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
- Conditions
- chronic kidney diseasedamaged kidney100822061001842410029149
- Registration Number
- NL-OMON49199
- Lead Sponsor
- Bayer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 15
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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Decrease in UACR at end of treatment (Visit 6) versus baseline (Visit 2).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Frequency of treatment- emergent adverse events (TEAEs).</p><br>