Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04287985




Registration number
NCT04287985
Ethics application status
Date submitted
10/02/2020
Date registered
27/02/2020
Date last updated
27/10/2023

Titles & IDs
Public title
Safety and Efficacy Study of VIS649 for IgA Nephropathy
Scientific 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
Secondary ID [1] 0 0
2019-002531-29
Secondary ID [2] 0 0
VIS649-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Immunoglobulin A Nephropathy 0 0
Glomerular Disease 0 0
IgAN 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dose-Placebo
Treatment: Drugs - Low Dose-VIS649
Treatment: Drugs - Medium Dose-VIS649
Treatment: Drugs - High Dose-VIS649

Placebo comparator: Placebo - Placebo (0.9% NaCl) will be administered IV

Experimental: Low Dose - VIS649 - Low dose of VIS649 administered IV

Experimental: Medium Dose - VIS649 - Medium dose of VIS649 administered IV

Experimental: High Dose - VIS649 - High dose of VIS649 administered IV


Treatment: Drugs: Dose-Placebo
Unit Dose Strength - 0.9%.

Treatment: Drugs: Low Dose-VIS649
Dose Level = Low

Treatment: Drugs: Medium Dose-VIS649
Dose Level = Medium

Treatment: Drugs: High Dose-VIS649
Dose Level = High
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety Assessment
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
Efficacy Objective--effect on Proteinuria of repeated doses of VIS649 added to SOC (ACEI/ARB therapy) vs. SOC
Timepoint [2] 0 0
12 months
Secondary outcome [1] 0 0
Efficacy of repeated doses of VIS649 added to SOC (ACEI/ARB therapy) vs. SOC plus placebo
Timepoint [1] 0 0
9 months
Secondary outcome [2] 0 0
Efficacy of repeated doses of VIS649 added to SOC (ACEI/ARB therapy) vs. SOC plus placebo
Timepoint [2] 0 0
16 months
Secondary outcome [3] 0 0
Efficacy of repeated doses of VIS649 added to SOC (ACEI/ARB therapy) vs. SOC on protein excretion
Timepoint [3] 0 0
9 months
Secondary outcome [4] 0 0
Efficacy of repeated doses of VIS649 added to SOC (ACEI/ARB therapy) vs. SOC on protein excretion
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
Efficacy of repeated doses of VIS649 added to SOC (ACEI/ARB therapy) vs. SOC on protein excretion
Timepoint [5] 0 0
16 months
Secondary outcome [6] 0 0
Efficacy of repeated doses of VIS649 added to SOC (ACEI/ARB therapy) vs. SOC in achieving = 30% decline from baseline in uPCR
Timepoint [6] 0 0
9 months
Secondary outcome [7] 0 0
Efficacy of repeated doses of VIS649 added to SOC (ACEI/ARB therapy) vs. SOC in achieving = 30% decline from baseline in uPCR
Timepoint [7] 0 0
12 months
Secondary outcome [8] 0 0
Efficacy of repeated doses of VIS649 added to SOC (ACEI/ARB therapy) vs. SOC in achieving = 30% decline from baseline in uPCR
Timepoint [8] 0 0
16 months
Secondary outcome [9] 0 0
Efficacy of repeated doses of VIS649 added to SOC (ACEI/ARB therapy) vs. SOC on proteinuria
Timepoint [9] 0 0
up to 16 months
Secondary outcome [10] 0 0
Efficacy of repeated doses of VIS649 added to SOC (ACEI/ARB therapy) vs. SOC on kidney function.
Timepoint [10] 0 0
12 months
Secondary outcome [11] 0 0
Efficacy of repeated doses of VIS649 added to SOC (ACEI/ARB therapy) vs. SOC on kidney function.
Timepoint [11] 0 0
16 months
Secondary outcome [12] 0 0
Pharmacodynamics of repeated doses of VIS649 added to SOC (ACEI/ARB therapy) vs. SOC in total serum IgA, IgG and IgM concentrations
Timepoint [12] 0 0
9 months
Secondary outcome [13] 0 0
Pharmacodynamics of repeated doses of VIS649 added to SOC (ACEI/ARB therapy) vs. SOC in total serum IgA, IgG and IgM concentrations
Timepoint [13] 0 0
12 months
Secondary outcome [14] 0 0
Pharmacodynamics of repeated doses of VIS649 added to SOC (ACEI/ARB therapy) vs. SOC in total serum IgA, IgG and IgM concentrations
Timepoint [14] 0 0
16 months
Secondary outcome [15] 0 0
Serum PK parameters
Timepoint [15] 0 0
up to month 16
Secondary outcome [16] 0 0
Serum anti-drug-antibody (ADA)
Timepoint [16] 0 0
up to 16 months

