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Immunoglobulin A NephropathyPhase 2NCT04287985

Safety and Efficacy Study of VIS649 for IgA Nephropathy

A Phase 2 study testing Low Dose-VIS649, Medium Dose-VIS649 and High Dose-VIS649 in people with Immunoglobulin A Nephropathy and Glomerular Disease, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 93 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
Low Dose-VIS649, Medium Dose-VIS649 and High Dose-VIS649
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
155 participants
Where
93 sitesin 15 countries
Study dates
20 Jul 2020to 18 Jun 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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

Who cannot join

  • 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.
Show all 28Show fewer
  • 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%.
  • Participant has uncontrolled BP (> 140 mm Hg systolic or > 90 mm Hg diastolic)
  • Participant has a history of chronic autoimmune neurodegenerative disorder such as multiple sclerosis.
  • Participant has a known allergy or intolerance to any component of the study intervention.
  • Participant is breastfeeding.
  • Participant has poorly compensated or controlled ischemic heart disease or cardiomyopathy, as judged by the Investigator.
  • Participant has chronic obstructive pulmonary disease (COPD) or asthma that has required systemic steroid therapy during the prior year.
  • 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.
  • 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.
  • Participant is planning or scheduled to undergo a tonsillectomy. Prior tonsillectomy is acceptable (if greater than 6 months prior to screening).
  • Participant enrolled in another investigational drug or device study within 3 months prior to initial screening.
  • 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.
  • Participant is unable to comply with study protocol procedures and/or study visit schedules.
  • 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.

Trial locations and contacts

93 sites in 15 countries.

