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Immunosuppressant

Voclosporin for Lupus Nephritis (VOCAL-EXT Trial)

Phase 3
Waitlist Available
Research Sponsored by Aurinia Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject is willing to continue to take oral MMF for the duration of the study
Be younger than 65 years old
Must not have
Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period
Currently taking or known need for any of the following medications during the study: Cholestyramine or other drugs that may interfere with enterohepatic recirculation of MMF, Calcineurin inhibitors (CNIs) (e.g., cyclosporin and tacrolimus), Strong CYP3A4/5 inhibitors and inducers (e.g., ketoconazole, rifampin, itraconazole, clarithromycin)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 12 (vocal study completion/vocal-ext study start) and month 18 (vocal-ext study completion)
Awards & highlights

Summary

This trial tests the long-term safety of a drug used to treat active lupus nephritis in teens.

Who is the study for?
This trial is for adolescents with active lupus nephritis who have completed a previous voclosporin study and need ongoing immunosuppressive therapy. They must be willing to take oral MMF throughout the study and not require dialysis or a kidney transplant during the trial.
What is being tested?
The trial tests the long-term safety of voclosporin in treating lupus nephritis over an additional 12 months, following up on earlier treatment from the VOCAL study. Participants will continue their current medication regimen alongside voclosporin.
What are the potential side effects?
While specific side effects are not listed here, typical ones associated with immunosuppressants like voclosporin may include increased risk of infections, headaches, high blood pressure, nausea, and possible kidney function impairment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing to take oral MMF for the study duration.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am on or expected to need kidney dialysis during the study.
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I am not taking drugs that affect MMF absorption or strong CYP3A4/5 inhibitors.
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I am scheduled for a kidney transplant during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 12 (vocal study completion/vocal-ext study start) and month 18 (vocal-ext study completion)
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 12 (vocal study completion/vocal-ext study start) and month 18 (vocal-ext study completion) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Treatment Emergent Adverse Events (TEAE)
Secondary study objectives
Partial Renal Response
Renal Response
Urine Protein Creatinine Ratio (UPCR)

Side effects data

From 2005 Phase 3 trial • 451 Patients • NCT00244842
25%
Nasopharyngitis
17%
Headache
11%
Upper respiratory tract infection
7%
Hypertension
5%
Back pain
4%
Blood pressure increased
3%
Vomiting
2%
Arthralgia
2%
Diarrhoea
1%
Convulsion
1%
Basal Cell Carcinoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Voclosporin 0.2
Voclosporin 0.3
Voclosporin 0.4

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open LabelExperimental Treatment1 Intervention
All subjects will receive open label voclosporin initially at the same number of capsules as assigned at Week 24 (End of Study Visit) in AUR-VCS-2020-03 (VOCAL ; NCT05288855). At the Investigator's discretion and after consultation with the Medical Monitor, dose titration up or down in the study will be permitted up to the maximum dose that was studied in AUR-VCS-2020-03.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
voclosporin
2006
Completed Phase 3
~1420

Find a Location

Who is running the clinical trial?

Labcorp Corporation of America Holdings, IncIndustry Sponsor
19 Previous Clinical Trials
4,576 Total Patients Enrolled
1 Trials studying Lupus Nephritis
40 Patients Enrolled for Lupus Nephritis
Aurinia Pharmaceuticals Inc.Lead Sponsor
17 Previous Clinical Trials
3,622 Total Patients Enrolled
6 Trials studying Lupus Nephritis
1,189 Patients Enrolled for Lupus Nephritis

Media Library

Voclosporin (Immunosuppressant) Clinical Trial Eligibility Overview. Trial Name: NCT05962788 — Phase 3
Lupus Nephritis Research Study Groups: Open Label
Lupus Nephritis Clinical Trial 2023: Voclosporin Highlights & Side Effects. Trial Name: NCT05962788 — Phase 3
Voclosporin (Immunosuppressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05962788 — Phase 3
~27 spots leftby Jun 2026
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