FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/02/102900 [Registered on: 03/02/2026] Trial Registered Prospectively
Last Modified On: 29/01/2026
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 BAY 3401016 Works and Its Safety in Participants With Alport Syndrome (ASSESS)  
Scientific Title of Study   A randomized, double-blind, placebo-controlled, parallel group Phase 2a study with an extension phase to evaluate the efficacy and safety of BAY 3401016 in participants aged 18 to 45 with Alport syndrome 
Trial Acronym  ASSESS 
Secondary IDs if Any  
Secondary ID  Identifier 
EU-CT Number: 2024-516471-33-00   Other 
IND: 172982  Other 
Protocol No.22419 Version no. 1.0 dated 26 Jun 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aleksandr Poskonnyi 
Designation  Country Head of Site Management, Clinical Operations, India 
Affiliation  Bayer Pharmaceuticals Private Limited  
Address  Pharmaceuticals Division, Research & Development, Bayer House, Central Avenue, Hiranandani Estate, Thane West

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

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

Thane
MAHARASHTRA
400607
India 
Phone  919967617940  
Fax    
Email  aleksandr.poskonnyi@bayer.com  
 
Source of Monetary or Material Support  
Bayer Pharmaceuticals Private Limited, Bayer House, Central Avenue, Hiranandani Estate, Thane - 400607, Maharashtra India  
 
Primary Sponsor  
Name  Bayer Pharmaceuticals Private Limited 
Address  Pharmaceuticals Division, Research & Development, Bayer House, Central Avenue, Hiranandani Estate, Thane West, Thane-400607, Maharashtra, India 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Argentina
Canada
China
Czech Republic
France
Germany
India
Italy
Japan
Poland
Portugal
Republic of Korea
Spain
United Kingdom
United States of America  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Arunkumar Subbiah   All India Institute of Medical Sciences (AIIMS), New Delhi   Department of Nephrology, AIIMS, Ansari Nagar, New Delhi – 110029
New Delhi
DELHI 		 91-9968969076

gmedaks@gmail.com  
Dr Atanu Pal   IPGME&R and SSKM Hospital   244, AJC Bose Road, Kolkata 700020, West Bengal
Kolkata
WEST BENGAL 		 91-9038080051

dratanup@gmail.com  
Dr ilangovan Veerappan  KG Hospital and PG Medical Institute & Research Centre   No-5, KG Hospital, Government Arts College Road, Coimbatore - 641018, Tamil Nadu
Coimbatore
TAMIL NADU 		 91-8754025648

ilangovanv@gmail.com 
Dr Siddharth Mavani   Mavani Research Center   204, Kairos, Opp. Mahatma Gandhi Labour Institute, Near Manav Mandir, Drive-in Road, Ahmedabad - 380052, Gujarat
Ahmadabad
GUJARAT 		 91-9825317953

msiddh@yahoo.co.in  
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Institute Ethics Committee  Submittted/Under Review 
Institutional Ethics Committee KG Hospital  Approved 
IPGMEandR Research Oversight Committee  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: Q878||Other specified congenital malformation syndromes, not elsewhere classified, (2) ICD-10 Condition: N18||Chronic kidney disease (CKD),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BAY 3401016 for subcutaneous or intravenous injection  Intravenous loading dose of 700 mg BAY 3401016 before the first subcutaneous administration, followed by weekly subcutaneous administration of 225 mg BAY 3401016 for 24 weeks.  
Comparator Agent  Placebo to BAY 3401016 for subcutaneous or intravenous injection  Intravenous loading dose of 700 mg placebo before the first subcutaneous administration, followed by weekly subcutaneous administration of placebo for 24 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Participants must be 18 to 45 years of age inclusive, at the time of signing the informed consent.
2. Participants with Alport Syndrome - XLAS (male) or ARAS (male or female)
3. eGFR greater then or equal to 45 mL/min/1.73m2 at screening.
4. UACR greater then or equal to 500mg/g at screening.
5. Treatment with ACEi and/or ARB started at least 12 weeks before screening with stable dosing regimen from at least 4 weeks before screening until first administration of study intervention.
6. If treated with a SGLT2i in addition to ACEi and/or ARB, treatment should have started at least 12 weeks before screening and dosing regimen should be stable from at least 4 weeks before screening until before first administration of study intervention.
7. Body mass index (BMI) within the range 18 and less then or equal to 35 kg/m2. 
 
