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CTRI Number  CTRI/2024/11/076672 [Registered on: 12/11/2024] Trial Registered Prospectively
Last Modified On: 03/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A Study to Learn About How Well BAY3283142 Works and Its Safety in Participants With Chronic Kidney Disease (ALPINE 1) 
Scientific Title of Study   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 Acronym  ALPINE-1 
Secondary IDs if Any  
Secondary ID  Identifier 
2023-505755-40-00  EudraCT 
CT/24/000079  DCGI 
Protocol No.: 22040 Version No. 2.0 dated 16-Nov-2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aleksandr Poskonnyi 
Designation  Country Head, Site Management, India 
Affiliation  Bayer Pharmaceuticals Private Limited 
Address  Pharmaceuticals Division, Research & Development, Pharmaceuticals Bayer House, Central Avenue, Hiranandani Estate, Thane MAHARASHTRA 400607 India

Thane
MAHARASHTRA
400607
India 
Phone  919967617940  
Fax    
Email  aleksandr.poskonnyi@bayer.com  
 
Details of Contact Person
Scientific Query  
Name  Aleksandr Poskonnyi 
Designation  Country Head, Site Management, India 
Affiliation  Bayer Pharmaceuticals Private Limited 
Address  Pharmaceuticals Division, Research & Development, Pharmaceuticals Bayer House, Central Avenue, Hiranandani Estate, Thane MAHARASHTRA 400607 India

Thane
MAHARASHTRA
400607
India 
Phone  919967617940  
Fax    
Email  aleksandr.poskonnyi@bayer.com  
 
Details of Contact Person
Public Query  
Name  Aleksandr Poskonnyi 
Designation  Country Head, Site Management, India 
Affiliation  Bayer Pharmaceuticals Private Limited 
Address  Pharmaceuticals Division, Research & Development, Pharmaceuticals Bayer House, Central Avenue, Hiranandani Estate, Thane MAHARASHTRA 400607 India

Thane
MAHARASHTRA
400607
India 
Phone  919967617940  
Fax    
Email  aleksandr.poskonnyi@bayer.com  
 
Source of Monetary or Material Support  
Bayer AG, Kaiser-Wilhelm-Allee 1, 51368 Leverkusen, Germany  
 
Primary Sponsor  
Name  Bayer Pharmaceuticals Private Limited  
Address  Pharmaceuticals Division, Research & Development, Pharmaceuticals Bayer House, Central Avenue, Hiranandani Estate, Thane : 400607. Maharashtra, India. 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Argentina
Belgium
China
Greece
India
Italy
Japan
Portugal
Singapore
Slovakia
Spain
Sweden
United Kingdom
United States of America
Republic of Korea  
Sites of Study
Modification(s)  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Arun kumar Subbiah  All India Institute of Medical Sciences  New Delhi Sri Aurobindo Marg, Ansari Nagar East, New Delhi, Delhi - 110029
New Delhi
DELHI 		 9968969076

gmedaks@gmail.com 
Dr Atanu Pal  IPGME&R SSKM hospital  244 Acharya J. C. Bose Road – Kolkata, West Bengal - 700020
Kolkata
WEST BENGAL 		 9433121697

dratanupal@gmail.com 
Dr L Sreenivasa Murthy  Life Care Hospital and Research Centre  2748-2152, M.L.N Enclave, 16th E Cross Road, 8th Main, D-Block Next to Corportion Bank, Sahakarnagar Bangalore, Karnataka - 560092
Bangalore
KARNATAKA 		 9448051046

drlsm@lcrc.in 
Dr V Mohan  Madras Diabetes Research Foundation  No 4, Conran Smith Road, Gopalapuram, Chennai, Tamil Nadu – 600086
Chennai
TAMIL NADU 		 9104428352634

drmohans@diabetes.ind.in 
Dr Siddharth Mavani  Mavani Research Center  204, Kiros, Opp. Mahatma Gandhi Labour Institute, Near Manav Mandir, Drive in Road Ahmedabad, Gujarat - 380052
Ahmadabad
GUJARAT 		 9825317935

