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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 18 January 2021
Main ID:  NCT04287985
Date of registration: 10/02/2020
Prospective Registration: Yes
Primary sponsor: Visterra, Inc.
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
Date of first enrolment: July 20, 2020
Target sample size: 144
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT04287985
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 2
Countries of recruitment
Japan Korea, Republic of Spain United States
Contacts
Name:     Visterra Clinical Trial Information Line
Address: 
Telephone: 617-498-1070
Email: clinicaltrials@visterrainc.com
Affiliation: 
Name:     David Oldach, M.D., FIDSA
Address: 
Telephone:
Email:
Affiliation:  Visterra, Inc.
Key inclusion & exclusion criteria

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 medical records showing they have been on stable and maximally tolerated
doses of either ACEI or ARB, as per SOC and applicable guidelines, for at least 3
months preceding screening. 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 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 stable.

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

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 systemic steroids within the 24 weeks prior to initial
screening.

10. Participant has received treatment with 2 or more systemic immunosuppressive agents
within 2 years prior to initial screening.

11. Participant has chronic infectious diseases.

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Glomerular Disease
IgAN
Immunoglobulin A Nephropathy
Intervention(s)
Drug: Dose-Placebo
Drug: High Dose-VIS649
Drug: Low Dose-VIS649
Drug: Medium Dose-VIS649
Primary Outcome(s)
Efficacy Objective--effect on Proteinuria of repeated doses of VIS649 added to SOC (ACEI/ARB therapy) vs. SOC [Time Frame: 12 months]
Safety Assessment [Time Frame: 12 months]
Secondary Outcome(s)
Efficacy of repeated doses of VIS649 added to SOC (ACEI/ARB therapy) vs. SOC in achieving = 30% decline from baseline in uPCR [Time Frame: 12 months]
Efficacy of repeated doses of VIS649 added to SOC (ACEI/ARB therapy) vs. SOC in achieving = 30% decline from baseline in uPCR [Time Frame: 16 months]
Efficacy of repeated doses of VIS649 added to SOC (ACEI/ARB therapy) vs. SOC in achieving = 30% decline from baseline in uPCR [Time Frame: 9 months]
Efficacy of repeated doses of VIS649 added to SOC (ACEI/ARB therapy) vs. SOC on kidney function. [Time Frame: 12 months]
Efficacy of repeated doses of VIS649 added to SOC (ACEI/ARB therapy) vs. SOC on kidney function. [Time Frame: 16 months]
Efficacy of repeated doses of VIS649 added to SOC (ACEI/ARB therapy) vs. SOC on protein excretion [Time Frame: 12 months]
Efficacy of repeated doses of VIS649 added to SOC (ACEI/ARB therapy) vs. SOC on protein excretion [Time Frame: 16 months]
Efficacy of repeated doses of VIS649 added to SOC (ACEI/ARB therapy) vs. SOC on protein excretion [Time Frame: 9 months]
Efficacy of repeated doses of VIS649 added to SOC (ACEI/ARB therapy) vs. SOC on proteinuria [Time Frame: up to 16 months]
Efficacy of repeated doses of VIS649 added to SOC (ACEI/ARB therapy) vs. SOC plus placebo [Time Frame: 16 months]
Efficacy of repeated doses of VIS649 added to SOC (ACEI/ARB therapy) vs. SOC plus placebo [Time Frame: 9 months]
Pharmacodynamics of repeated doses of VIS649 added to SOC (ACEI/ARB therapy) vs. SOC in total serum IgA, IgG and IgM concentrations [Time Frame: 12 months]
Pharmacodynamics of repeated doses of VIS649 added to SOC (ACEI/ARB therapy) vs. SOC in total serum IgA, IgG and IgM concentrations [Time Frame: 16 months]
Pharmacodynamics of repeated doses of VIS649 added to SOC (ACEI/ARB therapy) vs. SOC in total serum IgA, IgG and IgM concentrations [Time Frame: 9 months]
Serum anti-drug-antibody (ADA) [Time Frame: up to 16 months]
Serum PK parameters [Time Frame: up to month 16]
Secondary ID(s)
2019-002531-29
U1111-1263-1268
VIS649-201
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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