ExclusionCriteria 
Details  1. Primary cause for chronic kidney disease is different from AS (e.g. diabetic, IgA, lupus, hypertensive or immune nephropathy) as assessed by the investigator.
2. ESRD defined by prior renal transplantation or the need for renal replacement therapy by hemodialysis.
3. Clinically significant illness that could have influence on the safety of the participant and/or interfere with the study objectives.
4. History or current existence of malignancy. A history of localized basal cell or squamous cell carcinoma, cervical carcinoma in situ that has been excised or appropriately treated, or another completely excised malignant lesion with a low probability of recurrence is not considered exclusionary.
5. Known hypersensitivity to any study intervention (active substances or excipients of the preparations) used in the study.
6. Participants with history of severe allergies, multiple drug allergies or non-allergic drug reactions including allergies affecting the lower respiratory tract – allergic asthma, allergies requiring therapy with corticosteroids or urticaria.
7. Participants with active skin disorders (e.g. atopic dermatitis, severe acne).
8. Intake of mineralocorticoid receptor antagonists or endothelin receptor antagonists within 30 days or 5 half-lives of the active study intervention, whichever is longer, before screening.  
 
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 objective of the study is to assess the effect of BAY 3401016 on albuminuria in participants with Alport Syndrome  UACR ratio to baseline averaged over 16, 20 and 24 weeks of treatment. 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary objective of the study is to investigate the safety and tolerability of BAY 3401016 in participants with Alport Syndrome  Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="12" 
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)   09/02/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  19/11/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   Alport Syndrome is a genetic disorder causing progressive kidney disease, hearing loss, and eye abnormalities due to mutations in the COL4A3, COL4A4, or COL4A5 genes. Alport Syndrome can be inherited in X-linked, autosomal recessive, or autosomal dominant patterns, with X-linked and autosomal recessive forms typically being more severe. Current treatments mainly manage symptoms using Angiotensin-Converting Enzyme (ACE) inhibitors and Angiotensin Receptor Blockers (ARBs) to reduce proteinuria and protect kidney function. Sema3A, a soluble protein in the Semaphorin family, is expressed in the kidneys and regulates the actin cytoskeleton. In Alport Syndrome, COL4 mutations lead to stress in podocytes, disrupting cytoskeletal dynamics and causing hematuria, albuminuria, and renal fibrosis Recombinant Sema3A has been shown to decrease slit-diaphragm protein interactions and induce podocyte apoptosis, while its inhibition improves albuminuria and podocyte health. Elevated urinary Sema3A levels correlate with kidney disease severity. Overall, inhibiting Sema3A could provide a novel therapeutic approach for Alport Syndrome, distinct from existing Renin-Angiotensin-Aldosterone System (RAAS) targeting therapies. BAY 3401016 is a humanized monoclonal antibody targeting Sema3A, developed for the treatment of Alport Syndrome.

Study 22419 ASSESS study is a randomized, double-blind, placebo-controlled and a parallel group Phase 2a study with an extension phase to evaluate the efficacy and safety of BAY 3401016 in participants aged 18 to 45 years with Alport syndrome. The aim of this Phase 2a study is to explore if BAY 3401016 can reduce the decline of kidney function in participants with Alport syndrome who are at risk of fast disease progression. The study will also investigate the safety of repeat dose administration of BAY 3401016 in this population. Patients with fast progressing Alport Syndrome, characterized by rapid deterioration of kidney function, are at high risk of developing End Stage Renal Disease (ESRD) in early adulthood despite treatment with RAAS inhibitors as current standard of care. BAY 3401016 shows promise in stabilizing glomerular basement membrane function by decreasing free Sema3A, thus potentially slowing the progression to ESRD. The aim of this Phase 2a study is to explore if BAY 3401016 can reduce the decline of kidney function in a group of Alport Syndrome participants who are at risk of fast disease progression. The study will also investigate the pharmacokinetics (PK) and safety of repeat dose administration of BAY 3401016 in this population. The Phase 2a study is subdivided into 2 parts, Part A and Part B. The objective of Part A is to evaluate the effect on kidney function and safety of repeated doses of BAY 3401016 in participants with AS. Participants will be randomized 1:1 in a double-blind fashion to active treatment with repeated doses of BAY 3401016 or to placebo. Placebo control and double blinding are used to control for observer and subject bias, and randomization to control for assignment bias. The aim of Part B is to assess the long-term safety and PK of BAY 3401016. An open-label design with 24 weeks of treatment and without a control arm is considered adequate for these objectives.
  
Close