CTRI/2024/02/062883 [Registered on: 20/02/2024] Trial Registered Prospectively
Last Modified On:
27/01/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Non-randomized, Active Controlled Trial
Public Title of Study
Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy
Scientific Title of Study
A Phase 2/3, Multicenter, Open-label Trial to Evaluate the Long-term Safety,
Tolerability, and Efficacy of Sibeprenlimab Administered Subcutaneously in Subjects
with Immunoglobulin A Nephropathy
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Designation
Affiliation
Address
Phone
Fax
Email
Details of Contact Person Scientific Query
Name
Abby Abraham
Designation
Global Head Data Science & Country Head, India
Affiliation
George Clinical India Private Ltd
Address
George Clinical India Private Ltd, Plot No 5, 12th Floor Prestige Khoday Towers, Raj Bhavan Road, Bangalore 560001 Karnataka, India
Bangalore KARNATAKA 560001 India
Phone
919768962917
Fax
918049421426
Email
aabraham@georgeclinical.com
Details of Contact Person Public Query
Name
Abby Abraham
Designation
Global Head Data Science & Country Head, India
Affiliation
George Clinical India Private Ltd
Address
George Clinical India Private Ltd, Plot No 5, 12th Floor Prestige Khoday Towers, Raj Bhavan Road, Bangalore 560001 Karnataka, India
Bangalore KARNATAKA 560001 India
Phone
919768962917
Fax
918049421426
Email
aabraham@georgeclinical.com
Source of Monetary or Material Support
Department of Nephrology, Ground Floor, C-Block, Nehru Hospital, Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh, Sector-12, 160012
Dept. of Nephrology, Christian Medical College Vellore Ranipet Campus, 6th Floor A Block, Kilminnal Village, Ranipet District-632517
Dept. of Nephrology, Govt. Medical College, Calicult, Kerala-673008, India
Government Medical College, Department of Nephrology, Super Speciality Building, Ulloor Road, Thiruvananthapuram, Kerala - 695011, India
Government Stanley Medical College and Hospital, No. 1, Old Jail Rd, Chennai-600001, Tamil nadu, India
Jawaharlal Institute of Postgraduate Medical Education & Research, JIPMER Dhanvantari Nagar, Puducherry -605006
Kasturba Medical college and Hospital, Udupi -Hebri Rd, Madhav Nagar, Manipal -576104, Karnataka, India
KD Hospital, Vaishnodevi Circle, SG Highway, Ahmedabad, Gujarat -382421, India
Lifepoint Multispecialty Hospital, 145/1, Mumbai Bangalore Highway, near Sayaji Hotel, Wakad, Pune -411057, Maharashtra, India
Mahatma Gandhi Mission, MGM Medical College and Hospital, N-6 Cidco, Aurangabad -431003, Maharashtra -India
Mazumdar Shaw Medical Center-a unit of Narayana Health No.258/A, Bommasandra Industrial Area, Anekal Taluk, Bengaluru, Karnataka-560099, India
MS Ramaiah Medical College & Hospital, M S Ramaiah Nagar, MSRIT, Bengaluru, Karnataka-560054, India
Muljibhai Patel Urological Hospital, Dr. Virendra Desai Road, Nadiad, Gujarat -387001, India
Nizam’s Institute of Medical Sciences, Panjagutta Rd, Panjagutta, Hyderabad, Telangana-500082, India
Osmania General Hospital, Afzalgunj Hyderabad, India-500012
Otsuka Pharmaceutical Development & Commercialization, Inc.
