebo comparator | Patients have to have a clinical diagnosis of diabetic kidney disease and have to be treated with standard of care for this condition Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urinary albumin to creatinine ratio (UACR)
The ratio of albumin to creatinin will be determined in first morning void urine at baseline (before treatment start) and after 6 months of treatment
Measured: Baseline and at 6 months
Secondary outcomes (2)
Number of patients with treatment-emergent adverse event
Measured: From first intake of study drug up to 3 days after last administration of study drug
Number of patients with serious adverse events
Measured: From first intake of study drug up to 3 days after last administration of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start2 Feb 2018
- Primary completion2 Oct 2019
- Study completion10 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Kidney DiseaseStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03412006
- Sponsor's protocol ID
- 18933
- Other IDs
- 2017-000656-26, 2017
- Acronym
- CADA DIA
- Status last verified
- Feb 2022
- First submitted
- 22 Jan 2018
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multicenter Study to Assess the Efficacy and Safety of a 6 Month Oral Treatment With the Chymase Inhibitor BAY 1142524 at a Dose of 25 mg BID in Comparison to Placebo on Top of Standard of Care in Patients With Type II Diabetes and a Clinical Diagnosis of Diabetic Kidney Disease
- ClinicalTrials.gov ID
- NCT03412006
- Acronym / sponsor ID
- CADA DIA / 18933
- Conditions
- Diabetic Kidney Disease
- Keywords
- type II diabetes, diabetic kidney disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2018 (actual)
- Primary completion
- 2 Oct 2019 (actual)
- Study completion
- 10 Oct 2019 (actual)
- First posted
- 26 Jan 2018 (actual)
- 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.
The purpose of the trial is the analysis of safety and efficacy of the chymase inhibitor BAY1142524 at a dose of 25 mg BID in comparison to placebo using a 6 months treatment period in type II diabetic patients with a clinical diagnosis of diabetic kidney disease. BAY1142524 or placebo will be given on top of evidence-based standard of care for diabetic kidney disease. Primary objective is the analysis of first signs of efficacy as determined by favourable changes in urinary albumin creatinine ratio. Secondary objective is the analysis of safety and tolerability as evidenced by the incidence and severity of adverse events. 64 valid patients have to complete treatment with verum and 32 valid patients have to complete treatment with placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fulacimstat (BAY1142524) | Experimental | Drug: Fulacimstat (BAY1142524)Patients have to have a clinical diagnosis of diabetic kidney disease and have to be treated with standard of care for this condition |
| Placebo | Placebo comparator | Drug: PlaceboPatients have to have a clinical diagnosis of diabetic kidney disease and have to be treated with standard of care for this condition |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with Type 2 Diabetes Mellitus and a clinical diagnosis of diabetic kidney disease (DKD) (as judged by the investigator) who have finished their up-titration with an angiotensin receptor blocker (ARB) or an ACEI (angiotensin-converting enzyme inhibitor) to their maximum tolerated dose at least 3 months prior to the screening visit, whereby the maximum tolerated dose has to be at least as high as the minimal recommended dose of an ARB or ACEI according to local and/or international guidelines. Patients have to be treated with an ARB or ACEI, but not with both simultaneously, without any adjustments to this therapy for at least 4 weeks prior to the screening visit.
- UACR >50 mg/g and <3000 mg/g in 2 out of 3 consecutive morning void samples at the screening and the baseline visit
- estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m*2 and <90 mL/min/1.73 m*2 (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) at the screening visit and the baseline visit
Key exclusion criteria (9 listed)
- Non-DKD if it is the main diagnosis contributory to chronic kidney disease (CKD), as judged by the investigator
- Known bilateral clinical relevant renal artery stenosis (>75%)
- New York Heart Association (NYHA) Class IV
- Acute kidney injury or dialysis within the last 3 months before the screening visit
- Renal replacement therapy during study conduct
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 |
|---|---|---|
| Fulacimstat (BAY1142524)25 mg BAY1142524 are given twice daily over a treatment period of 6 months | Drug | Fulacimstat (BAY1142524) |
| PlaceboMatching placebo tablets are given twice daily over a treatment period of 6 months | Drug | Placebo |
Primary outcome
Change in urinary albumin to creatinine ratio (UACR)
Time frame: Baseline and at 6 months
The ratio of albumin to creatinin will be determined in first morning void urine at baseline (before treatment start) and after 6 months of treatment
2 secondary outcomes
Number of patients with treatment-emergent adverse event
Time frame: From first intake of study drug up to 3 days after last administration of study drug
Number of patients with serious adverse events
Time frame: From first intake of study drug up to 3 days after last administration of study drug
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 3 Mar 2022.
- Click here to find information about studies related to Bayer Healthcare products conducted in Europe.Link provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
27 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fulacimstat (BAY1142524) in people with Diabetic Kidney Disease, run by Bayer at 27 sites in 7 countries.
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 3 inclusion and 9 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 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Israel, Finland, Italy, Sweden, Bulgaria and 2 more countries. 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 in urinary albumin to creatinine ratio (UACR) (time frame: Baseline and at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2022.