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Immunosuppressant
Voclosporin for Lupus Nephritis (VOCAL Trial)
Phase 3
Recruiting
Research Sponsored by Aurinia Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Previous diagnosis of systemic lupus erythematosus (SLE) as per the 2019 EULAR/ ACR classification criteria
Subjects with kidney biopsy confirmed active lupus nephritis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24
Awards & highlights
VOCAL Trial Summary
This trial is testing if a new drug, voclosporin, is better than placebo at improving kidney function in teens with active lupus nephritis.
Who is the study for?
Adolescents previously diagnosed with systemic lupus erythematosus and confirmed active lupus nephritis can join. They must have a kidney function above a certain level (eGFR >60) and not be immunocompromised or have significant drug/alcohol abuse, cancer, severe infections like HIV or hepatitis, TB without prophylaxis, or require dialysis.Check my eligibility
What is being tested?
The trial is testing the effectiveness of voclosporin against a placebo in treating lupus nephritis over 24 weeks. Participants will either receive voclosporin capsules or placebo to see if there's an improvement in their kidney condition.See study design
What are the potential side effects?
While specific side effects for this trial are not listed here, voclosporin may generally cause immune system suppression leading to increased infection risk, potential kidney problems, high blood pressure, tremors, and possible interactions with other drugs.
VOCAL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with lupus according to the 2019 criteria.
Select...
My kidney biopsy confirmed I have active lupus nephritis.
VOCAL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of subjects with renal response
Secondary outcome measures
Number of treatment-emergent adverse events (TEAEs) will be summarized by treatment group
Proportion of subjects with partial renal response
Time to 50% Reduction in UPCR
+1 moreSide effects data
From 2019 Phase 3 trial • 358 Patients • NCT0302149924%
Glomerular filtration rate decreased
20%
Hypertension
19%
Diarrhoea
17%
Upper respiratory tract infection
16%
Headache
11%
Viral upper respiratory tract infection
10%
Anaemia
10%
Urinary tract infection
7%
Herpes zoster
7%
Cough
7%
Influenza
7%
Abdominal pain upper
6%
Oedema peripheral
6%
Renal impairment
6%
Abdominal pain
6%
Nausea
6%
Dyspepsia
6%
Alopecia
4%
Arthralgia
4%
Gastroenteritis
4%
Leukopenia
4%
Pneumonia
3%
Vomiting
2%
Acute kidney injury
2%
Pharyngitis
2%
Hypokalaemia
2%
Systemic lupus erythematosus
1%
Pulmonary tuberculosis
1%
Generalised oedema
1%
Gastritis
1%
Cervix carcinoma stage 0
1%
Lung abscess
1%
Pneumonia cytomegaloviral
1%
Lupus nephritis
1%
Cerebral infarction
1%
Lupus encephalitis
1%
Migraine
1%
Neuropsychiatric lupus
1%
Neutropenia
1%
Cardiac failure congestive
1%
Blood lactate dehydrogenase increased
1%
Pleural effusion
1%
Intentional overdose
1%
Abortion induced
1%
Cardiac failure
1%
Cardiac failure acute
1%
Developmental hip dysplasia
1%
Renal failure
1%
Pyelonephritis acute
1%
Acute sinusitis
1%
Bacterial diarrhoea
1%
Cystitis
1%
Hypertensive crisis
1%
Acute coronary syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Oral Capsule
Voclosporin
VOCAL Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Voclosporin treatment group 4Experimental Treatment1 Intervention
Maximum dose of 4 capsules (31.6 mg) BID of voclosporin.
Group II: Voclosporin treatment group 3Experimental Treatment1 Intervention
3 capsules (23.7 mg) BID of voclosporin
Group III: Voclosporin treatment group 1Experimental Treatment1 Intervention
2 capsules (15.8 mg) BID of voclosporin
Group IV: Placebo treatment groupPlacebo Group1 Intervention
2 capsules BID of placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Voclosporin
2022
Completed Phase 3
~980
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
Labcorp Drug Development, Inc.Industry Sponsor
10 Previous Clinical Trials
497 Total Patients Enrolled
Media Library
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.
When will the FDA be able to render a decision on Voclosporin's efficacy?
"There is some evidence from past clinical trials to suggest that Voclosporin is safe for use, so it received a score of 3."
Answered by AI
If I join this study, am I required to take medication or undergo surgery?
"This study is looking for 40 adolescents between the ages of 12 and 17 that have nephritis. Most importantly, potential patients must meet the following requirements: a kidney biopsy that confirm active lupus nephritis and a previous diagnosis of systemic lupus erythematosus according to the 2019 EULAR/ACR classification criteria."
Answered by AI
Are the participants in this research over the age of 30?
"Enrolment for this clinical trial is only possible if the patient is between 12 and 17 years old. Out of the 42 total trials, 9 are specific to this age group while 33 cater to seniors aged 65 and older."
Answered by AI
Are recruitment efforts for this trial ongoing at the moment?
"The clinical trial in question is not, at present, recruiting patients. This is according to the most recent information found on clinicaltrials.gov; the study was first posted on 8/1/2022 and last edited on 6/30/2022. There are other 41 trials currently recruiting candidates."
Answered by AI
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