Safety and Efficacy Study of VIS649 for IgA Nephropathy

NCT04287985 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: VIS649-2012019-002531-29U1111-1263-1268
• Study Type: interventional
• Target: 155
• Locations: 15 countries
• Sites: 93

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of VIS649 in participants with immunoglobulin A (IgA) Nephropathy (IgAN)

Conditions

IgAN; Immunoglobulin A Nephropathy; Glomerular Disease

Keywords

VIS649; Kidney Diseases; Glomerulonephritis, IGA; Glomerulonephritis; Nephritis; Autoimmune Diseases; Immune System Diseases; Immunoglobulins; Antibodies; Immunoglobulin A; Immunologic Factors; Physiological Effects of Drugs; Proteinuria

Outcome Measures

Primary Outcomes (5)

• Number of Participants With Adverse Events Graded by Severity

  The number of participants who experienced adverse events, graded by maximum severity, are presented.

  Baseline to End of Study (16 months)

• Changes From Baseline in Clinical Laboratory Tests

  The number of participants who experience a shift from normal at baseline to Grade 3/4 (moderate/sever) at a postbaseline time point are presented.

  Baseline to End of Study (16 months)

• Clinically Meaningful Changes From Baseline in Vital Signs

  The number of participants who experienced clinically meaningful changes from baseline in vital signs (body mass index, diastolic blood pressure, height, heart rate, mean arterial pressure, respiratory rate, systolic blood pressure, temperature, and weight) are presented.

  Baseline to End of Study (16 months)

• Clinically Significant Physical Examinations

  Clinically significant physical examination findings are presented.

  Baseline to End of Study (16 months)

• Change From Baseline in uPCR: Month 12

  Natural Log 24-Hour uPCR (Schedule A Urine Collection) Change from Baseline at Month 12: mixed model with repeated measurements

  12 months

Secondary Outcomes (16)

• Change From Baseline in uPCR: Months 9 and 16

  Baseline to 9 months and 16 months (16 months total)

• Change in 24-hour Urine Protein Excretion: Months 12 and 16

  16 months

• Participants Achieving a Greater Than or Equal to 30% Decline From Baseline in uPCR at Months 9, 12, and 16

  Baseline to 9,12, and 16 months (16 months total)

• Participants in Each Group Achieving Clinical Remission

  Baseline to End of Study (16 months)

• Change From Baseline in eGFR at Months 9, 12, and 16

  Baseline to 12 and 16 months

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo, normal saline (0.9% NaCl) will be administered IV

Drug: Dose-Placebo

Low Dose - VIS649

EXPERIMENTAL

Low dose of VIS649 administered IV

Drug: Low Dose-VIS649

Medium Dose - VIS649

EXPERIMENTAL

Medium dose of VIS649 administered IV

Drug: Medium Dose-VIS649

High Dose - VIS649

EXPERIMENTAL

High dose of VIS649 administered IV

Drug: High Dose-VIS649

Interventions

Dose-Placebo DRUG

Unit Dose Strength - 0.9%.

Placebo

Low Dose-VIS649 DRUG

Dose Level = Low

Low Dose - VIS649

Medium Dose-VIS649 DRUG

Dose Level = Medium

Medium Dose - VIS649

High Dose-VIS649 DRUG

Dose Level = High

High Dose - VIS649

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are eligible to be included in the study only if all of the following criteria apply:
• Participant is a male or female ≥ 18 years of age at the time of signing the informed consent.
• Participant must have biopsy-confirmed IgAN.
• Participant has medical records showing they have been on stable and maximally tolerated doses of either ACEI or ARB, as per local SOC and applicable guidelines, for at least 3 months preceding screening. Participants should optimally be on at least 50% of the maximum recommended dose of these agents; however, if a participant is on their maximally tolerated dose (and this is \< 50% of the maximum recommended dose) and has been on this dose for at least 3 months, they may be enrolled. Participants who are unable to tolerate ACEI/ARB therapy may be eligible for participation in the study if their overall management of IgAN, including BP control, is as per local SOC and applicable guidelines.
• Participants must have screening uPCR ≥ 0.75 g/g measured from a 24-hour urine or 24-hour urine protein ≥ 1.0 g/d, as measured from 24-hour urine collection. The proteinuria should be assessed when the participant is considered to be in a steady state with no recent heavy exercise, fever, or other potential issues that could impact the result.
• Participants must have eGFR ≥ 45 mL/min/1.73 m² using the CKD-EPI formula.
• Participant's serum Ig values must meet specified criteria
• Female participants of childbearing potential must have a negative serum pregnancy test prior to the first dose.
• Participant is willing to adhere to contraceptive requirements.
• Participant or a legally authorized representative is able and is willing to give voluntary written informed consent

