CTRI/2025/08/092248 [Registered on: 04/08/2025] Trial Registered Prospectively
Last Modified On:
01/10/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Other
Public Title of Study
The study is to evaluate the effect of felzartamab(active drug)compared to placebo (dummy drug) on proteinuria in Adult patients with Immunoglobulin A nephropathy (IgAN).
Scientific Title of Study
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Felzartamab in Adults with IgA Nephropathy
Trial Acronym
PREVAIL
Secondary IDs if Any
Secondary ID
Identifier
2024-519345-30-00
Other
299IG301_Protocol #V2.1_13Feb2025
Protocol Number
NCT06935357
ClinicalTrials.gov
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Rashmi Chitgupi
Designation
Country Head
Affiliation
PPD Pharmaceutical Development India Private Limited, part of Thermo Fisher Scientific
Address
PPD Pharmaceutical Development India Pvt Ltd,part of Thermo Fisher Scientific
102 A wing Fulcrum Hiranandani Business Park
Sahar Road
Andheri East
Mumbai MAHARASHTRA 400099 India
Phone
912268804200
Fax
91 22 6645 9321
Email
Rashmi.Chitgupi@Thermofisher.com
Details of Contact Person Scientific Query
Name
Rashmi Chitgupi
Designation
Country Head
Affiliation
PPD Pharmaceutical Development India Private Limited, part of Thermo Fisher Scientific
Address
PPD Pharmaceutical Development India Pvt Ltd,part of Thermo Fisher Scientific
102 A wing Fulcrum Hiranandani Business Park
Sahar Road
Andheri East
Mumbai MAHARASHTRA 400099 India
Phone
912268804200
Fax
91 22 6645 9321
Email
Rashmi.Chitgupi@Thermofisher.com
Details of Contact Person Public Query
Name
Rashmi Chitgupi
Designation
Country Head
Affiliation
PPD Pharmaceutical Development India Private Limited, part of Thermo Fisher Scientific
Address
PPD Pharmaceutical Development India Pvt Ltd,part of Thermo Fisher Scientific
102 A wing Fulcrum Hiranandani Business Park
Sahar Road
Andheri East
Mumbai MAHARASHTRA 400099 India
Phone
912268804200
Fax
91 22 6645 9321
Email
Rashmi.Chitgupi@Thermofisher.com
Source of Monetary or Material Support
Biogen Idec Research Limited, 5 Foundation Park Roxborough Way Maidenhead, Berkshire
SL6 3UD United Kingdom
Primary Sponsor
Name
Biogen Idec Research Limited
Address
5 Foundation Park Roxborough Way Maidenhead, Berkshire
SL6 3UD United Kingdom
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
Nil
Nil
Countries of Recruitment
United States of America Argentina Australia Belgium Brazil Bulgaria Canada China Colombia Croatia Czech Republic France Germany Greece India Italy Japan Malaysia New Zealand Philippines Poland Portugal Republic of Korea Spain Taiwan United Kingdom Turkey
Sites of Study
No of Sites = 18
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Vinay Rathore
All India Institute of Medical Sciences ( AIIMS )
Department of Nephrology, C-Block , room no 1, gate no 4 All India Institute of Medical Sciences (AIIMS), G.E. Road, Tatibandh, Raipur-492099, Chhattisgarh Raipur CHHATTISGARH
9914699651
vinayrathoredm@aiimsraipur.edu.in
Dr Suceena Alexander
Christian Medical College - Ranipet Campus
Room number 37, Nephrology OPD, A102, First floor, Ranipet district, Tamil Nadu, 632517 Vellore TAMIL NADU
914162222102
suceena@gmail.com
Dr Biju K Gopinath
Government Medical College, Kozhikode
#404,
Department of Nephrology Government Medical College, Department of Nephrology Super Speciality Block Kozhikode- 67 3008, Kerala, India Kozhikode KERALA
9778425559
drbijugopinath01@gmail.com
Dr Ragi Krishnan G
Government Medical College, Thiruvananthapuram
