| CTRI Number |
CTRI/2024/04/065305 [Registered on: 05/04/2024] Trial Registered Prospectively |
| Last Modified On: |
12/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study of BION-1301 in Adults with IgA Nephropathy. |
|
Scientific Title of Study
|
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of BION-1301 in Adults with IgA Nephropathy
(The BEYOND Study) |
| Trial Acronym |
The BEYOND Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2023-503743-34-00 |
EudraCT |
| CHK0202, Version 2.0 Amendment 1 dated 04 April 2023 |
Protocol Number |
| U1111-1290-6928 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rashmi Chitgupi |
| Designation |
Country Head- Clinical Management |
| Affiliation |
PPD Pharmaceutical Development India Private Limited |
| Address |
101-A Wing Fulcrum, Hiranandani Business Park, Sahar Road,
Andheri East 101-A Wing Fulcrum, Hiranandani Business Park,
Sahar Road, Andheri East
Mumbai
MAHARASHTRA
400099
India |
| Phone |
02266022900 |
| Fax |
|
| Email |
rashmi.chitgupi@ppd.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rashmi Chitgupi |
| Designation |
Country Head- Clinical Management |
| Affiliation |
PPD Pharmaceutical Development India Private Limited |
| Address |
101-A Wing Fulcrum, Hiranandani Business Park, Sahar Road,
Andheri East 101-A Wing Fulcrum, Hiranandani Business Park,
Sahar Road, Andheri East
Mumbai
MAHARASHTRA
400099
India |
| Phone |
02266022900 |
| Fax |
|
| Email |
rashmi.chitgupi@ppd.com |
|
Details of Contact Person
Public Query
|
| Name |
Rashmi Chitgupi |
| Designation |
Country Head- Clinical Management |
| Affiliation |
PPD Pharmaceutical Development India Private Limited |
| Address |
101-A Wing Fulcrum, Hiranandani Business Park, Sahar Road,
Andheri East 101-A Wing Fulcrum, Hiranandani Business Park,
Sahar Road, Andheri East
Mumbai
MAHARASHTRA
400099
India |
| Phone |
02266022900 |
| Fax |
|
| Email |
rashmi.chitgupi@ppd.com |
|
|
Source of Monetary or Material Support
|
| Chinook Therapeutics, Inc. |
|
|
Primary Sponsor
|
| Name |
Chinook Therapeutics, Inc. |
| Address |
400 Fairview Ave North, 9th Floor Seattle, WA 98109 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Argentina
Australia
Belgium
Brazil
Canada
China
Croatia
Czech Republic
France
Germany
Greece
India
Israel
Italy
Japan
Malaysia
Mexico
Republic of Korea
Spain
Taiwan
Turkey
United Kingdom
United States of America |
|
Sites of Study
|
| No of Sites = 12 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Urmila Anandh |
Amrita Institute of Medical Sciences and Research Centre |
UG floor, Research building, Mata Amritanandamayi Marg, RPS city, Sector 88, Faridabad Haryana -121002
Faridabad
HARYANA |
7093505100
uananda@gmail.com |
| Dr Suceena Alexander |
Christian Medical College |
Department of Nephrology, Unit-3, Vellore Tamil Nadu - 632517
Vellore
TAMIL NADU |
9894519136
suceena@gmail.com |
| Dr Ragi Krishnan G |
Government Medical College |
Ground floor, Research room, Department of Nephrology, Super speciality Block, Medical College PO Thiruvananthapuram
Kerala - 695011
Thiruvananthapuram
KERALA |
04712528548
drragiresearch@gmail.com |
| Dr Vivek Kute |
IKDRC & ITS |
Department of Nephrology, Third Floor, Civil Hospital, Asarwa-380016
Ahmadabad
GUJARAT |
7922685454
drvivekkute@rediffmail.com |
| Dr Sunil R |
Kempegowda Institute of Medical Sciences Hospital and Research Centre |
Block, 1st Floor, Clinical Research Room, next to
Dialysis Unit, Kempegowda
Institute of Medical Sciences
Hospital and Research Centre ,
K.R.Road,V.V Puram Bengalore
Karnataka - 560004
Bangalore
KARNATAKA |
9986633848
srnephro@gmail.com |
| Dr Jitendra Goswami |
Maharaja Agrasen Superspeciality Hospital |
Department of Nephrology, Basement, Research Department, Central Spine , Agrasen Aspatal Marg Sector 7, Vidhyadhar Nagar, Jaipur Rajasthan - 302039