You may not qualify if:

• Participants are excluded from the study if they meet any of the following criteria:
• Participant has secondary forms of IgAN as defined by the treating physician.
• Participant has co-existing CKD, other than IgAN.
• Participant has evidence of additional pathological findings in the kidney biopsy (eg, diabetic kidney disease, membranous nephropathy, or lupus nephritis). However, hypertensive vascular changes are acceptable.
• Participant has kidney biopsy MEST or MEST-C score as defined in the protocol.
• Participant has nephrotic syndrome.
• Participant has received a solid organ transplant, including kidney.
• Participant has received bone marrow or hematologic stem cell transplantation.
• Participant is currently receiving systemic immunosuppression (excluding topical, ophthalmic, per rectum, or inhaled corticosteroids).
• Participant has received treatment with systemic corticosteroid therapy within 16 weeks of initial screening.
• Participant has received treatment with a systemic immunosuppressive agents within 16 weeks of initial screening.
• Participant has any chronic infectious disease.
• Participant has acute infectious disease at the time of screening.
• Participant has Type 1 diabetes.
• Participant has uncontrolled Type 2 diabetes, as evidenced by a screening hemoglobin A1c value \> 8%.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (93)

Visterra Investigational Site

Birmingham, Alabama, 35294, United States

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Visterra Investigational Site

Los Angeles, California, 90027, United States

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Visterra Investigational Site

Oxnard, California, 93036, United States

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Visterra Investigational Site

Palo Alto, California, 94305, United States

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Visterra Investigational Site

Stanford, California, 94305, United States

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Denver, Colorado, 80230, United States

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Lawrenceville, Georgia, 30046, United States

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Baton Rouge, Louisiana, 70808, United States

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Visterra Investigational Site

New Orleans, Louisiana, 70121, United States

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Baltimore, Maryland, 21201, United States

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Visterra Investigational Site

Tupelo, Mississippi, 38801, United States

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New York, New York, 10016, United States

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Chapel Hill, North Carolina, 27599, United States

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Columbus, Ohio, 43210, United States

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Bethlehem, Pennsylvania, 18017, United States

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Visterra Investigational Site

Houston, Texas, 77030, United States

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Visterra Investigational Site

Houston, Texas, 77054, United States

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New Lambton Heights, New South Wales, 2305, Australia

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Saint Leonards, New South Wales, 2065, Australia

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Nambour, Queensland, 4560, Australia

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Nedlands, Western Australia, 6009, Australia

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Calgary, Alberta, T2N 2T9, Canada

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Brampton, Ontario, L6R 3J7, Canada

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Montreal, Quebec, H4A 3J1, Canada

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Hong Kong, HK, Hong Kong

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Hong Kong, Hong Kong

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Kowloon, 999077, Hong Kong

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Visterra Investigational Site

Tsuen Wan, Hong Kong

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Chandigarh, Chandigarh, 160012, India

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Bangalore, Karnataka, 560054, India

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Bengaluru, Karnataka, 560034, India

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Manipal, Karnataka, 576104, India

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Kozhikode, Kerala, 673008, India

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Thiruvananthapuram, Kerala, 695011, India

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New Delhi, National Capital Territory of Delhi, 110060, India

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Vellore, Tamil Nadu, 632004, India

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Hyderabad, Telangana, 500012, India

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Hyderabad, Telangana, 500082, India

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Raebareli, Uttar Pradesh, 226014, India

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Toyoake-shi, Aichi-ken, 470-1192, Japan

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Tokyo, Nerima Ku, 177-8521, Japan

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Ashikaga, Tochigi, 326-0843, Japan