2440 Research Boulevard
Rockville, Maryland 20850, United States
Sanjay Gandhi Post graduate institute of Medical Sciences, Raebareli road, Lucknow -226014
Sir Ganga Ram Hospital, Old Rajinder Nagar, New Delhi-110060, India
Primary Sponsor
Name
Otsuka Pharmaceutical Development Commercialization Inc
Address
2440 Research Boulevard
Rockville, Maryland 20850, United States
Argentina Australia Belgium Brazil Canada China Croatia Czech Republic France Germany Greece Hong Kong Hungary India Israel Italy Japan Malaysia Netherlands Philippines Poland Portugal Republic of Korea Singapore Spain Sri Lanka Taiwan Thailand United Kingdom United States of America
Christian Medical College Vellore Ranipet Campus, Department of Nephrology, A Block, 6th Floor, Kilminnal
Village, Ranipet district,
Ranipet - 632517, Tamil
NÄdu, India Vellore TAMIL NADU
9894519136
suceena@gmail.com
Dr Gracious Noble
Government Medical College, Ulloor
Research Room, Ground Floor, Department of Nephrology, Super Specialty Block,
Government Medical College, Ulloor, Akkulam Rd, near SAT Hospital Medical College Junction, Chalakkuzhi, Thiruvananthapuram,
Kerala, 695011 Thiruvananthapuram KERALA
04712528386
noblegracious@hotmail.com
Dr PriyamVada
Jawaharlal Institute of Postgraduate Medical Education and Research
Room No. 6 (OPD no. 308), 2nd Floor, Department of Nephrology, Super Specialty Block,
The Jawaharlal Institute of Postgraduate Medical Education & Research,
Jipmer Campus Rd, Gorimedu, Priyadarshini Nagar, Puducherry, 605006 Pondicherry PONDICHERRY
7598566984
priyamvadaps@gmaill.com
Dr Prabhu Attur Ravindra
Kasturba Medical college and Hospital
Clinical Research Room, 1st Floor, Kasturba Medical College and Hospital, Administrative Building,
Kasturba Medical College and Hospital,
Udupi-Hebri Rd, Madhav Nagar, Manipal, 576104, Karnataka Udupi KARNATAKA
9448107771
aravindraPrabhu@gmail.com
Dr Biju K Gopinath
Kerala University of Health Sciences Government Medical College
Department of Nephrology, Super Specialty Block, Govt. Medical College Calicut, Kerala, 673008 Kozhikode KERALA
919447167698
bijukgopinath@me.com
Dr Jay Patel
Kusum Dhirajlal Hospital
Clinical Research Room, 4th Floor, Clinical Research Department, Main Building,
Kusum Dhirajlal Hospital,
Vaishnodevi Circle, SG Highway, Ahmedabad, Gujarat 382421 Ahmadabad GUJARAT
9909994536
dr.jaykumarpatel@kdhospital.co.in
Dr Tarun Jeloka
Lifepoint Multispecialty Hospital
3rd Floor, Clinical research Department, Lifepoint Multispecialty Hospital,
145/1, Mumbai-Bangalore Highway,
near Sayaji Hotel,
Wakad, Pune 411057,
Maharashtra Pune MAHARASHTRA
020-66434366
tarun.jeloka@gmail.com
Dr Sudhir Kukarni
Mahatma Gandhi Mission, MGM Medical College and Hospital
Clinical Research Center, 4th Floor, Department of Pharmacology,
Mahatma Gandhi Mission, MGM Medical College and Hospital,
N-6 Cidco, Aurangabad 431003,
Maharashtra Aurangabad MAHARASHTRA
9422713691
sudhirkul1979@gmail.com
Dr KC Gurudev
MS Ramaiah Medical College Hospital
Clinical Research Room, 1st Floor, Advance Learning Centre Building, M S Ramiah Medical College and Hospital,
M S Ramaiah Nagar, MSRIT,
Bengaluru, Karnataka 560054
Bangalore KARNATAKA
9900165961
gurudevkc@gmail.com
Dr Umapati Hegde
Muljibhai Patel Urological Hospital
1 and 2 Clinical Research Room, 2nd Floor, Main Building, Department of Nephrology,
Muljibhai Patel Urological Hospital,
Dr. Virendra Desai Road,
Nadiad, Gujarat, 387001 Kheda GUJARAT
9426043141
umapatih@gmail.com
Dr Limesh Marisiddappa
Narayana Health Hospital Health City
Room Number 35, Ground Floor, Department of Nephrology and Renal Transplant, A Block,
Mazumdar Shaw Medical Center, a unit of Narayana Health Institution,
No.258/A, Bommasandra Industrial Area,
Hosur Road, Anekal Taluk,
Bengaluru, Karnataka 560099 Bangalore KARNATAKA
96638890983
limijay_2007@yahoo.co.in
Dr Raju Sree Bhushan
Nizams Institute of Medical Sciences
Room 229, 2nd Floor, Department of Nephrology, Millanium Block, New OPD Building,
Nizams Institute of Medical Sciences,
Punjagutta Rd, Punjagutta Market,
Punjagutta, Hyderabad, Telangana 500082 Hyderabad TELANGANA
04023489000
sreebhushan@hotmail.com
Dr Manisha Sahay
Osmania Hospital
QQCD Building, 3rd Floor,
Department of Nephrology, Osmania General Hospital,
Afzalgunj, Hyderabad -
500012, Telangana, India Hyderabad TELANGANA
9849097507
drmanishasahay@gmail.com
Dr Ramachandran Raja
Post Graduate Institute of Medical Education & Research (PGIMER)
Department of Nephrology, Ground floor, C-block, Nehru
hospital, Sector-12,
Chandigarh - 160012,
Punjab, India Chandigarh CHANDIGARH