93 sites in 15 countries

United States17 sites

  • Visterra Investigational Site

    Baltimore, Maryland, 21201

  • Visterra Investigational Site

    Baton Rouge, Louisiana, 70808

  • Visterra Investigational Site

    Bethlehem, Pennsylvania, 18017

  • Visterra Investigational Site

    Birmingham, Alabama, 35294

  • Visterra Investigational Site

    Chapel Hill, North Carolina, 27599

  • Visterra Investigational Site

    Columbus, Ohio, 43210

  • Visterra Investigational Site

    Denver, Colorado, 80230

  • Visterra Investigational Site

    Houston, Texas, 77030

  • Visterra Investigational Site

    Houston, Texas, 77054

  • Visterra Investigational Site

    Lawrenceville, Georgia, 30046

  • Visterra Investigational Site

    Los Angeles, California, 90027

  • Visterra Investigational Site

    New Orleans, Louisiana, 70121

  • Visterra Investigational Site

    New York, New York, 10016

  • Visterra Investigational Site

    Oxnard, California, 93036

  • Visterra Investigational Site

    Palo Alto, California, 94305

  • Visterra Investigational Site

    Stanford, California, 94305

  • Visterra Investigational Site

    Tupelo, Mississippi, 38801

Other trials in United States

India11 sites

  • Visterra Investigational Site

    Bangalore, Karnataka, 560054

  • Visterra Investigational Site

    Bengaluru, Karnataka, 560034

  • Visterra Investigational Site

    Chandigarh, Chandigarh, 160012

  • Visterra Investigational Site

    Hyderabad, Telangana, 500012

  • Visterra Investigational Site

    Hyderabad, Telangana, 500082

  • Visterra Investigational Site

    Kozhikode, Kerala, 673008

  • Visterra Investigational Site

    Manipal, Karnataka, 576104

  • Visterra Investigational Site

    New Delhi, National Capital Territory of Delhi, 110060

  • Visterra Investigational Site

    Raebareli, Uttar Pradesh, 226014

  • Visterra Investigational Site

    Thiruvananthapuram, Kerala, 695011

  • Visterra Investigational Site

    Vellore, Tamil Nadu, 632004

Other trials in India

Japan11 sites

  • Visterra Investigational Site

    Ashikaga, Tochigi, 326-0843

  • Visterra Investigational Site

    Ashikaga-Shi, 326-0843

  • Visterra Investigational Site

    Bunkyō City, 113-8431

  • Visterra Investigational Site

    Kashihara-shi, 634-8522

  • Visterra Investigational Site

    Minatoku, 470-1192

  • Visterra Investigational Site

    Niigata, 951-8520

  • Visterra Investigational Site

    Shinjuku-Ku, 162-8666

  • Visterra Investigational Site

    Tokyo, Nerima Ku, 177-8521

  • Visterra Investigational Site

    Toyoake-shi, Aichi-ken, 470-1192

  • Visterra Investigational Site

    Tsukuba, 305-876

  • Visterra Investigational Site

    Urayasu-Shi, 279-0021

Other trials in Japan

South Korea9 sites

  • Visterra Investigational Site

    Anyang, 431-070

  • Visterra Investigational Site

    Anyang-si, Gyeonggi-do, 14068

  • Visterra Investigational Site

    Gangdong, 5355

  • Visterra Investigational Site

    Hwaseong-si, 18450

  • Visterra Investigational Site

    Seongnam-si, 13620

  • Visterra Investigational Site

    Seoul, Dongdaemun-gu, 130-872

  • Visterra Investigational Site

    Seoul, 05030

  • Visterra Investigational Site

    Seoul, 3080

  • Visterra Investigational Site

    Seoul, 3722

Other trials in South Korea

Spain8 sites

  • Visterra Investigational Site

    Barcelona, 8025

  • Visterra Investigational Site

    Córdoba, CO, 14004

  • Visterra Investigational Site

    L'Hospitalet de Llobregat, B, 8907

  • Visterra Investigational Site

    Madrid, 28034

  • Visterra Investigational Site

    Santander, CB, 39010

  • Visterra Investigational Site

    Seville, SE, 41009

  • Visterra Investigational Site

    Seville, 41013

  • Visterra Investigational Site

    Valencia, 46017

Other trials in Spain

Taiwan6 sites

  • Visterra Investigational Site

    Kaohsiung City, 82445

  • Visterra Investigational Site

    Kaohsiung City, 83301

  • Visterra Investigational Site

    Keelung, 20104

  • Visterra Investigational Site

    New Taipei City, 23142

  • Visterra Investigational Site

    New Taipei City, 23561

  • Visterra Investigational Site

    Xitun, 40705

Other trials in Taiwan

Malaysia5 sites

  • Visterra Investigational Site

    Klang, 41200

  • Visterra Investigational Site

    Kuala Lumpur, 56000

  • Visterra Investigational Site

    Kuala Lumpur, 59100

  • Visterra Investigational Site

    Kuantan, 25100

  • Visterra Investigational Site

    Seremban, 70300

Other trials in Malaysia

United Kingdom5 sites

  • Visterra Investigational Site

    Bradford, BD5 0NA

  • Visterra Investigational Site

    London, E11BB

  • Visterra Investigational Site

    London, SE5 9RS

  • Visterra Investigational Site

    London, W12 0HS

  • Visterra Investigational Site

    Salford, M6 8HD

Other trials in United Kingdom

Australia4 sites

  • Visterra Investigational Site

    Nambour, Queensland, 4560

  • Visterra Investigational Site

    Nedlands, Western Australia, 6009

  • Visterra Investigational Site

    New Lambton Heights, New South Wales, 2305

  • Visterra Investigational Site