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Ashikaga-Shi, 326-0843, Japan

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Bunkyō City, 113-8431, Japan

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Kashihara-shi, 634-8522, Japan

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Minatoku, 470-1192, Japan

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Niigata, 951-8520, Japan

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Shinjuku-Ku, 162-8666, Japan

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Tsukuba, 305-876, Japan

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Urayasu-Shi, 279-0021, Japan

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Klang, 41200, Malaysia

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Kuala Lumpur, 56000, Malaysia

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Visterra Investigational Site

Kuala Lumpur, 59100, Malaysia

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Kuantan, 25100, Malaysia

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Seremban, 70300, Malaysia

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Diliman, 1101, Philippines

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Quezon City, 1102, Philippines

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Singapore, 169608, Singapore

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Singapore, 308433, Singapore

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Seoul, Dongdaemun-gu, 130-872, South Korea

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Anyang-si, Gyeonggi-do, 14068, South Korea

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Anyang, 431-070, South Korea

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Gangdong, 5355, South Korea

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Hwaseong-si, 18450, South Korea

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Seongnam-si, 13620, South Korea

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Seoul, 05030, South Korea

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Seoul, 3080, South Korea

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Visterra Investigational Site

Seoul, 3722, South Korea

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Visterra Investigational Site

L'Hospitalet de Llobregat, B, 8907, Spain

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Visterra Investigational Site

Santander, CB, 39010, Spain

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Córdoba, CO, 14004, Spain

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Seville, SE, 41009, Spain

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Barcelona, 8025, Spain

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Madrid, 28034, Spain

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Seville, 41013, Spain

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Valencia, 46017, Spain

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Colombo, 800, Sri Lanka

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Kandy, 20000, Sri Lanka

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Nugegoda, Sri Lanka

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Kaohsiung City, 82445, Taiwan

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Kaohsiung City, 83301, Taiwan

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Keelung, 20104, Taiwan

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Visterra Investigational Site

New Taipei City, 23142, Taiwan

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New Taipei City, 23561, Taiwan

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Visterra Investigational Site

Xitun, 40705, Taiwan

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Bangkok, 10310, Thailand

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Chiang Mai, 50200, Thailand

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Visterra Investigational Site

Ratchathewi, 10400, Thailand

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Bradford, BD5 0NA, United Kingdom

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London, E11BB, United Kingdom

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Visterra Investigational Site

London, SE5 9RS, United Kingdom

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Visterra Investigational Site

London, W12 0HS, United Kingdom

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Visterra Investigational Site

Salford, M6 8HD, United Kingdom

Location

Related Publications (2)

• Mathur M, Barratt J, Chacko B, Chan TM, Kooienga L, Oh KH, Sahay M, Suzuki Y, Wong MG, Yarbrough J, Xia J, Pereira BJG; ENVISION Trial Investigators Group. A Phase 2 Trial of Sibeprenlimab in Patients with IgA Nephropathy. N Engl J Med. 2024 Jan 4;390(1):20-31. doi: 10.1056/NEJMoa2305635. Epub 2023 Nov 2.

  PMID: 37916620 RESULT

• Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.

  PMID: 38299639 DERIVED

Related Links

• Otsuka Clinical Trial Website
• Otsuka Clinical Trial Transparency

MeSH Terms

Conditions

Glomerulonephritis, IGA; Kidney Diseases; Glomerulonephritis; Nephritis; Autoimmune Diseases; Immune System Diseases; Proteinuria

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Mohit Mathur, MD
• Organization: Visterra, Inc.

mmathur@visterrainc.com

+1-617-498-1070

Study Officials

• Asher Schachter, M.D.

  Visterra, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patient, Investigator, Care Provider, Outcomes Assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 27, 2020
• Study Start: July 20, 2020
• Primary Completion: May 19, 2023
• Study Completion: June 18, 2023
• Last Updated: April 24, 2026
• Results First Posted: November 21, 2024

Record last verified: 2026-04

Locations

GB (5); JP (11); PH (2); SG (2); IN (11); TW (6); MY (5); TH (3); AU (4); US (17); HK (4); SR (3); ES (8); KR (9); CA (3)