9216958874
drraja_1980@yahoo.co.in
Dr Prasad Narayan
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Research Room, 2nd Floor, Department of Nephrology, C Block, Old OPD,
Sanjay Gandhi post graduate institute of
Medical Sciences,
Department of Nephrology & Renal Transplant, Raebareli road, Lucknow, 226014,
Uttar Pradesh Lucknow UTTAR PRADESH
9415403140
narayan.nephro@gmail.com
Dr Bhalla Anil Kumar
Sir Ganga Ram Hospital
Research Room, 2nd Floor, Dialysis Unit, Old Admission Block, Old OPD Building, Old Rajinder Nagar, New Delhi 110060 New Delhi DELHI
Human Ethics Committee Medical College, Thiruvananthapuram (074)
Approved
Institutional Ethics Committee Government Medical College, Kozhikode (071)
Approved
Institutional Ethics Committee of PGIMER (077)
Approved
Institutional Ethics Committee Osmania Medical College (078)
Approved
Institutional Ethics Committee, SGPGIMS (076)
Approved
Institutional Review Board, Christian Medical College (080)
Approved
JIPMER Institute Ethics Committee (085)
Submittted/Under Review
KD Hospital Institutional Ethics Committee (073)
Submittted/Under Review
LPR Ethics Committee (084)
Submittted/Under Review
M S Ramaiah Medical College & Hospital (072)
Submittted/Under Review
Mahatma Gandhi Missions Ethics Committee (082)
Submittted/Under Review
MAHE Ethics Committee (079)
Approved
Muljibhai Patel Society for Research in Nephro-Urology Ethics Committee (070)
Submittted/Under Review
Narayana Health Medical Ethics Committee (087)
Approved
NIMS Institutional Ethics Committee (081)
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Not applicable
Not applicable
Intervention
Sibeprenlimab (VIS649)
This trial will evaluate a dose of 400 mg sibeprenlimab. Sibeprenlimab will be administered as a SC injection once every 4 weeks. A total of
26 doses are planned to be administered, with Dose 1 administered on Day 1 and Dose 26 administered in Week 100.
Subjects are required to meet the following inclusion criteria when assessed:
1) Subjects who completed Trial 417-201-00007 (at least 20 of the 26 doses and the end-of-trial visit) or Trial VIS649-201 (at least 9 of the 12 doses and the end-of-trial visit) without safety concerns and who, in the opinion of the investigator, could potentially benefit from treatment with sibeprenlimab for IgAN.
2) Subject has eGFR more than or equal to 20 mL/min/1.73 m2, calculated using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine eGFR formula.
3) Ability to provide written, informed consent prior to initiation of any trial-specific procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial.
ExclusionCriteria
Details
1) Subjects who have not completed participation in Trials 417-201-00007 or VIS649-201.
2) Subjects with treatment-limiting adverse events (AEs) during Trials 417-201-00007 or VIS649-201 considered related to IMP per investigator judgement.
3) Noncompliance, due to subject`s repeated failure to follow trial procedures during the course of their participation in Trials 417-201-00007 and VIS649-201 (eg, subjects deemed to be noncompliant with the visit schedule, trial assessments, or treatment regimen). The medical monitor should be contacted if the investigator is unsure of a subject`s eligibility.
4) Subjects who have a positive pregnancy test result prior to receiving IMP.
5) Heterosexually active biological males or subjects of childbearing potential, or their partners, who do not agree to adhere to contraceptive requirements from the time of consent through the end of the subject`s participation in the trial and an additional 90 days (biological male subjects) or 30 days (biological female subjects) thereafter.
6) Subjects must also agree not to donate sperm from the time of consent through the end of the subject`s participation in the trial and an additional 90 days thereafter.
7) Subject has nephrotic syndrome, defined for this purpose as 24-hour urine protein > 3.5 g with concurrent hypoalbuminemia (serum albumin < 2.5 g/dL), hyperlipidemia (total cholesterol > 350 mg/dL), and edema. Subjects with isolated nephrotic range proteinuria (> 3.5 g/day) will be eligible.
8) Subject has a history or current evidence of a serious and/or unstable cardiovascular, respiratory, gastrointestinal, hematologic, autoimmune, rheumatologic, blood dyscrasias or other medical disorder, including psychiatric
disorders, cirrhosis, or ongoing malignancy. History of minor skin cancers (not
including melanoma) or surgically treated, limited cervical carcinomas (ie, carcinoma in situ) are not exclusionary.
