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New drug shows promise for kidney disease in phase 2 trial

NCT ID NCT04287985

Disease control Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug called VIS649 in 155 adults with IgA nephropathy, a kidney disease. The goal was to see if the drug is safe and can reduce protein in the urine, a sign of kidney damage. Participants received either the drug or a placebo, and researchers monitored side effects and urine protein levels over several months.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

155 people

The number who actually took part.

Started

Jul 2020

Finished

Jun 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: 1. Participant is a male or female ≥ 18 years of age at the time of signing the informed consent. 2. Participant must have biopsy-confirmed IgAN. 3. 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. 4. 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. 5. Participants must have eGFR ≥ 45 mL/min/1.73 m² using the CKD-EPI formula. 6. Participant's serum Ig values must meet specified criteria 7. Female participants of childbearing potential must have a negative serum pregnancy test prior to the first dose. 8. Participant is willing to adhere to contraceptive requirements. 9. Participant or a legally authorized representative is able and is willing to give voluntary written informed consent Exclusion Criteria: Participants are excluded from the study if they meet any of the following criteria: 1. Participant has secondary forms of IgAN as defined by the treating physician. 2. Participant has co-existing CKD, other than IgAN. 3. 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. 4. Participant has kidney biopsy MEST or MEST-C score as defined in the protocol. 5. Participant has nephrotic syndrome. 6. Participant has received a solid organ transplant, including kidney. 7. Participant has received bone marrow or hematologic stem cell transplantation. 8. Participant is currently receiving systemic immunosuppression (excluding topical, ophthalmic, per rectum, or inhaled corticosteroids). 9. Participant has received treatment with systemic corticosteroid therapy within 16 weeks of initial screening. 10. Participant has received treatment with a systemic immunosuppressive agents within 16 weeks of initial screening. 11. Participant has any chronic infectious disease. 12. Participant has acute infectious disease at the time of screening. 13. Participant has Type 1 diabetes. 14. Participant has uncontrolled Type 2 diabetes, as evidenced by a screening hemoglobin A1c value \> 8%. 15. Participant has uncontrolled BP (\> 140 mm Hg systolic or \> 90 mm Hg diastolic) 16. Participant has a history of chronic autoimmune neurodegenerative disorder such as multiple sclerosis. 17. Participant has a known allergy or intolerance to any component of the study intervention. 18. Participant is breastfeeding. 19. Participant has poorly compensated or controlled ischemic heart disease or cardiomyopathy, as judged by the Investigator. 20. Participant has chronic obstructive pulmonary disease (COPD) or asthma that has required systemic steroid therapy during the prior year. 21. Participant has known cirrhosis or liver dysfunction, defined as presence of coagulopathy, platelet count \< 100,000/μL or alanine aminotransferase \> 3× upper limit of normal. 22. Participant has active malignancy or is receiving chemotherapy for malignancy, except for nonmelanoma skin cancers and cervical carcinoma in situ. Participants with prior malignancy who have been documented to be cancer-free for ≥ 5 years may be enrolled. 23. Participant is planning or scheduled to undergo a tonsillectomy. Prior tonsillectomy is acceptable (if greater than 6 months prior to screening). 24. Participant enrolled in another investigational drug or device study within 3 months prior to initial screening. 25. Participant with a pre-existing illness other than those listed above that, in the opinion of the Investigator, would place the participant at increased risk through participation in this study. 26. Participant is unable to comply with study protocol procedures and/or study visit schedules. 27. Participant with known or suspected alcohol or drug abuse that would compromise their safety or study participation of the participant, in the opinion of the Investigator.

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Conditions

The condition(s) this trial relates to.

autoimmune disease glomerular disorder glomerulonephritis IgA glomerulonephritis IgA nephropathy, susceptibility to, 1 immune system disorder kidney disorder nephritis proteinuria

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Glomerular disease IGAN Immunoglobulin A nephropathy