Department of Nephrology,Government Medical College, Thiruvananthapuram, Kerala - 695011 Thiruvananthapuram KERALA
9778425561
drragiresearch@gmail.com
Dr Mahesh Eshwarappa
M.S. Ramaiah Medical College and Hospital
Department of Nephrology, Ground Floor, Room number 10, Ramaiah Memorial Hospital, M S Ramaiah Nagar, MSRIT Post, Bengaluru-560054 Bangalore KARNATAKA
8023608888
manasnephro2002@yahoo.co.in
Dr Vishwanath S
Manipal Hospital
Department of Nephrology ,#98, Old Airport Road, Bangalore - 560017, Karnataka, India Bangalore KARNATAKA
9845174866
vishwanath.siddini@manipalhospitals.com
Dr Dinesh Khullar
Max Super Speciality Hospital - Saket
Department of Nephrology,Max Super Speciality Hospital, Saket (West Block), (A unit of Max Healthcare Institute Limited), 1 Press Enclave Road, Saket, New Delhi – 110017, India New Delhi DELHI
9810124066
drdineshkhullar@gmail.com
Dr Sishir Gang
Muljibhai Patel Society for Research in Nephro/Urolog, c/o Muljibhai Patel Urological Hospital
1,2 Clinical research Room, Nephrology Department, Dr. Virendra Desai Road, Nadiad, 387001, Gujarat, India Kheda GUJARAT
9824360818
sishirgang@mpuh.org
Dr Pinaki Mukhopadhyay
Nil Ratan Sircar Medical College and Hospital
NRS Medical College and Hospital, Department of Nephrology, 138, A.J.C Bose Road, Kolkata-700014 Kolkata WEST BENGAL
9231978078
drpinaki@yahoo.com
Dr Sree Bhushan Raju Devaraju
Nizams Institute of Medical Sciences
Department of Nephrology,Nizams Institute of Medical Sciences, Punjagutta,
Hyderabad- 500082, Telangana, India
Hyderabad TELANGANA
9848492951
sreebhushan@hotmail.com
Dr Avinash Ignatius
Noble Hospital Pvt. Ltd.
1st floor, Nephrology OPD, Noble Annex, Noble Hospital Pvt. Ltd., 153, Magarpatta City Road, Pune – 411013, Maharashtra, India Pune MAHARASHTRA
9823101982
dr_ignatius@yahoo.co.in
Dr Manisha Sahay
Osmania General Hospital
Department of Nephrology, QQDC Building, 3rd Floor, Afzalgunj, 500012, Hyderabad, Telangana, India Hyderabad TELANGANA
9849097507
drmanishasahay@gmail.com
Dr Raja Ramachandran
Postgraduate Institute of Medical Education & Research (PGIMER)
Postgraduate Institute of Medical Education & Research (PGIMER),
Department of Nephrology, Ground Floor, C-Block, Nehru Hospital, Chandigarh, Sector-12, 160012, India
Chandigarh CHANDIGARH
9216958874
drraja_1980@yahoo.co.in
Dr Narayan Prasad
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Department of Nephrology, Second floor, Research Room, Raibareli Road Lucknow-226014, Uttar Pradesh Lucknow UTTAR PRADESH
8884122456
narayan@sgpgi.ac.in
Dr Tukaram Jamale
Seth G S Medical College and K E M Hospital
Ward 34A, Third Floor, Old building, Department of Nephrology,
Seth GSMC and KEM Hospital, Mumbai- 400012, Maharashtra, India
Mumbai MAHARASHTRA
9167460362
tukaramjamale@yahoo.co.in
Dr Anurag Gupta
Sir Ganga Ram Hospital
Department of Nephrology, clinical Research room,5th floor, near doctor Forum, Sir Ganga Ram Hospital Marg, Rajinder Nagar, New Delhi – 110060 New Delhi DELHI
8800260446
Dranuragg1@yahoo.com
Dr Dhananjai Agrawal
SMS Superspeciality Hospital, Attached to SMS Medical College
Room No 507, 5th Floor, Department of Nephrology, SMS Superspeciality Hospital, Attached to SMS Medical College, Vivekanand Marg, C-Scheme, Jaipur-302001 Jaipur RAJASTHAN
9887870552
dhananjaynephro@gmail.com
Dr Kamal Ramesh Goplani
Zydus Hospitals & Healthcare Research Pvt. Ltd.
14th Floor, Clinical Research Department Room No1410,Zydus Hospitals & Healthcare Research Pvt. Ltd.
