CompletedPhase 2

Safety and Efficacy Study of VIS649 for IgA Nephropathy

United States155 participantsStarted 2020-07-20

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion 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).

What they're measuring

Number of Participants With Adverse Events Graded by Severity

Timeframe: Baseline to End of Study (16 months)

Changes From Baseline in Clinical Laboratory Tests

Timeframe: Baseline to End of Study (16 months)

Clinically Meaningful Changes From Baseline in Vital Signs

Timeframe: Baseline to End of Study (16 months)

Clinically Significant Physical Examinations

Timeframe: Baseline to End of Study (16 months)

Change From Baseline in uPCR: Month 12

Timeframe: 12 months

Trial details

NCT IDNCT04287985

SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-05-19

Results submitted2024-08-02

View on ClinicalTrials.gov More Immunoglobulin A Nephropathy trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion 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).

What they're measuring

Number of Participants With Adverse Events Graded by Severity

Timeframe: Baseline to End of Study (16 months)

Changes From Baseline in Clinical Laboratory Tests

Timeframe: Baseline to End of Study (16 months)

Clinically Meaningful Changes From Baseline in Vital Signs

Timeframe: Baseline to End of Study (16 months)

Clinically Significant Physical Examinations

Timeframe: Baseline to End of Study (16 months)

Change From Baseline in uPCR: Month 12

Timeframe: 12 months