msiddh@yahoo.co.in 
Dr Dinesh Khullar  Max Super Speciality Hospital  Press enclave Road, Saket New Delhi, Delhi - 110017
New Delhi
DELHI 		 9810124066

drdineshkhullar@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Institute Ethics Committee, All India Institute of Medical Sciences,  Approved 
Institutional Ethics Committee of Madras Diabetes Research Foundation  Approved 
IPGMEandR Research Oversight Committee  Approved 
Life Care Hospital Institutional Review Board  Approved 
Max Healthcare Ethics Committee (MHEC)  Approved 
Sangini Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N18||Chronic kidney disease (CKD),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BAY 3283142 Coated immediate-release tablet  2.5 mg or 5.0 mg or 10.0 mg or 15.0 mg, or 20.0 mg, once daily, orally up to 16 weeks 
Comparator Agent  Placebo to BAY 3283142 Coated immediate-release tablet  2.5 mg or 5.0 mg or 10.0 mg or 15.0 mg, or 20.0 mg, once daily, orally up to 16 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Participants aged ≥18 years, male or female (not of child-bearing potential)
2. CKD patients with eGFR more than or equal 20 and less than or 75 ml/min/1.73 m² and UACR more than or equal 200 mg/g and less than 3000 mg/g at screening visit 
 
ExclusionCriteria 
Details  1. Hepatic impairment (AST or ALT more than 3x the ULN; or total bilirubin more than 2x ULN) at Screening
2. Stroke, TIA, ACS, or hospitalization for worsening heart failure in the last 3 months prior to screening
- Treatment with the highest tolerated labeled dose of either angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blockers (ARB), unless such treatment is either not tolerated or contraindicated. Treatment dose must be stable dose for at least 4 weeks before Screening with no planned change of the therapy during the study
- If the participant receives any of the following treatments it should be stable for 4 weeks prior to Screening: sodium-glucose co-transporter-2 (SGLT2) inhibitor, finerenone, diuretics, endothelin-receptor antagonists, or glucagon-like peptide (GLP) receptor agonist

3. SBP less than 100 mmHg at Visit 2 (baseline)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
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  Up to 24 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Efficacy - • To investigate the course of eGFR over time
• To investigate the mean change from baseline in UACR over time.
Safety - To investigate the overall safety and tolerability of treatment with BAY 3283142 compared with placebo in addition to SoC 		 Up to 24 weeks 
 
Target Sample Size   Total Sample Size="1400"
Sample Size from India="114" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   25/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  22/08/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Chronic Kidney Disease (CKD) impacts 10% to 12% of the global population and it is a progressive condition, with albuminuria as important risk factor for a more rapid decline in kidney function.
Prevention of kidney disease progression and decrease in cardiovascular risk will remain an unmet clinical need among patients with CKD requiring new treatments with agents targeting new mechanisms of action.
BAY 3283142 is a soluble guanylate cyclase (sGC) activator under development for treatment of CKD to reduce proteinuria and improve cardiovascular and renal outcomes of patients.
It is anticipated that activation of sGC by BAY 3283142 under conditions of oxidative stress that are prevailing in CKD, will reduce CV mortality and progression of kidney disease in patients suffering from CKD by reducing intraglomerular filtration pressure, albuminuria, and kidney fibrosis.
The primary objective of this study is to estimate and assess a dose-response relationship of BAY 3283142 (2.5 mg, 5 mg, 10 mg, 15 mg or 20 mg Once Daily) compared with placebo in the primary endpoint of mean change from baseline in Urine albumin-creatinine ratio (UACR) at Week 16 in CKD patients, with or without diabetes, treated on top of SoC including RAS inhibitor, SGLT2 inhibitor and/or finerenone. This study will support dose selection for the planned Phase 3 study in CKD.
 
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