Jaipur
RAJASTHAN |
9509791723
goswamidoc@gmail.com |
| Dr Pinaki Mukhopadhyay |
NRS Medical College And Hospital |
Department of Nephrology, 4th Floor Santinary building, NRS Medical College And Hospital, 138, A.J.C Bose Road Kolkata West Bengal - 700014
Kolkata
WEST BENGAL |
9231978078
drpinaki71@yahoo.com |
| Dr Raja Ramachandran |
Post Graduate Institute of Medical Education and Research |
Room No. 6006, IEC Office, 6th
Floor P N Chuttani Block
Chandigarh Chandigarh - 160012
Chandigarh
CHANDIGARH |
9216958874
drraja1980@gmail.com |
| Dr Deepak Dewan |
Regency Health Super Specialty Hospital |
Nephrology Department, Room number 10, Basement, Ring road, Tedhi Pulia, Khurram Nagar Lucknow Uttar Pradesh - 226022
Lucknow
UTTAR PRADESH |
9936507362
drdeepakdewan@rediffmail.com |
| Dr Vivek Ruhela |
Shri Mahant Indiresh Hospital |
Department of Nephrology, ground floor, Patel Nagar - Dehradun
Uttarakhand - 248001
Dehradun
UTTARANCHAL |
01356672400
vivekruhela@yahoo.com |
| Dr Dhananjai Agrawal |
SMS Superspeciality Hospital |
Department of Nephrology, 5th Floor, Room number 507, Attached to SMS Medical college,
Vivekanand Marg, C-Scheme
Jaipur Rajasthan - 302001
Jaipur
RAJASTHAN |
9414459790
dhananjaynephro@gmail.com |
| Dr Pen Metsa Vijay Varma |
Yashoda Hospitals |
Nephrology Department, OPD 1, First Floor, Room number 104, Raj Bhavan Road,Somajiguda Hyderabad, Telangana - 500082
Hyderabad
TELANGANA |
9611555888
vijay.varma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 12 |
| Name of Committee |
Approval Status |
| Ethics Committee, N.R.S. Medical College |
Submittted/Under Review |
| Human Ethics Committee |
Submittted/Under Review |
| IEC Maharaja Agrasen Superspeciality Hospital |
Approved |
| IKDRC-ITS Ethics Committee |
Submittted/Under Review |
| INSTITUATIONAL REVIEW BOARD (IRB) Christian Medical College |
Submittted/Under Review |
| Institute Ethics Committee, PGIMER |
Submittted/Under Review |
| Institutional Ethics Committee for ESIC Faridabad |
Submittted/Under Review |
| Institutional Ethics Committee Regency Hospital |
Approved |
| Institutional Ethics Committee SMS Medical College & Attached Hospital |
Submittted/Under Review |
| Institutional Ethics Committee, SMIH |
Submittted/Under Review |
| KIMS Institutional Ethics Committee |
Submittted/Under Review |
| Yashoda Academy of Medical Education and Research |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N028||Recurrent and persistent hematuriawith other morphologic changes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BION-1301 |
Type: Drug (monoclonal antibody)
Dosage Form: Solution for injection
Unit Dose Strength(s): 150 mg/mL
Route of Administration: Subcutaneous Injection
Presentation: PFS with NSD (PFS + NSD)
Duration of study drug administration: every two weeks for 104 weeks
|
| Comparator Agent |
Placebo |
Type: Not applicable (NA)
Dosage Form: Solution for injection
Unit Dose Strength(s): NA
Route of Administration: Subcutaneous Injection
Presentation: PFS with NSD (PFS + NSD)
Duration of study drug administration: every two weeks for 104 weeks
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female subjects aged more than or equal to 18 years at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures.
2. Biopsy-proven IgAN within the past 10 years that is not due to secondary causes. A pseudonymized copy of the report must be available for review. If biopsy report within 10 years is not available, re-biopsy may be permitted upon discussion with the Medical Monitor.
3. eGFR greater than or equal to 30 mL/min/1.73m2 at Screening based on the 2021 CKD-EPI equation (for the exploratory cohort only: eGFR of greater than or equal to 20 to less than 30 mL/min/1.73 m2).