9) History of a previous severe allergic reaction with generalized urticaria; angioedema or anaphylaxis.
10) Subject has a body mass index < 16 kg/m2.
11) Subject has received an organ transplant (ie, solid or a bone marrow or hematologic stem cell transplantation).
12) Subject is currently receiving, or has received within 16 weeks prior to enrollment, systemic immunosuppression (note: topical, ophthalmic, rectal, intra-articular, inhaled corticosteroids, and short courses of oral/intravenous steroids [less than or equal to 14 days] are allowed).
13) Subject has participated in another interventional clinical trial (other than Trials 417-201-00007 and VIS649-201) and received another investigational drug within 30 days prior to the administration of IMP or 5 half-lives from last investigational drug administration, whichever is longer.
14) Subject has any chronic infectious disease (eg, chronic urinary tract infection; chronic sinusitis; bronchiectasis; active pulmonary or systemic tuberculosis; chronic viral hepatitis, such as hepatitis C or hepatitis B [defined as positive for hepatitis B surface antigen]; or human immunodeficiency virus [HIV] infection).
15) Subject has acute infectious disease at the time of screening.
16) Subject has Type 1 diabetes.
17) Subject has uncontrolled Type 2 diabetes, as evidenced by a screening hemoglobin A1c (HbA1c) value > 8%.
18) Subject has uncontrolled hypertension (defined as systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg).
19) Subject who has a history of alcohol or drug/chemical abuse based on the investigator`s clinical judgement.
20) Subject is judged by the investigator or the medical monitor to be inappropriate for the trial.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To evaluate the long-term safety and tolerability of sibeprenlimab in subjects with IgAN.
From baseline to the end-of-trial visit in Week 112.
Secondary Outcome
Outcome
TimePoints
Annualized slope of Estimated Glomerular Filtration Rate(eGFR)
Over 12 & 24 months
Urine protein-creatinine ratio (uPCR) in a 24-hour collection
At 12 & 24 months
Proportion of Subjects with Clinical Remission as defined in the protocol
At 12 & 24 months
Time to Progression of Chronic Kidney Disease, as defined in the protocol
Over 24 months
Target Sample Size
Total Sample Size="600" Sample Size from India="46" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
This is a phase 2/3, multicenter, open-label trial to evaluate the long-term safety, tolerability, and efficacy of sibeprenlimab administered subcutaneously (SC) to subjects with IgAN.
The screening visit will take place at the trial site clinic up to 30 days prior to the first dose of investigational medicinal product (IMP). Where possible, it is recommended that assessments collected after completion of IMP administration in Trials 417-201-00007 or VIS649-201 be utilized for screening. If the 24-hour urine collection was performed within the past 3 months prior to screening, the collection does not need to be repeated at screening.
Eligible subjects will attend the screening and Day 1 visit at the trial site clinic. All other visits may be completed remotely using mobile health services per the discretion of the investigator and subject.
Sibeprenlimab will be administered as a SC injection once every 4 weeks. A total of 26 doses are planned to be administered, with Dose 1 administered on Day 1 and Dose 26 administered in Week 100. Subjects discontinuing treatment prior to Dose 26 will complete the early discontinuation visit (assessments at Week 104) at the time of treatment discontinuation and will be encouraged to complete the remainder of all planned trial visits after treatment discontinuation.
Subjects will complete a follow-up visit in Week 104. The end-of-trial visit will take place in Week 112, at which time final assessments will be performed.
Subjects will be evaluated throughout the trial for safety, efficacy, pharmacodynamics (PD), pharmacokinetics (PK), and immunogenicity assessments.
Enrollment into the trial will be drawn from eligible subjects who, in the investigator’s judgement, could potentially benefit from treatment with sibeprenlimab for IgAN and will include rollover subjects from Trials 417-201-00007 and VIS649-201. Eligible subjects will include:
- Subjects who have completed at least 20 of the 26 doses and the end-of-trial visit in the phase 3, double-blind, placebo-controlled trial to evaluate the efficacy and safety of sibeprenlimab administered SC in subjects with IgAN (Trial 417-201-00007),
- Subjects who have completed at least 9 of the 12 doses and the end-of-trial visit in the phase 2, double-blind, placebo-controlled, multiple dose trial to evaluate the efficacy and safety of sibeprenlimab administered intravenously (IV) in subjects with IgAN (Trial VIS649-201).
De novo (new) subjects will not be enrolled in this trial.