Trial · NCT04287985
Safety and Efficacy Study of VIS649 for IgA Nephropathy
NCT04287985, Phase 2, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2024-11-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy Study of VIS649 for IgA Nephropathy. Trials, record NCT04287985. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04287985
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of VIS649 for IgA Nephropathy
- NCT number
- NCT04287985
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 155 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Immunoglobulin A Nephropathy, Glomerular Disease, IgAN
- Interventions
- Dose-Placebo, Low Dose-VIS649, Medium Dose-VIS649, High Dose-VIS649
- First posted
- 2020-02-27
- Last updated
- 2026-04-24
- Other registries' IDs
- eudract:2019-002531-29
- Results first posted
- 2024-11-21
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events Graded by Severity | Baseline to End of Study (16 months) | The number of participants who experienced adverse events, graded by maximum severity, are presented. |
| Primary | Changes From Baseline in Clinical Laboratory Tests | Baseline to End of Study (16 months) | 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. |
| Primary | Clinically Meaningful Changes From Baseline in Vital Signs | Baseline to End of Study (16 months) | 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. |
| Primary | Clinically Significant Physical Examinations | Baseline to End of Study (16 months) | Clinically significant physical examination findings are presented. |
| Primary | Change From Baseline in uPCR: Month 12 | 12 months | Natural Log 24-Hour uPCR (Schedule A Urine Collection) Change from Baseline at Month 12: mixed model with repeated measurements |
| Secondary | Change From Baseline in uPCR: Months 9 and 16 | Baseline to 9 months and 16 months (16 months total) | Change from baseline in uPCR (Urine protein/creatinine ratio) |
| Secondary | Change in 24-hour Urine Protein Excretion: Months 12 and 16 | 16 months | Change in 24-hour urine protein excretion from baseline to Months 12 and 16 |
| Secondary | Participants Achieving a Greater Than or Equal to 30% Decline From Baseline in uPCR at Months 9, 12, and 16 | Baseline to 9,12, and 16 months (16 months total) | 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 |
| Secondary | Participants in Each Group Achieving Clinical Remission | Baseline to End of Study (16 months) | 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. |
| Secondary | Change From Baseline in eGFR at Months 9, 12, and 16 | Baseline to 12 and 16 months | Change from baseline in (eGFR) at Months 9, 12, and 16 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events Graded by Severity | Baseline to End of Study (16 months) | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Changes From Baseline in Clinical Laboratory Tests | Baseline to End of Study (16 months) | Safety population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Clinically Meaningful Changes From Baseline in Vital Signs | Baseline to End of Study (16 months) | Safety population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Clinically Significant Physical Examinations | Baseline to End of Study (16 months) | Safety population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in uPCR: Month 12 | 12 months | modified intent-to-treat (mITT) Population | g/g | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in uPCR: Months 9 and 16 | Baseline to 9 months and 16 months (16 months total) | modified intent-to-treat (mITT) Population | g/g | LEAST_SQUARES_MEAN |
| SECONDARY | Change in 24-hour Urine Protein Excretion: Months 12 and 16 | 16 months | modified intent-to-treat (mITT) Population | mg/day | GEOMETRIC_MEAN |
| SECONDARY | Participants Achieving a Greater Than or Equal to 30% Decline From Baseline in uPCR at Months 9, 12, and 16 | Baseline to 9,12, and 16 months (16 months total) | modified intent-to-treat (mITT) Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants in Each Group Achieving Clinical Remission | Baseline to End of Study (16 months) | modified intent-to-treat (mITT) Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in eGFR at Months 9, 12, and 16 | Baseline to 12 and 16 months | modified intent-to-treat (mITT) Population | mL/min/1.73 m^2 | MEAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group199
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events Graded by Severity | VIS649 2 mg/kg | TEAE with a maximum severity of mild | 19 | Participants | |
| Number of Participants With Adverse Events Graded by Severity | VIS649 4 mg/kg | TEAE with a maximum severity of mild | 22 | Participants | |
| Number of Participants With Adverse Events Graded by Severity | VIS649 8 mg/kg | TEAE with a maximum severity of mild | 22 | Participants | |
| Number of Participants With Adverse Events Graded by Severity | Placebo | TEAE with a maximum severity of mild | 23 | Participants | |
| Number of Participants With Adverse Events Graded by Severity | VIS649 2 mg/kg | TEAE with a maximum severity of moderate | 7 | Participants | |
| Number of Participants With Adverse Events Graded by Severity | VIS649 4 mg/kg | TEAE with a maximum severity of moderate | 9 | Participants | |
| Number of Participants With Adverse Events Graded by Severity | VIS649 8 mg/kg | TEAE with a maximum severity of moderate | 8 | Participants | |
| Number of Participants With Adverse Events Graded by Severity | Placebo | TEAE with a maximum severity of moderate | 3 | Participants | |
| Number of Participants With Adverse Events Graded by Severity | VIS649 2 mg/kg | TEAE with a maximum severity of severe | 2 | Participants | |
| Number of Participants With Adverse Events Graded by Severity | VIS649 4 mg/kg | TEAE with a maximum severity of severe | 2 | Participants |
1 to 10 of 199Source ClinicalTrials.gov
See all 199 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | VIS649 2 mg/kg | 38 | |
| Overall Study | STARTED | VIS649 4 mg/kg | 41 | |
| Overall Study | STARTED | VIS649 8 mg/kg | 38 | |
| Overall Study | STARTED | Placebo | 38 | |
| Overall Study | COMPLETED | VIS649 2 mg/kg | 35 | |
| Overall Study | COMPLETED | VIS649 4 mg/kg | 39 | |
| Overall Study | COMPLETED | VIS649 8 mg/kg | 37 | |
| Overall Study | COMPLETED | Placebo | 35 | |
| Overall Study | NOT COMPLETED | VIS649 2 mg/kg | 3 | |
| Overall Study | NOT COMPLETED | VIS649 4 mg/kg | 2 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events896
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | VIS649 2 mg/kg | 1 | 38 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | VIS649 4 mg/kg | 0 | 41 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | VIS649 8 mg/kg | 0 | 38 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Placebo | 0 | 38 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | VIS649 2 mg/kg | 0 | 38 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | VIS649 4 mg/kg | 1 | 41 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | VIS649 8 mg/kg | 0 | 38 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Placebo | 0 | 38 | |
| other | Polycythaemia | Blood and lymphatic system disorders | VIS649 2 mg/kg | 0 | 38 | |
| other | Polycythaemia | Blood and lymphatic system disorders | VIS649 4 mg/kg | 0 | 41 |
1 to 10 of 896Source ClinicalTrials.gov
See all 896 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | VIS649 2 mg/kg | 0 | 38 |
| Total, all-cause mortality | VIS649 4 mg/kg | 0 | 41 |
| Total, all-cause mortality | VIS649 8 mg/kg | 0 | 38 |
| Total, all-cause mortality | Placebo | 1 | 38 |
| Total, other adverse events | VIS649 2 mg/kg | 28 | 38 |
| Total, other adverse events | VIS649 4 mg/kg | 33 | 41 |
| Total, other adverse events | VIS649 8 mg/kg | 31 | 38 |
| Total, other adverse events | Placebo | 27 | 38 |
| Total, serious adverse events | VIS649 2 mg/kg | 2 | 38 |
| Total, serious adverse events | VIS649 4 mg/kg | 2 | 41 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04287985
GET https://conductscience.org/api/trials/v1/NCT04287985/registered?page=2