Contacts and locations

Locations

  • Visterra Investigational Site

    Birmingham, Alabama, 35294, United States

  • Visterra Investigational Site

    Los Angeles, California, 90027, United States

  • Visterra Investigational Site

    Oxnard, California, 93036, United States

  • Visterra Investigational Site

    Palo Alto, California, 94305, United States

  • Visterra Investigational Site

    Stanford, California, 94305, United States

  • Visterra Investigational Site

    Denver, Colorado, 80230, United States

  • Visterra Investigational Site

    Lawrenceville, Georgia, 30046, United States

  • Visterra Investigational Site

    Baton Rouge, Louisiana, 70808, United States

  • Visterra Investigational Site

    New Orleans, Louisiana, 70121, United States

  • Visterra Investigational Site

    Baltimore, Maryland, 21201, United States

  • Visterra Investigational Site

    Tupelo, Mississippi, 38801, United States

  • Visterra Investigational Site

    New York, New York, 10016, United States

  • Visterra Investigational Site

    Chapel Hill, North Carolina, 27599, United States

  • Visterra Investigational Site

    Columbus, Ohio, 43210, United States

  • Visterra Investigational Site

    Bethlehem, Pennsylvania, 18017, United States

  • Visterra Investigational Site

    Houston, Texas, 77030, United States

  • Visterra Investigational Site

    Houston, Texas, 77054, United States

  • Visterra Investigational Site

    New Lambton Heights, New South Wales, 2305, Australia

  • Visterra Investigational Site

    Saint Leonards, New South Wales, 2065, Australia

  • Visterra Investigational Site

    Nambour, Queensland, 4560, Australia

  • Visterra Investigational Site

    Nedlands, Western Australia, 6009, Australia

  • Visterra Investigational Site

    Calgary, Alberta, T2N 2T9, Canada

  • Visterra Investigational Site

    Brampton, Ontario, L6R 3J7, Canada

  • Visterra Investigational Site

    Montreal, Quebec, H4A 3J1, Canada

  • Visterra Investigational Site

    Hong Kong, HK, Hong Kong

  • Visterra Investigational Site

    Hong Kong, Hong Kong

  • Visterra Investigational Site

    Kowloon, 999077, Hong Kong

  • Visterra Investigational Site

    Tsuen Wan, Hong Kong

  • Visterra Investigational Site

    Chandigarh, Chandigarh, 160012, India

  • Visterra Investigational Site

    Bangalore, Karnataka, 560054, India

  • Visterra Investigational Site

    Bengaluru, Karnataka, 560034, India

  • Visterra Investigational Site

    Manipal, Karnataka, 576104, India

  • Visterra Investigational Site

    Kozhikode, Kerala, 673008, India

  • Visterra Investigational Site

    Thiruvananthapuram, Kerala, 695011, India

  • Visterra Investigational Site

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

  • Visterra Investigational Site

    Vellore, Tamil Nadu, 632004, India

  • Visterra Investigational Site

    Hyderabad, Telangana, 500012, India

  • Visterra Investigational Site

    Hyderabad, Telangana, 500082, India

  • Visterra Investigational Site

    Raebareli, Uttar Pradesh, 226014, India

  • Visterra Investigational Site

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

  • Visterra Investigational Site

    Tokyo, Nerima Ku, 177-8521, Japan

  • Visterra Investigational Site

    Ashikaga, Tochigi, 326-0843, Japan

  • Visterra Investigational Site

    Ashikaga-Shi, 326-0843, Japan

  • Visterra Investigational Site

    Bunkyō City, 113-8431, Japan

  • Visterra Investigational Site

    Kashihara-shi, 634-8522, Japan

  • Visterra Investigational Site

    Minatoku, 470-1192, Japan

  • Visterra Investigational Site

    Niigata, 951-8520, Japan

  • Visterra Investigational Site

    Shinjuku-Ku, 162-8666, Japan

  • Visterra Investigational Site

    Tsukuba, 305-876, Japan

  • Visterra Investigational Site

    Urayasu-Shi, 279-0021, Japan

  • Visterra Investigational Site

    Klang, 41200, Malaysia

  • Visterra Investigational Site

    Kuala Lumpur, 56000, Malaysia

  • Visterra Investigational Site

    Kuala Lumpur, 59100, Malaysia

  • Visterra Investigational Site

    Kuantan, 25100, Malaysia

  • Visterra Investigational Site

    Seremban, 70300, Malaysia

  • Visterra Investigational Site

    Diliman, 1101, Philippines

  • Visterra Investigational Site

    Quezon City, 1102, Philippines

  • Visterra Investigational Site

    Singapore, 169608, Singapore

  • Visterra Investigational Site

    Singapore, 308433, Singapore

  • Visterra Investigational Site

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

  • Visterra Investigational Site

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

  • Visterra Investigational Site

    Anyang, 431-070, South Korea

  • Visterra Investigational Site

    Gangdong, 5355, South Korea

  • Visterra Investigational Site

    Hwaseong-si, 18450, South Korea

  • Visterra Investigational Site

    Seongnam-si, 13620, South Korea

  • Visterra Investigational Site

    Seoul, 05030, South Korea

  • Visterra Investigational Site

    Seoul, 3080, South Korea

  • Visterra Investigational Site

    Seoul, 3722, South Korea

  • Visterra Investigational Site

    L'Hospitalet de Llobregat, B, 8907, Spain

  • Visterra Investigational Site

    Santander, CB, 39010, Spain

  • Visterra Investigational Site

    Córdoba, CO, 14004, Spain

  • Visterra Investigational Site

    Seville, SE, 41009, Spain

  • Visterra Investigational Site

    Barcelona, 8025, Spain

  • Visterra Investigational Site

    Madrid, 28034, Spain

  • Visterra Investigational Site

    Seville, 41013, Spain

  • Visterra Investigational Site

    Valencia, 46017, Spain

  • Visterra Investigational Site

    Colombo, 800, Sri Lanka

  • Visterra Investigational Site

    Kandy, 20000, Sri Lanka

  • Visterra Investigational Site

    Nugegoda, Sri Lanka

  • Visterra Investigational Site

    Kaohsiung City, 82445, Taiwan

  • Visterra Investigational Site

    Kaohsiung City, 83301, Taiwan

  • Visterra Investigational Site

    Keelung, 20104, Taiwan

  • Visterra Investigational Site

    New Taipei City, 23142, Taiwan

  • Visterra Investigational Site

    New Taipei City, 23561, Taiwan

  • Visterra Investigational Site

    Xitun, 40705, Taiwan

  • Visterra Investigational Site

    Bangkok, 10310, Thailand

  • Visterra Investigational Site

    Chiang Mai, 50200, Thailand

  • Visterra Investigational Site

    Ratchathewi, 10400, Thailand

  • Visterra Investigational Site

    Bradford, BD5 0NA, United Kingdom

  • Visterra Investigational Site

    London, E11BB, United Kingdom

  • Visterra Investigational Site

    London, SE5 9RS, United Kingdom

  • Visterra Investigational Site

    London, W12 0HS, United Kingdom

  • Visterra Investigational Site

    Salford, M6 8HD, United Kingdom

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