Evidence map›Paper›PMID 37916620›Full record

Trial reportThe New England journal of medicine2024

A Phase 2 Trial of Sibeprenlimab in Patients with IgA Nephropathy.

Mohit Mathur, Jonathan Barratt, Bobby Chacko, Tak Mao Chan, Laura Kooienga, Kook-Hwan Oh, Manisha Sahay, Yusuke Suzuki, Muh Geot Wong, Jill Yarbrough and 3 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The New England journal of medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04287985 (A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy and Safety of VIS649 in Participants With Immunoglobulin A), which is not on this map. Cited by 134 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
134citing papers in PubMed, 9 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04287985 phase2completednot on this map

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy and Safety of VIS649 in Participants With Immunoglobulin A (IgA) Nephropathy

TypeinterventionalSponsorOtsuka Pharmaceutical Development & Commercialization, Inc.Ran2020 to 2023Enrolled155ConditionsImmunoglobulin A Nephropathy, Glomerular Disease, IgANArmsDose-Placebo, Low Dose-VIS649, Medium Dose-VIS649, High Dose-VIS649
3 · Its place in the literature

Who cites it

134 citing papers in PubMed, 9 syntheses or guidelines pooled it.

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  9. Immunosuppressive therapy for IgA nephropathy in children.The Cochrane database of systematic reviews · 2024
    Pooled it
  10. Trial
  11. Review
  12. APRIL: spring forward also for IgA vasculitis nephritis in children.Pediatric nephrology (Berlin, Germany) · 2026
    Article
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74 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors.

