A Trial to Learn More About How BAY2327949 Works and How Safe it is in Patients Whose Kidneys Are Damaged Due to High Blood Sugar Levels or High Blood Pressures, and With a Further Disease of the Heart or the Blood Vessels.

Chronic Kidney Disease Clinical Trial

— ASSESS-CKD  

Official title:

A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Efficacy and Safety of BAY 2327949 in Patients With Chronic Kidney Disease (eGFR Range From 25 to 60 mL/Min/1.73 m²) Due to Type 2 Diabetes or Hypertension and at Least One Cardiovascular Comorbidity

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04661917
• Other study ID #: 19225
• Secondary ID: 2020-002192-35
• Status: Withdrawn
• Phase: Phase 2
• Start date: May 31, 2021
• Est. completion date: May 19, 2022

Study information

• Verified date: May 2021
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In people with type 2 diabetes (T2D), the body makes insulin, but cannot use it well. This results in high blood sugar levels causing damage to the blood vessels inside the kidneys.

High blood pressure is a common condition that can cause damage to the blood vessels and heart if it is untreated. High blood pressure is also known as hypertension.

Patients with type 2 diabetes (T2D) or high blood pressure are at a higher risk of having chronic kidney disease (CKD). In people with CKD, the kidneys become damaged and do not work as they should. Over time, the function of the kidney declines more, and this can lead to the requirement for dialysis or kidney transplantation. Most people with CKD are also at risk of heart conditions, such as heart attack or stroke.

In this trial, the researchers want to learn if BAY2327949 reduces the amount of protein in the participants' urine. Protein in the urine is one of the signs of CKD. The researchers will compare the effects of BAY2327949 to a placebo. A placebo looks like the study drug but does not have any medicine in it. BAY2327949 is assumed to increase the blood flow through the kidneys, which may slow down the worsening of the disease. The researchers will use a placebo to learn if the changes seen in the participants are due to BAY2327949 or if the results could be due to chance.

This trial will include about 120 men and women over the age of 45 who have CKD. The participants will have T2D or high blood pressure, and a further disease of the heart or blood vessels.

During the trial, the participants will take either BAY2327949 or a placebo once a day for 28 days. The participants will visit their trial site about 9 times during the trial, and need to provide urine samples to check the participants' CKD symptoms. At the visits, the doctors will ask them if they have any health problems. They will also take blood samples to perform laboratory assessments.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 19, 2022
• Est. primary completion date: April 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• A clinical diagnosis of chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) = 25 mL/min/1.73 m^2 but = 60 mL/min/1.73 m^2 (estimated using the CKD-EPI [Epidemiology Collaboration] equation) as assessed during Visit 1, and albuminuria (as measured by urine albumin-to-creatinine ratio [UACR]) in the range of = 30 but = 3000 mg/g, based on the first assessment for Visit 1.

• CKD with a clinical cause of either T2D or hypertension: -- if T2D is the clinical cause, history of type 2 diabetes mellitus as defined by the American Diabetes Association (on treatment with glucose-lowering medications and/or insulin) for at least 2 years before randomization and on a stable therapy with sodium-glucose transport protein 2 (SGLT2) inhibitor for at least 3 months before randomization; -- if hypertension is the clinical cause, patients must have a history of systolic blood pressure (BP) values = 140 mmHg and/or diastolic BP values = 90 mmHg, and on hypertension medication for at least 5 years before randomization.

• Stable treatment with either angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) at the maximal tolerated labelled daily dose and otherwise stable antihypertensive treatment both for at least 3 months before randomization. If taking an SGLT2 inhibitor, the participant must be on stable treatment for at least 3 months before randomization without any planned changes in dosing during the study period. All treatments must be expected to remain stable over the study period without any planned dose adjustments.

• Body mass index within the range of 18-38 kg/m^2 as evaluated for Visit 1.

• Male participants must agree to use barrier contraception (condoms). Female participants must be of non-child-bearing potential.

Exclusion Criteria:

• Known non-diabetic or non-hypertensive renal disease (e.g. autosomal dominant polycystic kidney disease or autosomal recessive polycystic kidney disease, bilateral clinically relevant renal artery stenosis, lupus nephritis, or ANCA-associated vasculitis, or any other secondary glomerulonephritis).

• Clinical diagnoses of heart failure and persistent symptoms (NYHA [New York Heart Association] class III - IV), or hospitalization for worsening heart failure in the last 3 months prior to signing the informed consent form (ICF).

• Uncontrolled hypertension indicated by >160 mmHg systolic BP or =100 mmHg diastolic BP at Visit 1 or Visit 2 or at any unscheduled visit before randomization.