4. Total urine protein greater than or equal to 1.0 g/day and UPCR greater than or equal to 0.7 g/g, as measured from an adequate 24hour urine collection at Screening by a central laboratory.
5. Stable on a maximally tolerated dose of ACEi/ARB for at least 12 weeks prior to Screening or intolerant to ACEi/ARB; may also be on a stable and well tolerated dose of SGLT2i and/or ERAs/MRAs for at least 12 weeks prior to Screening for the treatment of IgAN.
6. Body mass index (BMI) between 18 and 40 kg/m2.
7. Screening weight of at least 50 kg.
8. Men and women of childbearing potential must agree to follow protocol-specified contraception guidance from Screening through approximately 5 half-lives after the final dose of study drug. Provide written informed consent and be willing to comply with study visits and procedures.
|
|
| ExclusionCriteria |
| Details |
1. Secondary forms of IgAN as determined by the Investigator, in the setting of systemic disorders, infections, autoimmune disorders or neoplasias.
2. Diagnosis of IgA Vasculitis or current or history of nephrotic syndrome
3. Average blood pressure (BP) greater than 150/90 mm Hg (systolic/diastolic). Clinical suspicion of IgAN with rapidly progressive glomerulonephritis (RPGN) based on KDIGO guidelines (KDIGO, 2021)
4. Chronic Kidney Disease, either clinically suspected or based on biopsy, resulting from any condition or another glomerulopathy/podocytopathy other than IgAN.
5. History of Type 1 Diabetes.
6. Subjects with Type 2 diabetes are excluded if any of the following are present:
o Screening HbA1c of greater than 8%.
o Evidence of diabetic changes on kidney biopsy, performed for any reason.
o History of diabetic microvascular/macrovascular disease. Unstable anti-diabetic regimen
7. Prior exposure to any antibody directed against APRIL.
8. History of a previous severe allergic reaction including a history of severe hypersensitivity reaction to any monoclonal antibody.
9. Received an investigational new drug within 28 days or 5 half-lives, whichever is longer, prior to Screening.
10. Received systemic corticosteroid therapy including budesonide (Tarpeyo/Kinpeygo) for more than 14 days within 12 weeks prior to Screening.
11. Use of systemic immunosuppressant medications
12. Current severe infection requiring antimicrobials or history of recurrent, severe, infections as determined by the Investigator.
13. Positive serology test for HIV or hepatitis infection.
14. Received a live vaccination within 12 weeks prior to Screening or plan to have a live vaccination within 6 months after the last dose of study drug.
15. Pregnancy or breastfeeding or intent to become pregnant or to donate sperm during the study period and until 24 weeks after last dose.
16. Participation in another interventional trial with an investigational agent/device is prohibited during the course of this study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of BION-1301 versus placebo on proteinuria in adults with IgA nephropathy |
Change in proteinuria (UPCR) from Baseline to Week 40. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of BION-1301 versus placebo on eGFR |
Change from Baseline to Week 104 in eGFR. |
| To evaluate the effect of BION-1301 versus placebo on specific clinical composite endpoints during the study |
Percent of subjects meeting the composite endpoint of experiencing at least 1 of the following during the study:
• At least 30% reduction in eGFR sustained for at least 30 days
• eGFR less than 15 mL/min/1.73m2, sustained for at least 30 days
• Chronic dialysis, greater than or equal to 30 days
• Kidney transplantation
• All-cause mortality |
|
|
Target Sample Size
|
Total Sample Size="292"
Sample Size from India="20"
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)
|
15/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
27/07/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="5"
Days="7" |
|
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
|
Safety and Efficacy of BION-1301 in Adults with IgA Nephropathy. Approximately 272 patients with eGFR greater than or equal to 30 mL/min/1.73m2 and with biopsy-proven IgAN will be randomized to receive 600mg Q2W BION-1301 or a matched placebo for 104 weeks. An additional exploratory cohort, not included in the primary analysis, will be comprised of approximately 20 subjects (10 subjects per arm) with biopsy-confirmed IgAN and eGFR of greater than or equal to 20 to less than 30 mL/min/1.73 m2. The primary objective of the study is to evaluate the effect of BION-1301 versus placebo on proteinuria in adults with IgA nephropathy. Subjects will have assessments of safety and efficacy for 2.5 years (up to 134 weeks). To facilitate study participation over this time period, where allowed by local regulations, options for remote study visits using telemedicine and home health may be offered.
|