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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
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
VOCAL-EXT Trial 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.Check my eligibility
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.See study design
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.
VOCAL-EXT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am willing to take oral MMF for the study duration.
VOCAL-EXT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 12 (vocal study completion/vocal-ext study start) and month 18 (vocal-ext study completion)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 12 (vocal study completion/vocal-ext study start) and month 18 (vocal-ext study completion)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Treatment Emergent Adverse Events (TEAE)
Secondary outcome measures
Partial Renal Response
Renal Response
Urine Protein Creatinine Ratio (UPCR)
Side effects data
From 2005 Phase 3 trial • 451 Patients • NCT0024484225%
Nasopharyngitis
17%
Headache
11%
Upper respiratory tract infection
7%
Hypertension
5%
Back pain
4%
Blood pressure increased
3%
Vomiting
2%
Diarrhoea
2%
Arthralgia
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
VOCAL-EXT 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
18 Previous Clinical Trials
4,186 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on or expected to need kidney dialysis during the study.I am willing to take oral MMF for the study duration.I have given my consent to participate in this study.I am not taking drugs that affect MMF absorption or strong CYP3A4/5 inhibitors.I am scheduled for a kidney transplant during the study.You have finished 24 weeks of treatment with the study drug in the VOCAL study. If you had a temporary break from the study drug and started taking it again successfully, you can join with approval from the medical monitor.
Research Study Groups:
This trial has the following groups:- Group 1: Open Label
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an age cutoff for participants in this clinical trial?
"In accordance with the trial's criteria, potential participants must be between 12 and 18 years old."
Answered by AI
Does Open Label present any risks to those enrolled in the program?
"Given the evidence of efficacy and safety evident in Phase 3 trials, we evaluated Open Label with a score of 3 on our risk assessment scale."
Answered by AI
Who might be the ideal candidates for this medical experiment?
"Prospective participants must be aged between 12 and 18, as well as suffer from lupus nephritis. 40 individuals are expected to join the trial."
Answered by AI
Is recruitment for this research endeavor still open?
"The information on clinicaltrials.gov suggest that this trial is not currently enrolling patients, despite having been uploaded to the database in December 1st 2023 and last updated on July 18th 2023. However, there are currently 54 other trials searching for participants at present."
Answered by AI
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