Chronic Kidney DiseasePhase 2ASSESS-CKDNCT04661917
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.
A Phase 2 study testing BAY2327949 in people with Chronic Kidney Disease and Diabetic Kidney Disease, run by Bayer at 36 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Chronic Kidney Disease, Diabetic Kidney Disease
- What is being tested?
- BAY2327949
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 36 sitesin 7 countries
- Study dates
- 31 May 2021to 19 May 2022
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 16Show fewer
- 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.
Trial locations and contacts
36 sites in 7 countries.
36 sites in 7 countries
Austria7 sites
Landeskrankenhaus Feldkirch
Feldkirch, Vorarlberg, 6807
Medizinische Universität Graz
Graz, Styria, 8036
Konventhospital Barmherzige Brüder Linz
Linz, Upper Austria, 4021
Universitätsklinikum St. Pölten
Sankt Pölten, 3100
Zentrum f. klinische Studien Dr. Hanusch GmbH
Vienna, 1060
Universitätsklinikum AKH Wien
Vienna, 1090
Klinik Hietzing
Vienna, 1130
Denmark6 sites
Aarhus Universitetshospital, Skejby
Aarhus N, 8200
Sydvestjysk Sygehus Esbjerg
Esbjerg, 6700
Regionshospitalet Herning
Herning, 7400
Nordsjællands Hospital
Hillerød, 3400
Hvidovre Hospital
Hvidovre, 2650
Odense Universitetshospital
Odense C, DK-5000
Norway6 sites
AKTIMED Helse AS
Hamar, 2317
Sykehuset Innlandet HF Hamar
Hamar, 2326
Oslo Universitetssykehus HF, Rikshospitalet
Oslo, 0586
Skedsmo Medisinske Senter
Skedsmokorset, 2020
Stavanger Helseforskning AS
Stavanger, 4011
St. Olavs Hospital HF
Trondheim, 7006
Finland5 sites
Health Step Finland Oy
Kuopio, 70100
Päijät-Hämeen keskussairaala
Lahti, 15850
Oulun yliopistollinen sairaala
Oulu, 90220
Seinäjoen keskussairaala
Seinäjoki, FIN 60220
Turun yliopistollinen keskussairaala, kantasairaala
Turku, 20520
Sweden5 sites
Carlanderska Sjukhuset
Gothenburg, 405 45
ProbarE
Lund, 222 22
Dalecarlia Clinical Research
Rättvik, 795 30
Center For Diabetes, Academic Specialist Center
Stockholm, 113 65
Akademiska Sjukhuset
Uppsala, 751 85
Netherlands4 sites
Academisch Medisch Centrum (AMC)
Amsterdam, 1105 AZ
Albert Schweitzer Ziekenhuis, Locatie Dordwijk
Dordrecht, 3318 AT
Maxima Medisch Centrum, locatie Eindhoven
Eindhoven, 5600 PD
Albert Schweitzer Ziekenhuis, locatie Zwijndrecht
Zwijndrecht, 3331 LZ
Switzerland3 sites
Inselspital Universitätsspital Bern
Bern, 3010
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, 1011
Kantonsspital St. Gallen
Sankt Gallen, Canton of St. Gallen, 9007
About this study
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
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.
Read more
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.
- Conditions
- Chronic Kidney Disease, Diabetic Kidney Disease
- Being tested
- BAY2327949, Placebo
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY2327949Drug
60 mg of BAY2327949 (2 tablets of 30 mg, orally) once daily for 28 days.
PlaceboDrug
Matching placebo orally once daily for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| BAY2327949 | Experimental | Participants will receive 60 mg of BAY2327949 (2 tablets of 30 mg) once daily for 28 days. Receives: Drug: BAY2327949 |
| Placebo | Placebo comparator | Participants will receive matching placebo once daily for 28 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in urine albumin-to-creatinine ratio (UACR) to the end of treatment (Visit 6)
Measured: Baseline and Visit 6 (28 days)
Secondary outcomes (1)
Frequency of treatment-emergent adverse events (TEAEs)
Measured: From the first treatment with the study intervention until 7 days after the last dose, up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start31 May 2021 (estimated)
- Primary completion25 Apr 2022 (estimated)
- Study completion19 May 2022 (estimated)
Why it stopped: Study withdrawn due to company decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04661917
- Sponsor's protocol ID
- 19225
- Other IDs
- 2020-002192-35
- Acronym
- ASSESS-CKD
- Status last verified
- May 2021
- First submitted
- 20 Nov 2020
- Last updated
- 21 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 21 May 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 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
- ClinicalTrials.gov ID
- NCT04661917
- Acronym / sponsor ID
- ASSESS-CKD / 19225
- Conditions
- Chronic Kidney Disease, Diabetic Kidney Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn due to company decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 31 May 2021 (estimated)
- Primary completion
- 25 Apr 2022 (estimated)
- Study completion
- 19 May 2022 (estimated)
- First posted
- 10 Dec 2020 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAY2327949 | Experimental | Drug: BAY2327949Participants will receive 60 mg of BAY2327949 (2 tablets of 30 mg) once daily for 28 days. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive matching placebo once daily for 28 days. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
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 |
|---|---|---|
| BAY232794960 mg of BAY2327949 (2 tablets of 30 mg, orally) once daily for 28 days. | Drug | BAY2327949 |
| PlaceboMatching placebo orally once daily for 28 days. | Drug | Placebo |
Primary outcome
Change from baseline in urine albumin-to-creatinine ratio (UACR) to the end of treatment (Visit 6)
Time frame: Baseline and Visit 6 (28 days)
1 secondary outcome
Frequency of treatment-emergent adverse events (TEAEs)
Time frame: From the first treatment with the study intervention until 7 days after the last dose, up to 5 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
- Individual participant dataSharing planned: Undecided. Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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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.
36 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 BAY2327949 in people with Chronic Kidney Disease and Diabetic Kidney Disease, run by Bayer at 36 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 5 inclusion and 16 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: withdrawn, as of the sponsor's last update on 21 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in Austria, Denmark, Norway, Finland, Sweden 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 was withdrawn before enrolling participants, so there are no results.
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 from baseline in urine albumin-to-creatinine ratio (UACR) to the end of treatment (Visit 6) (time frame: Baseline and Visit 6 (28 days)). 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 21 May 2021.