Status:
COMPLETED
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
Lead Sponsor:
Bayer
Conditions:
Diabetic Kidney Disease
Eligibility:
All Genders
18-79 years
Phase:
PHASE2
Brief 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 diabeti...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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)
Key Trial Info
Start Date :
February 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2019
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT03412006
Start Date
February 2 2018
End Date
October 10 2019
Last Update
March 3 2022
Active Locations (27)
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1
Med Centre Diamedical 2013
Dimitrovgrad, Bulgaria, 6400
2
MCOMH Preventsia-2000
Stara Zagora, Bulgaria, 6000
3
Med. Center Equita
Varna, Bulgaria, 9000
4
Rigshospitalet
Copenhagen, Denmark, 2100