Trial · NCT03598036
Dose-Exploration Evaluating the Efficacy and Safety of Voclosporin in Subjects With Focal Segmental Glomerulosclerosis
NCT03598036, Phase 2, Terminated, Aurinia Pharmaceuticals Inc.; results first posted 2021-09-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dose-Exploration Evaluating the Efficacy and Safety of Voclosporin in Subjects With Focal Segmental Glomerulosclerosis. Trials, record NCT03598036. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03598036
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose-Exploration Evaluating the Efficacy and Safety of Voclosporin in Subjects With Focal Segmental Glomerulosclerosis
- NCT number
- NCT03598036
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 5 participants, actual
- Lead sponsor
- Aurinia Pharmaceuticals Inc.
- Conditions
- Focal Segmental Glomerulosclerosis
- Interventions
- Voclosporin
- First posted
- 2018-07-26
- Last updated
- 2021-09-16
- Results first posted
- 2021-09-16
- Limitations and caveats
Due to difficulties enrolling appropriate Focal Segmental Glomerulosclerosis (FSGS) patients, Aurinia terminated the clinical trial early. Focal Segmental Glomerulosclerosis (FSGS) is a rare disease with an estimated 40,000 adult patients in the USA. Only five subjects were enrolled into the clinical trial.
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Subjects With Remission of Proteinuria | 24 weeks | Complete remission OR Partial remission |
| Secondary | Proportion of Subjects With Complete Remission or Partial Remission of Proteinuria | Weeks 8 and 12 | Complete remission or partial remission of proteinuria |
| Secondary | Proportion of Subjects With Complete Remission of Proteinuria | Weeks 8, 12, and 24 | Complete remission of proteinuria |
| Secondary | Proportion of Subjects With Reduction of Proteinuria | Weeks 8, 12, and 24 | Reduction of proteinuria |
| Secondary | Proportion of Subjects With Partial Remission of Proteinuria | Weeks 8, 12, and 24 | Partial remission of proteinuria |
| Secondary | Time to First Occurrence of Complete or Partial Remission of Proteinuria | Up to 26 weeks | Complete OR partial remission of proteinuria |
| Secondary | Time to First Occurrence of Complete Remission of Proteinuria | Up to 26 weeks | Complete remission of proteinuria |
| Secondary | Time to First Occurrence of Partial Remission of Proteinuria | Up to 26 weeks | Partial remission of proteinuria |
| Secondary | Time to First Occurrence of 50% Reduction in Urine Protein Creatinine Ratio (UPCR) From Baseline | Up to 26 weeks | 50% reduction in Urine Protein Creatinine Ratio (UPCR) from baseline |
| Secondary | Duration of Reduced Urine Protein Creatinine Ratio (UPCR) | Up to 26 weeks | Duration of reduced Urine Protein Creatinine Ratio (UPCR) |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Subjects With Remission of Proteinuria | 24 weeks | Due to difficulties enrolling appropriate Focal Segmental Glomerulosclerosis (FSGS) patients, Aurinia terminated the clinical trial early. Focal Segmental Glomerulosclerosis (FSGS) is a rare disease with an estimated 40,000 adult patients in the USA. Only five subjects were enrolled into the clinical trial. The primary and secondary endpoints were not assessed due to insufficient data collected | ||
| SECONDARY | Proportion of Subjects With Complete Remission or Partial Remission of Proteinuria | Weeks 8 and 12 | Due to difficulties enrolling appropriate Focal Segmental Glomerulosclerosis (FSGS) patients, Aurinia terminated the clinical trial early. Focal Segmental Glomerulosclerosis (FSGS) is a rare disease with an estimated 40,000 adult patients in the USA. Only five subjects were enrolled into the clinical trial. The primary and secondary endpoints were not assessed due to insufficient data collected. | ||
| SECONDARY | Proportion of Subjects With Complete Remission of Proteinuria | Weeks 8, 12, and 24 | Due to difficulties enrolling appropriate Focal Segmental Glomerulosclerosis (FSGS) patients, Aurinia terminated the clinical trial early. Focal Segmental Glomerulosclerosis (FSGS) is a rare disease with an estimated 40,000 adult patients in the USA. Only five subjects were enrolled into the clinical trial. The primary and secondary endpoints were not assessed due to insufficient data collected. | ||
| SECONDARY | Proportion of Subjects With Reduction of Proteinuria | Weeks 8, 12, and 24 | Due to difficulties enrolling appropriate Focal Segmental Glomerulosclerosis (FSGS) patients, Aurinia terminated the clinical trial early. Focal Segmental Glomerulosclerosis (FSGS) is a rare disease with an estimated 40,000 adult patients in the USA. Only five subjects were enrolled into the clinical trial. The primary and secondary endpoints were not assessed due to insufficient data collected. | ||
| SECONDARY | Proportion of Subjects With Partial Remission of Proteinuria | Weeks 8, 12, and 24 | Due to difficulties enrolling appropriate Focal Segmental Glomerulosclerosis (FSGS) patients, Aurinia terminated the clinical trial early. Focal Segmental Glomerulosclerosis (FSGS) is a rare disease with an estimated 40,000 adult patients in the USA. Only five subjects were enrolled into the clinical trial. The primary and secondary endpoints were not assessed due to insufficient data collected. | ||