Eligibility
Key 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.
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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/06/2023
Sample size
Target
Accrual to date
Final
155
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
Visterra Investigational Site - New Lambton Heights
Recruitment hospital [2] 0 0
Visterra Investigational Site - Saint Leonards
Recruitment hospital [3] 0 0
Visterra Investigational Site - Nambour
Recruitment hospital [4] 0 0
Visterra Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [2] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [3] 0 0
4560 - Nambour
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Mississippi
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
Canada
State/province [13] 0 0
Alberta
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec
Country [16] 0 0
Hong Kong
State/province [16] 0 0
HK
Country [17] 0 0
Hong Kong
State/province [17] 0 0
Hong Kong
Country [18] 0 0
Hong Kong
State/province [18] 0 0
Kowloon
Country [19] 0 0
Hong Kong
State/province [19] 0 0
Tsuen Wan
Country [20] 0 0
India
State/province [20] 0 0
CH
Country [21] 0 0
India
State/province [21] 0 0
DL
Country [22] 0 0
India
State/province [22] 0 0
KA
Country [23] 0 0
India
State/province [23] 0 0
KL
Country [24] 0 0
India
State/province [24] 0 0
TG
Country [25] 0 0
India
State/province [25] 0 0
TN
Country [26] 0 0
India
State/province [26] 0 0
UP
Country [27] 0 0
Japan
State/province [27] 0 0
Aichi
Country [28] 0 0
Japan
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Tochigi
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Japan
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Ashikaga-Shi
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Japan
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Bunkyo-Ku
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Japan
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Kashihara-shi
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Japan
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Minato-Ku
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Japan
State/province [33] 0 0
Nerima Ku
Country [34] 0 0
Japan
State/province [34] 0 0
Niigata Shi
Country [35] 0 0
Japan
State/province [35] 0 0
Shinjuku-Ku
Country [36] 0 0
Japan
State/province [36] 0 0
Tsukuba Shi
Country [37] 0 0
Japan
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Urayasu-Shi
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Anyang
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Korea, Republic of
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Dongdaemun-gu
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Korea, Republic of
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Gangdong
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Korea, Republic of
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Hwaseong-si
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Korea, Republic of
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Seongnam-si
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Korea, Republic of
State/province [44] 0 0
Seoul
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Malaysia
State/province [45] 0 0
Klang
Country [46] 0 0
Malaysia
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Kuala Lumpur
Country [47] 0 0
Malaysia
State/province [47] 0 0
Kuantan
Country [48] 0 0
Malaysia
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Seremban
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Philippines
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Diliman
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Philippines
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Quezon City
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Singapore
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Singapore
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Spain
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B
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Spain
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CB
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Spain
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CO
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Spain
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SE
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Spain
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Barcelona
Country [57] 0 0
Spain
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Madrid
Country [58] 0 0
Spain
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Sevilla
Country [59] 0 0
Spain
State/province [59] 0 0
Valencia
Country [60] 0 0
Sri Lanka
State/province [60] 0 0
Colombo
Country [61] 0 0
Sri Lanka
State/province [61] 0 0
Kandy
Country [62] 0 0
Sri Lanka
State/province [62] 0 0
Nugegoda
Country [63] 0 0
Taiwan
State/province [63] 0 0
Kaohsiung
Country [64] 0 0
Taiwan
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Keelung
Country [65] 0 0
Taiwan
State/province [65] 0 0
New Taipei City
Country [66] 0 0
Taiwan
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Xitun
Country [67] 0 0
Thailand
State/province [67] 0 0
Bangkok
Country [68] 0 0
Thailand
State/province [68] 0 0
Chiang Mai
Country [69] 0 0
Thailand
State/province [69] 0 0
Ratchathewi
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Bradford
Country [71] 0 0
United Kingdom
State/province [71] 0 0
London
Country [72] 0 0
United Kingdom
State/province [72] 0 0
Salford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Visterra, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Oldach, M.D., FIDSA
Address 0 0
Visterra, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04287985