Mohit MathurFrom Visterra, Waltham, MA (M.M., J.Y., B.J.G.P.); John Walls Renal Unit, Leicester General Hospital, Leicester, United Kingdom (J.B.); Nephrology and Transplantation, John Hunter Hospital and University of Newcastle, Newcastle, NSW (B.C.), and the University of Sydney, Sydney (M.G.W.) - both in Australia; the University of Hong Kong, Queen Mary Hospital, Hong Kong (T.M.C.); Colorado Kidney Care, Denver (L.K.); Seoul National University College of Medicine, Seoul, South Korea (K.-H.O.); Osmania General Hospital, Hyderabad, India (M.S.); the Department of Nephrology, Juntendo University Faculty of Medicine, Tokyo (Y.S.); and Otsuka Pharmaceutical Development and Commercialization, Princeton, NJ (J.X.).
Jonathan BarrattFrom Visterra, Waltham, MA (M.M., J.Y., B.J.G.P.); John Walls Renal Unit, Leicester General Hospital, Leicester, United Kingdom (J.B.); Nephrology and Transplantation, John Hunter Hospital and University of Newcastle, Newcastle, NSW (B.C.), and the University of Sydney, Sydney (M.G.W.) - both in Australia; the University of Hong Kong, Queen Mary Hospital, Hong Kong (T.M.C.); Colorado Kidney Care, Denver (L.K.); Seoul National University College of Medicine, Seoul, South Korea (K.-H.O.); Osmania General Hospital, Hyderabad, India (M.S.); the Department of Nephrology, Juntendo University Faculty of Medicine, Tokyo (Y.S.); and Otsuka Pharmaceutical Development and Commercialization, Princeton, NJ (J.X.).
Bobby ChackoFrom Visterra, Waltham, MA (M.M., J.Y., B.J.G.P.); John Walls Renal Unit, Leicester General Hospital, Leicester, United Kingdom (J.B.); Nephrology and Transplantation, John Hunter Hospital and University of Newcastle, Newcastle, NSW (B.C.), and the University of Sydney, Sydney (M.G.W.) - both in Australia; the University of Hong Kong, Queen Mary Hospital, Hong Kong (T.M.C.); Colorado Kidney Care, Denver (L.K.); Seoul National University College of Medicine, Seoul, South Korea (K.-H.O.); Osmania General Hospital, Hyderabad, India (M.S.); the Department of Nephrology, Juntendo University Faculty of Medicine, Tokyo (Y.S.); and Otsuka Pharmaceutical Development and Commercialization, Princeton, NJ (J.X.).
Tak Mao ChanFrom Visterra, Waltham, MA (M.M., J.Y., B.J.G.P.); John Walls Renal Unit, Leicester General Hospital, Leicester, United Kingdom (J.B.); Nephrology and Transplantation, John Hunter Hospital and University of Newcastle, Newcastle, NSW (B.C.), and the University of Sydney, Sydney (M.G.W.) - both in Australia; the University of Hong Kong, Queen Mary Hospital, Hong Kong (T.M.C.); Colorado Kidney Care, Denver (L.K.); Seoul National University College of Medicine, Seoul, South Korea (K.-H.O.); Osmania General Hospital, Hyderabad, India (M.S.); the Department of Nephrology, Juntendo University Faculty of Medicine, Tokyo (Y.S.); and Otsuka Pharmaceutical Development and Commercialization, Princeton, NJ (J.X.).
Laura KooiengaFrom Visterra, Waltham, MA (M.M., J.Y., B.J.G.P.); John Walls Renal Unit, Leicester General Hospital, Leicester, United Kingdom (J.B.); Nephrology and Transplantation, John Hunter Hospital and University of Newcastle, Newcastle, NSW (B.C.), and the University of Sydney, Sydney (M.G.W.) - both in Australia; the University of Hong Kong, Queen Mary Hospital, Hong Kong (T.M.C.); Colorado Kidney Care, Denver (L.K.); Seoul National University College of Medicine, Seoul, South Korea (K.-H.O.); Osmania General Hospital, Hyderabad, India (M.S.); the Department of Nephrology, Juntendo University Faculty of Medicine, Tokyo (Y.S.); and Otsuka Pharmaceutical Development and Commercialization, Princeton, NJ (J.X.).
Kook-Hwan OhFrom Visterra, Waltham, MA (M.M., J.Y., B.J.G.P.); John Walls Renal Unit, Leicester General Hospital, Leicester, United Kingdom (J.B.); Nephrology and Transplantation, John Hunter Hospital and University of Newcastle, Newcastle, NSW (B.C.), and the University of Sydney, Sydney (M.G.W.) - both in Australia; the University of Hong Kong, Queen Mary Hospital, Hong Kong (T.M.C.); Colorado Kidney Care, Denver (L.K.); Seoul National University College of Medicine, Seoul, South Korea (K.-H.O.); Osmania General Hospital, Hyderabad, India (M.S.); the Department of Nephrology, Juntendo University Faculty of Medicine, Tokyo (Y.S.); and Otsuka Pharmaceutical Development and Commercialization, Princeton, NJ (J.X.).
Manisha SahayFrom Visterra, Waltham, MA (M.M., J.Y., B.J.G.P.); John Walls Renal Unit, Leicester General Hospital, Leicester, United Kingdom (J.B.); Nephrology and Transplantation, John Hunter Hospital and University of Newcastle, Newcastle, NSW (B.C.), and the University of Sydney, Sydney (M.G.W.) - both in Australia; the University of Hong Kong, Queen Mary Hospital, Hong Kong (T.M.C.); Colorado Kidney Care, Denver (L.K.); Seoul National University College of Medicine, Seoul, South Korea (K.-H.O.); Osmania General Hospital, Hyderabad, India (M.S.); the Department of Nephrology, Juntendo University Faculty of Medicine, Tokyo (Y.S.); and Otsuka Pharmaceutical Development and Commercialization, Princeton, NJ (J.X.).
Yusuke SuzukiFrom Visterra, Waltham, MA (M.M., J.Y., B.J.G.P.); John Walls Renal Unit, Leicester General Hospital, Leicester, United Kingdom (J.B.); Nephrology and Transplantation, John Hunter Hospital and University of Newcastle, Newcastle, NSW (B.C.), and the University of Sydney, Sydney (M.G.W.) - both in Australia; the University of Hong Kong, Queen Mary Hospital, Hong Kong (T.M.C.); Colorado Kidney Care, Denver (L.K.); Seoul National University College of Medicine, Seoul, South Korea (K.-H.O.); Osmania General Hospital, Hyderabad, India (M.S.); the Department of Nephrology, Juntendo University Faculty of Medicine, Tokyo (Y.S.); and Otsuka Pharmaceutical Development and Commercialization, Princeton, NJ (J.X.).
Muh Geot WongFrom Visterra, Waltham, MA (M.M., J.Y., B.J.G.P.); John Walls Renal Unit, Leicester General Hospital, Leicester, United Kingdom (J.B.); Nephrology and Transplantation, John Hunter Hospital and University of Newcastle, Newcastle, NSW (B.C.), and the University of Sydney, Sydney (M.G.W.) - both in Australia; the University of Hong Kong, Queen Mary Hospital, Hong Kong (T.M.C.); Colorado Kidney Care, Denver (L.K.); Seoul National University College of Medicine, Seoul, South Korea (K.-H.O.); Osmania General Hospital, Hyderabad, India (M.S.); the Department of Nephrology, Juntendo University Faculty of Medicine, Tokyo (Y.S.); and Otsuka Pharmaceutical Development and Commercialization, Princeton, NJ (J.X.).
Jill YarbroughFrom Visterra, Waltham, MA (M.M., J.Y., B.J.G.P.); John Walls Renal Unit, Leicester General Hospital, Leicester, United Kingdom (J.B.); Nephrology and Transplantation, John Hunter Hospital and University of Newcastle, Newcastle, NSW (B.C.), and the University of Sydney, Sydney (M.G.W.) - both in Australia; the University of Hong Kong, Queen Mary Hospital, Hong Kong (T.M.C.); Colorado Kidney Care, Denver (L.K.); Seoul National University College of Medicine, Seoul, South Korea (K.-H.O.); Osmania General Hospital, Hyderabad, India (M.S.); the Department of Nephrology, Juntendo University Faculty of Medicine, Tokyo (Y.S.); and Otsuka Pharmaceutical Development and Commercialization, Princeton, NJ (J.X.).
Jing XiaFrom Visterra, Waltham, MA (M.M., J.Y., B.J.G.P.); John Walls Renal Unit, Leicester General Hospital, Leicester, United Kingdom (J.B.); Nephrology and Transplantation, John Hunter Hospital and University of Newcastle, Newcastle, NSW (B.C.), and the University of Sydney, Sydney (M.G.W.) - both in Australia; the University of Hong Kong, Queen Mary Hospital, Hong Kong (T.M.C.); Colorado Kidney Care, Denver (L.K.); Seoul National University College of Medicine, Seoul, South Korea (K.-H.O.); Osmania General Hospital, Hyderabad, India (M.S.); the Department of Nephrology, Juntendo University Faculty of Medicine, Tokyo (Y.S.); and Otsuka Pharmaceutical Development and Commercialization, Princeton, NJ (J.X.).
Brian J G PereiraFrom Visterra, Waltham, MA (M.M., J.Y., B.J.G.P.); John Walls Renal Unit, Leicester General Hospital, Leicester, United Kingdom (J.B.); Nephrology and Transplantation, John Hunter Hospital and University of Newcastle, Newcastle, NSW (B.C.), and the University of Sydney, Sydney (M.G.W.) - both in Australia; the University of Hong Kong, Queen Mary Hospital, Hong Kong (T.M.C.); Colorado Kidney Care, Denver (L.K.); Seoul National University College of Medicine, Seoul, South Korea (K.-H.O.); Osmania General Hospital, Hyderabad, India (M.S.); the Department of Nephrology, Juntendo University Faculty of Medicine, Tokyo (Y.S.); and Otsuka Pharmaceutical Development and Commercialization, Princeton, NJ (J.X.).
ENVISION Trial Investigators Group