• History of secondary hypertension (i.e., renal artery stenosis, primary aldosteronism, or pheochromocytoma); stroke, transient ischemic cerebral attack, acute coronary syndrome in the last 3 months prior to signing the ICF.

• Dialysis for acute renal failure within the previous 6 months prior to signing the ICF.

• Renal allograft in place or a scheduled kidney transplant within the next 18 weeks from signing the ICF (being on a waiting list does not exclude the participant).

• Hepatic insufficiency classified as Child-Pugh B or C or other significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis as indicated by e.g. AST/ALT >3x ULN).

• Active malignancy. Previous malignancies are allowed if there is a 5-year remission- and treatment-free time before signing the ICF.

• Any surgical or medical condition, which in the opinion of the investigator, may place the participant at higher risk from his/her participation in the study, or is likely to prevent the participant from complying with the requirements of the study or completing the study.

• For participants without diabetes: receiving off-label treatment with an SGLT2 inhibitor.

• Indication for immunosuppressants, receiving cytotoxic therapy, immunosuppressive therapy, or other immunotherapy within 6 months prior to signing ICF.

• Combination use of an ACE inhibitor and ARB within 3 months prior to signing ICF.

• Concomitant therapy with drugs that strongly induce or inhibit CYP3A4 (cytochrome P-450 3A4), or that are inhibitors of P-gp (P-glucoprotein).

• Planned change of concomitant medications or dose adjustments during participation in this study.

• Participation in another clinical study with treatment with another investigational product 90 days prior to signing ICF.

• HbA1c > 11% at Visit 1.

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Diabetic Kidney Disease
• Diabetic Nephropathies
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• BAY2327949
60 mg of BAY2327949 (2 tablets of 30 mg, orally) once daily for 28 days.
• Placebo
Matching placebo orally once daily for 28 days.

Locations

Country	Name	City	State
Austria	Landeskrankenhaus Feldkirch	Feldkirch	Vorarlberg
Austria	Medizinische Universität Graz	Graz	Steiermark
Austria	Konventhospital Barmherzige Brüder Linz	Linz	Oberösterreich
Austria	Universitätsklinikum St. Pölten	St. Pölten
Austria	Klinik Hietzing	Wien
Austria	Universitätsklinikum AKH Wien	Wien
Austria	Zentrum f. klinische Studien Dr. Hanusch GmbH	Wien
Denmark	Aarhus Universitetshospital, Skejby	Aarhus N
Denmark	Sydvestjysk Sygehus Esbjerg	Esbjerg
Denmark	Regionshospitalet Herning	Herning
Denmark	Nordsjællands Hospital	Hillerød
Denmark	Hvidovre Hospital	Hvidovre
Denmark	Odense Universitetshospital	Odense C
Finland	Health Step Finland Oy	Kuopio
Finland	Päijät-Hämeen keskussairaala	Lahti
Finland	Oulun yliopistollinen sairaala	Oulu
Finland	Seinäjoen keskussairaala	Seinäjoki
Finland	Turun yliopistollinen keskussairaala, kantasairaala	Turku
Netherlands	Academisch Medisch Centrum (AMC)	Amsterdam
Netherlands	Albert Schweitzer Ziekenhuis, Locatie Dordwijk	Dordrecht
Netherlands	Maxima Medisch Centrum, locatie Eindhoven	Eindhoven
Netherlands	Albert Schweitzer Ziekenhuis, locatie Zwijndrecht	Zwijndrecht
Norway	AKTIMED Helse AS	Hamar
Norway	Sykehuset Innlandet HF Hamar	Hamar
Norway	Oslo Universitetssykehus HF, Rikshospitalet	Oslo
Norway	Skedsmo Medisinske Senter	Skedsmokorset
Norway	Stavanger Helseforskning AS	Stavanger
Norway	St. Olavs Hospital HF	Trondheim
Sweden	Carlanderska Sjukhuset	Göteborg
Sweden	ProbarE	Lund
Sweden	Dalecarlia Clinical Research	Rättvik
Sweden	Center For Diabetes, Academic Specialist Center	Stockholm
Sweden	Akademiska Sjukhuset	Uppsala
Switzerland	Inselspital Universitätsspital Bern	Bern
Switzerland	Centre Hospitalier Universitaire Vaudois (CHUV)	Lausanne	Vaud
Switzerland	Kantonsspital St. Gallen	St. Gallen	Sankt Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Austria,  Denmark,  Finland,  Netherlands,  Norway,  Sweden,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in urine albumin-to-creatinine ratio (UACR) to the end of treatment (Visit 6)		Baseline and Visit 6 (28 days)
Secondary	Frequency of treatment-emergent adverse events (TEAEs)		From the first treatment with the study intervention until 7 days after the last dose, up to 5 weeks