Zydus Hospitals Road, S.G.Highway, Thaltej, Ahmedabad-380054, Gujarat, India
Ahmadabad GUJARAT
Ethics Committee, M S Ramaiah Medical College and Hospitals
Submittted/Under Review
Human Ethics Committee, Government Medical College, Thiruvananthapuram
Submittted/Under Review
Institution Ethics Committee AIIMS, Raipur
Submittted/Under Review
Institutional Ethics Committee
Submittted/Under Review
Institutional Ethics Committee of Sanjay Gandhi Postgraduate Institute of Medical Sciences
Submittted/Under Review
Institutional Ethics Committee, Government Medical College Kozhikode
Submittted/Under Review
Institutional Ethics Committee, Nil Ratan Sircar Medical College
Submittted/Under Review
Institutional Ethics Committee, Osmania Medical College
Approved
Institutional Ethics Committee, PGIMER
Submittted/Under Review
Institutional Ethics Committee, SMS Medical College & Attached Hospital
Approved
Institutional Review Board (IRB) Christian Medical College,
Submittted/Under Review
Max Healthcare Ethics Committee (MHEC)
Approved
Muljibhai Patel Society for Research in Nephro-Urology Ethics Committee
Approved
NIMS Institutional Ethics Committee Nizams Institute of Medical Sciences
Approved
Noble Hospital Institutional Ethics Committee
Approved
Sir Ganga Ram Hospital Ethics Committee
Submittted/Under Review
Zydus Hospital Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: N08||Glomerular disorders in diseases classified elsewhere,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Felzartamab
The 9-dose regimen of Felzartamab is associated with a 24-week treatment period that ends at Week 24 and administered intravenously (IV) at 0, 1, 2, 3, 4, 8, 12, 16, and 20. The felzartamab dose will be based on body weight on a tiered scale to match exposures associated with 16 mg/kg.
One vial of reconstituted felzartamab contains 325 mg felzartamab
Comparator Agent
Placebo
The 9-dose regimen of Placebo is associated with a 24-week treatment period that ends at Week 24 and administered intravenously (IV) at 0, 1, 2, 3, 4, 8, 12, 16, and 20.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. Biopsy-confirmed diagnosis of IgAN within the past 10 years prior to signature of the informed consent form (ICF). For participants with diabetes mellitus type 2, biopsy confirmation of IgAN diagnosis must be done within the past 24 months prior to signing the ICF.There is no upper limit of age
2. An eGFR greater than or equal to 30 milliliters per minute per 1.73 square meters at Screening as calculated using the 2021 chronic kidney disease epidemiology (CKD-EPI) creatinine formula. An eGFR of greater than or equal to 20 and less than 30 milliliters per minute per 1.73 square meters is acceptable for the cohorts 3 and 4.
3. Proteinuria of greater than or equal to 1.0 gram per day or UPCR greater than or equal to 0.8 gram per gram as assessed by an adequate 24-hour urine collection.
4. Clinically stable on a maximally tolerated dose or maximally approved dose of angiotensin-converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) for at least 12 weeks prior to Screening, or intolerant of ACEI or ARB. If intolerant, this must be discussed with the Medical Monitor prior to randomization. Participants may also be using sodium-glucose cotransporter-2 inhibitors (SGLT2is), endothelin receptor antagonists (ERAs) approved for the treatment of IgAN, and/or mineralocorticoid receptor antagonists (MRAs) as long as the dose is stable for at least 12 weeks prior to Screening. Participants should remain on stable doses of these background medications for the duration of the study. Once the ICF is signed and thereafter, the doses cannot be changed during the study nor the drugs discontinued except if deemed related to an AE. Participants using sparsentan will not be permitted to use simultaneous ACEI or ARB medication.
ExclusionCriteria
Details
1. Secondary forms of IgAN, indicated by the presence of any other systemic disease potentially leading to IgA deposits as determined by the Investigator.
2. History of rapidly progressive variant of IgAN, defined as eGFR loss by greater than 50% per 3 months and not explained by changes in renin-angiotensin system (RAS) blockade or other factors.
3. Nephrotic syndrome presumed to be due to minimal change disease (MCD) variant.
4. Concomitant other progressive glomerulonephritis or non-immunologic glomerular disease such as diabetic nephropathy.
5 Type 2 diabetes mellitus with Hemoglobin A1c (HbA1c) greater than 8% at Screening, or evidence of diabetic nephropathy on biopsy, history of diabetic microvascular or macrovascular disease (eg, diabetic retinopathy, peripheral neuropathy).
6 Any diagnosed or suspected immunosuppressed or immunodeficient state such as asplenia, human immunodeficiency virus (HIV), primary immunodeficiencies, organ or bone marrow transplantation, with the exception of corneal transplants.