    Saint Leonards, New South Wales, 2065

Other trials in Australia

Hong Kong4 sites

  • Visterra Investigational Site

    Hong Kong, HK

  • Visterra Investigational Site

    Hong Kong

  • Visterra Investigational Site

    Kowloon, 999077

  • Visterra Investigational Site

    Tsuen Wan

Other trials in Hong Kong

Canada3 sites

  • Visterra Investigational Site

    Brampton, Ontario, L6R 3J7

  • Visterra Investigational Site

    Calgary, Alberta, T2N 2T9

  • Visterra Investigational Site

    Montreal, Quebec, H4A 3J1

Other trials in Canada

Sri Lanka3 sites

  • Visterra Investigational Site

    Colombo, 800

  • Visterra Investigational Site

    Kandy, 20000

  • Visterra Investigational Site

    Nugegoda

Other trials in Sri Lanka

Thailand3 sites

  • Visterra Investigational Site

    Bangkok, 10310

  • Visterra Investigational Site

    Chiang Mai, 50200

  • Visterra Investigational Site

    Ratchathewi, 10400

Other trials in Thailand

Philippines2 sites

  • Visterra Investigational Site

    Diliman, 1101

  • Visterra Investigational Site

    Quezon City, 1102

Other trials in Philippines

Singapore2 sites

  • Visterra Investigational Site

    Singapore, 169608

  • Visterra Investigational Site

    Singapore, 308433

Other trials in Singapore

About this study

Official title: 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

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

Read the detailed description

This is a Phase 2, double-blind, randomized, placebo-controlled study in patients aged 18 years and above with biopsy confirmed diagnosis of IgAN. The study is designed to test the safety and effectiveness of multiple doses of VIS649. The main objectives are to evaluate the safety and tolerability of VIS649 and to evaluate the dose response of different doses of VIS649 by measuring proteinuria.

The study is comprised of three main periods, Screening, Treatment (12 months) and Follow-Up (4 months). Approximately 144 patients will be enrolled. The findings from this study will form the basis for subsequent clinical development of VIS649.

VIS649 is a humanized immunoglobulin G (IgG2) monoclonal antibody that binds to and blocks the biological actions of the cytokine A PRoliferation Inducing Ligand (APRIL), a key factor in the production of aberrantly glycosylated IgA1 (a-g- IgA1), which is critical to the pathogenesis of IgAN.

Being tested
Dose-Placebo, Low Dose-VIS649, Medium Dose-VIS649, High Dose-VIS649
Keywords
VIS649, Kidney Diseases, Glomerulonephritis, IGA, Glomerulonephritis, Nephritis, Autoimmune Diseases, Immune System Diseases, Immunoglobulins, Antibodies, Immunoglobulin A, Immunologic Factors, Physiological Effects of Drugs, Proteinuria
Medical subject headings
Glomerulonephritis, IGA, Kidney Diseases, Glomerulonephritis, Nephritis, Autoimmune Diseases, Immune System Diseases, Proteinuria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dose-PlaceboDrug

    Unit Dose Strength - 0.9%.

  • Low Dose-VIS649Drug

    Dose Level = Low

  • Medium Dose-VIS649Drug

    Dose Level = Medium

  • High Dose-VIS649Drug

    Dose Level = High

Study groups in NCT04287985
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo, normal saline (0.9% NaCl) will be administered IV
Receives: Drug: Dose-Placebo
Low Dose - VIS649ExperimentalLow dose of VIS649 administered IV
Receives: Drug: Low Dose-VIS649
Medium Dose - VIS649ExperimentalMedium dose of VIS649 administered IV
Receives: Drug: Medium Dose-VIS649
High Dose - VIS649ExperimentalHigh dose of VIS649 administered IV
Receives: Drug: High Dose-VIS649

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Adverse Events Graded by Severity

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

    Measured: Baseline to End of Study (16 months)

  2. 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.

    Measured: Baseline to End of Study (16 months)

  3. 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.

    Measured: Baseline to End of Study (16 months)

  4. Clinically Significant Physical Examinations

    Clinically significant physical examination findings are presented.

    Measured: Baseline to End of Study (16 months)

  5. 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

    Measured: 12 months

Secondary outcomes (16)

  1. Change From Baseline in uPCR: Months 9 and 16

    Change from baseline in uPCR (Urine protein/creatinine ratio)

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

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

    Change in 24-hour urine protein excretion from baseline to Months 12 and 16

    Measured: 16 months

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

    Number of participants in each group achieving a greater than or equal to 30% decline from baseline in urinary protein/creatinine ratio (uPCR) at Months 9, 12, and 16

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

  4. Participants in Each Group Achieving Clinical Remission

    Number of participants in each group achieving clinical remission. Clinical remission was defined as reduction in 24-hour urine protein excretion to less than 300 mg/day for at least 3 consecutive months.

