Visionary Study: Phase 3 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy (IgAN)
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|ClinicalTrials.gov Identifier: NCT05248646|
Recruitment Status : Recruiting
First Posted : February 21, 2022
Last Update Posted : March 10, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Immunoglobulin A Nephropathy||Drug: Sibeprenlimab 400 mg Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||470 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects With Immunoglobulin A Nephropathy.|
|Actual Study Start Date :||March 15, 2022|
|Estimated Primary Completion Date :||December 30, 2026|
|Estimated Study Completion Date :||December 30, 2026|
|Active Comparator: Sibeprenlimab 400 mg s.c. q 4weeks||
Drug: Sibeprenlimab 400 mg
Sibeprenlimab 400 mg s.c. q 4 weeks
Other Name: VIS649
|Placebo Comparator: Placebo||
Placebo s.c. q 4 weeks
- Urinary protein to creatinine ratio (uPCR) in a 24-hour collection [ Time Frame: At 9 months ]
- Annualized rate of change from baseline (slope) of eGFR [ Time Frame: Over 24 months ]
- Proportion of subjects achieving urine total protein < 1.0 g/day and ≥ 25% reduction from baseline. [ Time Frame: At 12 months ]
- Annualized slope of eGFR [ Time Frame: Over 12 months ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Male and female patients ≥ 18 years of age .
- Biopsy-confirmed IgAN. (Patients with an eGFR of 30 to 45 mL/min/1.73m2 must have had a kidney biopsy performed within 36 months of the screening visit).
- Stable and maximally tolerated dose of ACEI and/or ARB for at least 3 months prior to screening. Patients who are on a stable dose of SGLT2i may participate if treatment was initiated ≥3 months prior to screening. Patients who are unable to take an ACEI or ARB may participate if their overall management conforms with standards of care and other protocol requirements.
- Screening urine protein/creatinine ratio (uPCR) ≥ 0.75 g/g or urine protein ≥ 1.0 g/day
- eGFR ≥ 30 mL/min/1.73 m2, (for the exploratory cohort only: eGFR 20- <30 mL/min/1.73 m2), calculated using the CKD-EPI equation.)
- Secondary forms of IgAN or IgA vasculitis.
- Coexisting chronic kidney disease other than IgAN.
- Kidney biopsy findings in addition to IgAN including those of diabetic nephropathy, membranous nephropathy, or lupus nephritis. Hypertensive vascular changes are acceptable.
- Kidney biopsy MEST or MEST-C score of T2 or C2 (Oxford IgAN classification). If MEST-scoring was not performed, the presence of > 50% tubulo-interstitial fibrosis, or crescents in > 25% of glomeruli is exclusionary. This does not apply to the exploratory cohort.
- Nephrotic syndrome
- Serum IgG < 600 mg/dL at screening.
- Chronic systemic immunosuppression, including glucocorticoids, within 16 weeks of randomization
- Participation in another interventional clinical trial and receipt of another investigational drug within 30 days prior to the administration of IMP or 5 half-lives from last investigational drug administration, whichever is longer.
- Chronic infectious disease, or acute infectious disease at time of screening.
- Type 1 diabetes, or poorly controlled Type 2 diabetes
- Uncontrolled hypertension
The protocol provides additional information about these and other inclusion and exclusion criteria.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05248646
|Contact: Otsuka Call Center||844-687-8522||OtsukaUS@druginfo.com|
|United States, New York|
|For additional information regarding sites, contact 844-687-8522||Recruiting|
|New York, New York, United States, 10001|
|Responsible Party:||Otsuka Pharmaceutical Development & Commercialization, Inc.|
|Other Study ID Numbers:||
|First Posted:||February 21, 2022 Key Record Dates|
|Last Update Posted:||March 10, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.|
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
|Time Frame:||Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.|
|Access Criteria:||Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
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