7 Previously treated with immunosuppressive or other immunomodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus, or systemic corticosteroids exposure (greater than 7.5 milligrams per deciliter [mg/d] prednisone/prednisolone equivalent) within 4 months (or 12 months for rituximab) prior to Screening.
8 Participants currently treated with oral budesonide. Participants who have stopped this therapy greater than or equals to 4 months prior to Screening may be eligible.
9. Active clinically significant infections, known history of recurrent clinically significant infection, or Screening laboratory evidence consistent with an active infection, or IV anti-infectives (antibacterials, antiviral or antifungals). Participants with a history of opportunistic infections are excluded.
10 Hypogammaglobulinemia: Serum Immunoglobin G (IgG) less than 6.0 gram per litre, at Screening.
Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Method of Generating Random Sequence
Stratified randomization
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator and Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
Percent Change From Baseline in Proteinuria as Measured by the Urine Protein: Creatinine Ratio (UPCR)
Baseline up to Week 36
Secondary Outcome
Outcome
TimePoints
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Values Calculated Using the Chronic Kidney Disease Epidemiology (CKD-EPI) Creatinine Equation
Baseline up to Week 104
Percentage of Participants Achieving Complete Response (CR)
CR is defined as a UPCR value (based on 24-hour urine collection) of greater than 0.5 gram per gram (g/g), a reduction in UPCR of greater than and equals to 50%, and a stable eGFR (decrease from baseline in eGFR of less than and equals to 25%). Baseline up to Week 104
Percentage of Participants who Progressed to Kidney Malfunction.
The percentage of participants progressing to kidney malfunction will be reported based on one of the following, 1. greather than or equals to 40% Reduction in eGFR Sustained for greaterthan or equals to 30 Days, 2. eGFR less than 15 mL/min/1.73m^2 for greater than or equals to 30 Days, 3. Undergoing Dialysis for greater than or equals to 30 Days, 4. Undergoing Kidney Transplantation, 5. Died From Kidney Failure
Baseline up to Week 104
Percentage of Participants Requiring Rescue Therapy
Baseline up to Week 104
Change From Baseline in eGFR Values Calculated Using the CKD-EPI Creatinine Equation
Baseline up to Week 52
Felzartamab Serum Concentrations Over Time
Predose and at multiple timepoints postdose up to Week 36
Number of Participants with Anti-Drug Antibodies (ADAs) Against Felzartamab
Baseline up to Week 104
Percentage of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE)
Baseline up to Week 104
Number of Participants With Clinically Significant Change From Baseline in Vital Signs Abnormalities
Baseline up to Week 104
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Baseline up to Week 104
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Abnormalities
Baseline up to Week 104
Number of Participants With Clinically Significant Change From Baseline in Physical Examinations Abnormalities
Baseline up to Week 104
Target Sample Size
Total Sample Size="454" Sample Size from India="25" 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 3
Date of First Enrollment (India)
15/10/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
29/05/2025
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="4" Months="6" Days="21"
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
In this study, researchers will learn more about the use of felzartamab in participants with immunoglobulin A nephropathy (IgAN). This study will focus on participants who have protein in their urine (proteinuria) as a result of damaged kidneys.
The main goal of the study is to learn about the effect felzartamab has on proteinuria.
The main question that researchers want to answer is:
• How much does the amount of protein in the urine change from the start of the study to Week 36?
Researchers will learn about the effect felzartamab has on the kidneys’ ability to filter blood. They will also learn more about the safety of felzartamab and how it is processed by the body.
The study will be done as follows:
• Participants will be screened to check if they can join the study. Participants will be randomized to receive either felzartamab or a placebo. A placebo looks like the study drug but contains no real medicine.
• Neither the researchers nor the participants will know what the participants will receive.
• Participants will receive felzartamab or placebo as intravenous (IV) infusions.
• Afterwards, participants will enter a follow-up period.
• In total, participants will have 17 study visits. Participants will stay in the study for about 2 years.
The primary objective of the study is to evaluate the efficacy of felzartamab compared to placebo on proteinuria in participants with Immunoglobulin A nephropathy (IgAN). The main secondary objective of the study is to evaluate the efficacy of felzartamab compared to placebo on kidney functions in participants with IgAN. The additional secondary objectives are to evaluate the efficacy of felzartamab compared to placebo on additional clinical endpoints and to assess the pharmacokinetics (PK) and immunogenicity of felzartamab