    Measured: Baseline to End of Study (16 months)

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

    Change from baseline in (eGFR) at Months 9, 12, and 16

    Measured: Baseline to 12 and 16 months

  6. Percent Change From Baseline in Total Serum IgA, IgG, and IgM Concentrations at Months 12 and 16

    Percent change from baseline in total serum immunoglobin (Ig)A, IgG, and IgM concentrations at Months 12 and 16 in PD population

    Measured: Baseline to 12 and 16 months

  7. Mean Serum PK Parameters at Month 0 and Month 11: Cmax

    Serum PK parameters: maximum serum concentration (Cmax)

    Measured: Months 0 and 11

  8. Median Serum PK Parameters at Month 0 and Month 11: Tmax

    Serum PK parameters: time of maximum serum concentration (Tmax)

    Measured: Month 0 and Month 11

  9. Mean Serum PK Parameters at Month 0: AUC0-inf and AUC0-30

    Serum PK parameters of area under the concentration-time curve from time 0 to infinity (AUC0-inf) and area under the concentration-time curve from time 0 to Day 30 (AUC0-30)

    Measured: Month 0

  10. Mean Serum PK Parameters at Month 0 and Month 11: t1/2z

    Serum PK parameters: terminal elimination half-life(t1/2z)

    Measured: Month 0 and Month 11

  11. Median Serum PK Parameters at Month 0: CL

    Serum PK parameters of clearance.

    8 mg/kg was not reported for this outcome measure. Other arms were not provided due to participants meeting exclusion criteria: %AUCext > 20% and R2 Adjusted < 0.8. Affected parameters at participant visits meeting this criteria were excluded.

    Measured: Month 0

  12. Mean Serum PK Parameters at Month 0: Vz

    Serum PK parameters of apparent volume of distribution (Vz).

    8 mg/kg was not reported for this outcome measure. Other arms were not provided due to participants meeting exclusion criteria: %AUCext > 20% and R2 Adjusted < 0.8. Affected parameters at participant visits meeting this criteria were excluded.

    Measured: Month 0

  13. Mean Serum PK Parameters at Month 11: AUCτ

    Serum PK parameters: area under the concentration-time curve from time 0 to the end of the dosing period (AUCτ)

    Measured: Month 11

  14. Mean Serum PK Parameters at Month 11: Vss

    Serum PK parameters: volume of distribution at steady-state (Vss)

    Measured: Month 11

  15. Mean Serum PK Parameters at Month 11: CLss

    Serum PK parameters: clearance at steady-state (CLss)

    Measured: Month 11

  16. Mean Serum PK Parameters at Month 11: Rac[AUC0-30]

    Serum PK parameters: accumulation ratio of area under the concentration-time curve from time 0 to infinity (Rac[AUC0-30])

    Measured: Month 11

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2020
  2. Study start20 Jul 2020
  3. Primary completion19 May 2023
  4. Study completion18 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
155 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04287985
Sponsor's protocol ID
VIS649-201
Other IDs
2019-002531-29, U1111-1263-1268, 2019
Status last verified
Apr 2026
First submitted
10 Feb 2020
Last updated
24 Apr 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 37916620

  • McCafferty K, Barratt J, Suzuki Y, Liew A, Rizk DV, Chacko B, Kooienga L, Lafayette R, Wong MG, Pasetti MF, Shriver MC, Follman K, Moc Willeford C, Sahay M, Honig G, Andrews L, Olinski LE, Mathur M, Oldach D. Humoral Response to COVID-19 Vaccines and Infection during Sibeprenlimab Treatment of IgA Nephropathy: Data from the ENVISION Trial. Clin J Am Soc Nephrol. 2026 Jun 11. doi: 10.2215/CJN.0000001089. Online ahead of print.

    PubMed 42275148

  • 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.

    PubMed 38299639

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Low Dose-VIS649, Medium Dose-VIS649 and High Dose-VIS649 in people with Immunoglobulin A Nephropathy and Glomerular Disease, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 93 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 93 sites in United States, India, Japan, South Korea, Spain and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events Graded by Severity (time frame: Baseline to End of Study (16 months)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04287985, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.

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