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Protocol Number22040
Active

2024-09-30 - 2026-06-30

Phase II

Not yet recruiting5

Recruiting1

ICD-10N18.4

Chronic kidney disease, stage 4 (severe)

ICD-10N18.5

Chronic kidney disease, stage 5

ICD-10N18.6

End stage renal disease

ICD-10N18.9

Chronic kidney disease, unspecified

ICD-9585

Chronic renal failure

A Phase 2b dose-finding, randomized, placebo-controlled, double-blind study to evaluate efficacy and safety of BAY 3283142 on top of standard of care in reducing albuminuria in patients with chronic kidney disease

  • Trial Applicant

    BAYER TAIWAN COMPANY LTD.

  • Sponsor

    Bayer AG

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator 江珠影 Division of Endocrinology
Far Eastern Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 杜奕德 Division of Nephrology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 張恬君 Division of Endocrinology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 李建德 Division of Nephrology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 杜思德 Division of Endocrinology
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Mai-Szu Wu
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

chronic kidney disease

Objectives

The primary efficacy objective is to estimate and assess a dose-response relationship in the primary endpoint of mean change in UACR from baseline after 16 weeks of treatment with BAY 3283142 compared with placebo in addition to SoC in CKD patients to support the dose selection for Phase 3

Test Drug

tablets

Active Ingredient

Nurandociguat
安慰劑

Dosage Form

110
110
110
110

Dosage

1.25mg
5mg
10mg
0mg

Endpoints

The primary efficacy endpoint is the
change from baseline to Week 16 in the
logarithm of UACR

Inclution Criteria

Type of participant and disease characteristics
2. eGFR (CKD-(3,IRUPXOD •DQGP/PLQP2 at Screening
Note: One re-assessment of eGFR based on central laboratory values is allowed
during the Screening period
For country-specific requirements for Japan, refer to Section 
3. 8$&5•PJJDQGmg/g • mg/mmol to <395.5 mg/mmol) as
determined by the geometric mean (as calculated by the central laboratory) of
3 morning void urine specimens obtained at Screening
Note: This should be assessed by central laboratory analysis in at least 2 out of 3 first
morning void samples. If one of the 3 UACR measurements is missing but the other 2
are valid, these values can be used to assess the participant´s eligibility for this study
One re-assessment of UACR based on central laboratory values is allowed during the
Screening period.

Exclusion Criteria

1. SBP <100 mmHg at Visit 2 (baseline)
Note: The mean of the 3 readings will be used to assess SBP (see also Section 8.3.2).
2. Patients with a tendency for clinically relevant orthostatic hypotension at Screening
and Visit 2 (baseline) as judged by the investigator
3. 6%3•PP+JXQOHVVWUHDWHGZLWK•EORRGSUHVVXUHORZHULQJPHGLFDWLRQVDW
Screening or at Visit 2 (baseline).
Note: The mean of the 3 readings will be used to assess SBP (see also Section 8.3.2).
4. History of secondary hypertension other than CKD (i.e., renal artery stenosis, primary
aldosteronism, or pheochromocytoma) at Screening
5. Stroke, transient ischemic cerebral attack, acute coronary syndrome, or hospitalization
for worsening heart failure, in the last 3 months prior to Screening
6. NYHA Class IV Congestive Heart Failure at either Screening or Visit 2 (baseline)
7. Hepatic impairment corresponding to Child-Pugh B or C or other significant liver
disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis as indicated by e.g.
AST or ALT >3x ULN or total bilirubin >2x ULN) at Screening (based on central
laboratory values)
8. Polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis and any
other kidney disease requiring immunosuppressive therapy within 6 months prior to
Screening
9. HbA1c >11% at Screening (based on central laboratory values)
10. Any other history, condition, therapy, or uncontrolled intercurrent illness which could
in the opinion of the investigator affect compliance with study requirements
11. Active malignancy and/or other condition limiting life expectancy to less than
12 months

The Estimated Number of Participants

  • Taiwan

    56 participants

  • Global

    1400 participants

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