Funding

DBT-Wellcome Trust India Alliance IA/CPHS/22/1/506541
6 · The paper itself

Abstract

backgroundA proliferation-inducing ligand (APRIL) is implicated in the pathogenesis of IgA nephropathy. Sibeprenlimab is a humanized IgG2 monoclonal antibody that binds to and neutralizes APRIL.

methodsIn this phase 2, multicenter, double-blind, randomized, placebo-controlled, parallel-group trial, we randomly assigned adults with biopsy-confirmed IgA nephropathy who were at high risk for disease progression, despite having received standard-care treatment, in a 1:1:1:1 ratio to receive intravenous sibeprenlimab at a dose of 2, 4, or 8 mg per kilogram of body weight or placebo once monthly for 12 months. The primary end point was the change from baseline in the log-transformed 24-hour urinary protein-to-creatinine ratio at month 12. Secondary end points included the change from baseline in the estimated glomerular filtration rate (eGFR) at month 12. Safety was also assessed.

resultsAmong 155 patients who underwent randomization, 38 received sibeprenlimab at a dose of 2 mg per kilogram, 41 received sibeprenlimab at a dose of 4 mg per kilogram, 38 received sibeprenlimab at a dose of 8 mg per kilogram, and 38 received placebo. At 12 months, the geometric mean ratio reduction (±SE) from baseline in the 24-hour urinary protein-to-creatinine ratio was 47.2±8.2%, 58.8±6.1%, 62.0±5.7%, and 20.0±12.6% in the sibeprenlimab 2-mg, 4-mg, and 8-mg groups and the placebo group, respectively. At 12 months, the least-squares mean (±SE) change from baseline in eGFR was -2.7±1.8, 0.2±1.7, -1.5±1.8, and -7.4±1.8 ml per minute per 1.73 m

conclusionsIn patients with IgA nephropathy, 12 months of treatment with sibeprenlimab resulted in a significantly greater decrease in proteinuria than placebo. (Funded by Visterra; ENVISION ClinicalTrials.gov number, NCT04287985; EudraCT number, 2019-002531-29.).

Indexed as

Antibodies, Monoclonal, HumanizedGlomerulonephritis, IGATumor Necrosis Factor Ligand Superfamily Member 13Administration, IntravenousAdultCreatinineDouble-Blind MethodGlomerular Filtration RateHumansImmunoglobulin GProteinuriaAntibodies, Monoclonal, HumanizedCreatinineImmunoglobulin GTNFSF13 protein, humanTumor Necrosis Factor Ligand Superfamily Member 13

Identifiers

PMID37916620
PMCPMC7615905

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.