| SECONDARY | Time to First Occurrence of Complete or Partial Remission of Proteinuria | Up to 26 weeks | Due to difficulties enrolling appropriate Focal Segmental Glomerulosclerosis (FSGS) patients, Aurinia terminated the clinical trial early. Focal Segmental Glomerulosclerosis (FSGS) is a rare disease with an estimated 40,000 adult patients in the USA. Only five subjects were enrolled into the clinical trial. The primary and secondary endpoints were not assessed due to insufficient data collected. | ||
| SECONDARY | Time to First Occurrence of Complete Remission of Proteinuria | Up to 26 weeks | Due to difficulties enrolling appropriate Focal Segmental Glomerulosclerosis (FSGS) patients, Aurinia terminated the clinical trial early. Focal Segmental Glomerulosclerosis (FSGS) is a rare disease with an estimated 40,000 adult patients in the USA. Only five subjects were enrolled into the clinical trial. The primary and secondary endpoints were not assessed due to insufficient data collected. | ||
| SECONDARY | Time to First Occurrence of Partial Remission of Proteinuria | Up to 26 weeks | Due to difficulties enrolling appropriate Focal Segmental Glomerulosclerosis (FSGS) patients, Aurinia terminated the clinical trial early. Focal Segmental Glomerulosclerosis (FSGS) is a rare disease with an estimated 40,000 adult patients in the USA. Only five subjects were enrolled into the clinical trial. The primary and secondary endpoints were not assessed due to insufficient data collected. | ||
| SECONDARY | Time to First Occurrence of 50% Reduction in Urine Protein Creatinine Ratio (UPCR) From Baseline | Up to 26 weeks | Due to difficulties enrolling appropriate Focal Segmental Glomerulosclerosis (FSGS) patients, Aurinia terminated the clinical trial early. Focal Segmental Glomerulosclerosis (FSGS) is a rare disease with an estimated 40,000 adult patients in the USA. Only five subjects were enrolled into the clinical trial. The primary and secondary endpoints were not assessed due to insufficient data collected. | ||
| SECONDARY | Duration of Reduced Urine Protein Creatinine Ratio (UPCR) | Up to 26 weeks | Due to difficulties enrolling appropriate Focal Segmental Glomerulosclerosis (FSGS) patients, Aurinia terminated the clinical trial early. Focal Segmental Glomerulosclerosis (FSGS) is a rare disease with an estimated 40,000 adult patients in the USA. Only five subjects were enrolled into the clinical trial. The primary and secondary endpoints were not assessed due to insufficient data collected. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Voclosporin Cohort 1 | 5 | |
| Overall Study | STARTED | Voclosporin Cohort 2 | 0 | |
| Overall Study | Week 1: 7.9 mg Twice Daily | Voclosporin Cohort 1 | 5 | |
| Overall Study | Week 1: 7.9 mg Twice Daily | Voclosporin Cohort 2 | 0 | |
| Overall Study | Week 2: 15.9 mg Twice Daily | Voclosporin Cohort 1 | 5 | |
| Overall Study | Week 2: 15.9 mg Twice Daily | Voclosporin Cohort 2 | 0 | |
| Overall Study | Weeks 3 - 24: 23.7 mg Twice Daily | Voclosporin Cohort 1 | 5 | |
| Overall Study | Weeks 3 - 24: 23.7 mg Twice Daily | Voclosporin Cohort 2 | 0 | |
| Overall Study | COMPLETED | Voclosporin Cohort 1 | 4 | |
| Overall Study | COMPLETED | Voclosporin Cohort 2 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events92
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 | Blood creatine phosphokinase increased | Investigations | Voclosporin Cohort 1: Week 1 | 1 | 5 | 1 |
| other | Blood creatine phosphokinase increased | Investigations | Voclosporin Cohort 1: Week 2 | 0 | 5 | 0 |
| other | Blood creatine phosphokinase increased | Investigations | Voclosporin Cohort 1: Weeks 3-24 | 2 | 5 | 2 |
| other | Blood creatine phosphokinase increased | Investigations | Voclosporin Cohort 2 | 0 | ||
| other | Glomerular filtration rate decreased | Investigations | Voclosporin Cohort 1: Week 1 | 0 | 5 | 0 |
| other | Glomerular filtration rate decreased | Investigations | Voclosporin Cohort 1: Week 2 | 0 | 5 | 0 |
| other | Glomerular filtration rate decreased | Investigations | Voclosporin Cohort 1: Weeks 3-24 | 3 | 5 | 3 |
| other | Glomerular filtration rate decreased | Investigations | Voclosporin Cohort 2 | 0 | ||
| other | Headache | Nervous system disorders | Voclosporin Cohort 1: Week 1 | 0 | 5 | 0 |
| other | Headache | Nervous system disorders | Voclosporin Cohort 1: Week 2 | 0 | 5 | 0 |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Voclosporin Cohort 1: Week 1 | 0 | 5 |
| Total, all-cause mortality | Voclosporin Cohort 1: Week 2 | 0 | 5 |
| Total, all-cause mortality | Voclosporin Cohort 1: Weeks 3-24 | 0 | 5 |
| Total, all-cause mortality | Voclosporin Cohort 2 | 0 | 0 |
| Total, other adverse events | Voclosporin Cohort 1: Week 1 | 2 | 5 |
| Total, other adverse events | Voclosporin Cohort 1: Week 2 | 0 | 5 |
| Total, other adverse events | Voclosporin Cohort 1: Weeks 3-24 | 5 | 5 |
| Total, other adverse events | Voclosporin Cohort 2 | 0 | 0 |
| Total, serious adverse events | Voclosporin Cohort 1: Week 1 | 0 | 5 |
| Total, serious adverse events | Voclosporin Cohort 1: Week 2 | 0 | 5 |
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/NCT03598036
GET https://conductscience.org/api/trials/v1/NCT03598036/events?page=2