stop_circleTerminated/Withdrawn
Chronic Kidney Disease, Diabetic Kidney Disease
Bayer Identifier:
19225
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
Trial purpose
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.
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.
Key Participants Requirements
Sex
AllAge
45 - N/ATrial summary
Enrollment Goal
0Trial Dates
May 2021 - May 2022Phase
Phase 2Could I Receive a placebo
YesProducts
BAY2327949Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Withdrawn | Öbackakliniken | Härnösand, 871 31, Sweden |
Not yet recruiting | ProbarE | Lund, 222 22, Sweden |
Withdrawn | ProbarE | Stockholm, 111 37, Sweden |
Not yet recruiting | Center For Diabetes, Academic Specialist Center | Stockholm, 113 65, Sweden |
Not yet recruiting | Akademiska Sjukhuset | Uppsala, 751 85, Sweden |
Withdrawn | Kliniska vetenskaper, DS | Danderyd, 182 57, Sweden |
Not yet recruiting | Carlanderska Sjukhuset | Göteborg, 405 45, Sweden |
Not yet recruiting | Dalecarlia Clinical Research | Rättvik, 795 30, Sweden |
Not yet recruiting | Regionshospitalet Herning | Herning, 7400, Denmark |
Not yet recruiting | Sydvestjysk Sygehus Esbjerg | Esbjerg, 6700, Denmark |
Not yet recruiting | Aarhus Universitetshospital, Skejby | Aarhus N, 8200, Denmark |
Not yet recruiting | Odense Universitetshospital | Odense C, DK-5000, Denmark |
Withdrawn | Hvidovre Hospital | Hvidovre, 2650, Denmark |
Not yet recruiting | Hvidovre Hospital | Hvidovre, 2650, Denmark |
Not yet recruiting | Nordsjællands Hospital | Hillerød, 3400, Denmark |
Not yet recruiting | Sykehuset Innlandet HF Hamar | Hamar, 2326, Norway |
Not yet recruiting | AKTIMED Helse AS | Hamar, 2317, Norway |
Not yet recruiting | Oslo Universitetssykehus HF, Rikshospitalet | Oslo, 0586, Norway |
Withdrawn | Spesialistsenteret Pilestredet Park | Oslo, 0176, Norway |
Not yet recruiting | Skedsmo Medisinske Senter | Skedsmokorset, 2020, Norway |
Withdrawn | Oslo Universitetssykehus HF, Rikshospitalet | Oslo, 0372, Norway |
Not yet recruiting | Stavanger Helseforskning AS | Stavanger, 4011, Norway |
Not yet recruiting | St. Olavs Hospital HF | Trondheim, 7006, Norway |
Not yet recruiting | Medizinische Universität Graz | Graz, 8036, Austria |
Not yet recruiting | Konventhospital Barmherzige Brüder Linz | Linz, 4021, Austria |
Not yet recruiting | Zentrum f. klinische Studien Dr. Hanusch GmbH | Wien, 1060, Austria |
Not yet recruiting | Universitätsklinikum St. Pölten | St. Pölten, 3100, Austria |
Not yet recruiting | Landeskrankenhaus Feldkirch | Feldkirch, 6807, Austria |
Not yet recruiting | Universitätsklinikum AKH Wien | Wien, 1090, Austria |
Not yet recruiting | Klinik Hietzing | Wien, 1130, Austria |
Not yet recruiting | Kantonsspital St. Gallen | St. Gallen, 9007, Switzerland |
Not yet recruiting | Inselspital Universitätsspital Bern | Bern, 3010, Switzerland |
Not yet recruiting | Centre Hospitalier Universitaire Vaudois (CHUV) | Lausanne, 1011, Switzerland |
Not yet recruiting | Turun yliopistollinen keskussairaala, kantasairaala | Turku, 20520, Finland |
Not yet recruiting | Health Step Finland Oy | Kuopio, 70100, Finland |
Not yet recruiting | Oulun yliopistollinen sairaala | Oulu, 90220, Finland |
Not yet recruiting | Seinäjoen keskussairaala | Seinäjoki, FIN 60220, Finland |
Not yet recruiting | Päijät-Hämeen keskussairaala | Lahti, 15850, Finland |
Not yet recruiting | Albert Schweitzer Ziekenhuis, locatie Zwijndrecht | ZWIJNDRECHT, 3331 LZ, Netherlands |
Not yet recruiting | Maxima Medisch Centrum, locatie Eindhoven | EINDHOVEN, 5600 PD, Netherlands |
Not yet recruiting | Albert Schweitzer Ziekenhuis, Locatie Dordwijk | DORDRECHT, 3318 AT, Netherlands |
Not yet recruiting | Academisch Medisch Centrum (AMC) | AMSTERDAM, 1105 AZ, Netherlands |
Primary Outcome
- Change from baseline in urine albumin-to-creatinine ratio (UACR) to the end of treatment (Visit 6)date_rangeTime Frame:Baseline and Visit 6 (28 days)
Secondary Outcome
- Frequency of treatment-emergent adverse events (TEAEs)date_rangeTime Frame:From the first treatment with the study intervention until 7 days after the last dose, up to 5 weeks
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
2