To evaluate the efficacy of BAY 2327949 to decrease urine albumin-to-creatinine ratio (UACR) in patients with chronic kidney disease.To evaluate the safety and tolerability of BAY 2327949.
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
- Glucose metabolism disorders (incl diabetes mellitus)
- Nephropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Decrease in UACR at end of treatment (Visit 6) versus baseline (Visit 2).
Secondary outcome
Frequency of treatment- emergent adverse events (TEAEs).
Background summary
Chronic kidney disease can cause narrowing of the blood vessels in the kidneys,
which impairs the microcirculation in the kidneys. Less oxygen is distributed,
which is harmful to the kidneys. BAY 2327949 can decrease the narrowing of the
blood vessels which may improve the microcirculation in the kidneys..
Study objective
To evaluate the efficacy of BAY 2327949 to decrease urine albumin-to-creatinine
ratio (UACR) in patients with chronic kidney disease.
To evaluate the safety and tolerability of BAY 2327949.
Study design
This is a randomized, double-blind, parallel-group, placebo-controlled,
multi-center study.
Intervention
BAY2327949 60 mg (2 tablets of 30 mg, orally) once daily for 28 days.
Placebo: Matching placebo orally once daily for 28 days.
Study burden and risks
Patient's burden consists of the extra time investment during study
participation.
The patient will be asked to come to the hospital 9 times in 2,5 months.
The patient could find the following activities as inconvenient:
- the quantity of the urine collection: up to 8x 3 containers
- the lab activities: up to 7 blood samples and 1x pharmacogenetic blood sample
and
- up to 7x PK and/or biomarker samples (serum en plasma)
As BAY 2327949 is still in early development, there are no associated side
effects to BAY 2327949. However there were adverse events reported in 2
completed trails with BAY 2327949. These adverse events are mentioned in the
patient information form.
When the burden and risks are adversely experienced by the patient, the patient
can stop the study participation, at any time, without providing an explicit
reason and without any consequences for the further medical care.
Energieweg 1
Mijdrecht 3641 RT
NL
Energieweg 1
Mijdrecht 3641 RT
NL
Listed location countries
Age
Inclusion criteria
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 class III *
IV), or hospitalization for worsening heart failure in the last 3 months prior
to signing the 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2020-002192-35-NL |
CCMO | NL74997.100.20 |