Focal Segmental GlomerulosclerosisPhase 2AURONA™NCT03598036

Dose-Exploration Evaluating the Efficacy and Safety of Voclosporin in Subjects With Focal Segmental Glomerulosclerosis

A Phase 2 study testing Voclosporin in people with Focal Segmental Glomerulosclerosis, run by Aurinia Pharmaceuticals Inc. at 23 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Evaluating the Efficacy and Safety of Voclosporin in Achieving Complete or Partial Remission of Proteinuria in Subjects with Focal Segmental Glomerulosclerosis Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Focal Segmental Glomerulosclerosis
What is being tested?: Voclosporin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 23 sitesin 2 countries
Study dates: 21 Jun 2018to 19 May 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Primary FSGS diagnosed by renal biopsy.
Urine protein creatinine ratio (UPCR) ≥2.0 mg/mg, serum albumin ≤3.2 g/dL and can be immunosuppressant treatment-naïve, or receiving treatment with steroids.
Stable proteinuria, renal function, and BP.

Who cannot join

Clinical or histologic evidence of secondary FSGS.
Histologic evidence of collapsing variant FSGS.
eGFR as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation of ≤30 mL/minute/1.73 m2 at initial screening assessment or ≤45 mL/minute/1.73 m2 at last qualifying assessment.
Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
Current or medical history of:
Congenital or acquired immunodeficiency.

Show all 11Show fewer

In the opinion of the Investigator, clinically significant drug or alcohol abuse within 2 years prior to screening.
Malignancy within 5 years of screening, with the exception of basal and squamous cell carcinomas treated by complete excision.
Current or past lymphoproliferative disease or previous total lymphoid irradiation.
Severe viral infection within 3 months of screening, or known HIV infection. Severe viral infection is defined as active disease requiring antiviral therapy.
Active tuberculosis (TB) or known history of TB/evidence of old TB if not taking prophylaxis with isoniazid.

Trial locations and contacts

23 sites in 2 countries.

Country

City, postcode or hospital

23 sites in 2 countries

United States21 sites

FSGS Investigative Center
Bethlehem, Pennsylvania, 18017
FSGS Investigative Center
Chapel Hill, North Carolina, 27599-7155
FSGS Investigative Center
Charlotte, North Carolina, 28204
FSGS Investigative Center
Chicago, Illinois, 60611
FSGS Investigative Center
Columbus, Ohio, 43210
FSGS Investigative Center
Dallas, Texas, 75231
FSGS Investigative Center
Dallas, Texas, 75246
FSGS Investigative Center
Denver, Colorado, 80213
FSGS Investigative Center
Detroit, Michigan, 48201
FSGS Investigative Center
El Paso, Texas, 79935
FSGS Investigative Center
Houston, Texas, 77030
FSGS Investigative Center
Iowa City, Iowa, 52242
FSGS Investigative Center
Lawrenceville, Georgia, 30046
FSGS Investigative Center
Louisville, Kentucky, 40202
FSGS Investigative Center
Minneapolis, Minnesota, 55414
FSGS Investigative Center
New York, New York, 10032
FSGS Investigative Center
Newark, New Jersey, 07103
FSGS Investigative Site
Salt Lake City, Utah, 84115
FSGS Investigative Center
Shreveport, Louisiana, 71101
FSGS Investigative Centre
St Louis, Missouri, 63110
FSGS Investigative Center
Winter Park, Florida, 32789

Other trials in United States

Dominican Republic2 sites

FSGS Investigative Centre
Santiago de los Caballeros, 51000
FSGS Investigative Center
Santo Domingo

Other trials in Dominican Republic

About this study

Official title: An Open-Label Dose-Exploration Cohort Study Evaluating the Efficacy and Safety of Voclosporin in Achieving Complete or Partial Remission of Proteinuria in Subjects With Focal Segmental Glomerulosclerosis

Evaluating the Efficacy and Safety of Voclosporin in Achieving Complete or Partial Remission of Proteinuria in Subjects with Focal Segmental Glomerulosclerosis

Read the detailed description

The aim of the current study to assess the efficacy of voclosporin in achieving complete or partial remission of proteinuria after 24 weeks of therapy in subjects with focal segmental glomerulosclerosis (FSGS). As well as to assess the safety and tolerability of voclosporin over 24 weeks in subjects with FSGS.

Conditions: Focal Segmental Glomerulosclerosis
Being tested: Voclosporin
Keywords: calcineurin inhibitors, Focal Segmental Glomerulosclerosis
Medical subject headings: Glomerulosclerosis, Focal Segmental

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VoclosporinDrug
Voclosporin softgel capsules. Up to 10 subjects will be enrolled into Cohort 1 and take up to 3 capsules twice daily (BID).
The dose of voclosporin for Cohort 2 (at least 10 subjects) will be determined by analysis of efficacy and safety data at Week 12 from the first 5 or 6 subjects in Cohort 1.

Study groups in NCT03598036
Study group	Role	What they receive
Voclosporin	Experimental	Cohort 1: Maximum dose of 3 capsules (7.9mg) BID Cohort 2 Dosing to be decided based on the safety from the first 5 or 6 subjects in Cohort 1. Receives: Drug: Voclosporin

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Subjects With Remission of Proteinuria
Complete remission OR Partial remission
Measured: 24 weeks

Secondary outcomes (19)

Proportion of Subjects With Complete Remission or Partial Remission of Proteinuria
Complete remission or partial remission of proteinuria
Measured: Weeks 8 and 12
Proportion of Subjects With Complete Remission of Proteinuria
Complete remission of proteinuria
Measured: Weeks 8, 12, and 24
Proportion of Subjects With Reduction of Proteinuria
Reduction of proteinuria
Measured: Weeks 8, 12, and 24
Proportion of Subjects With Partial Remission of Proteinuria
Partial remission of proteinuria
Measured: Weeks 8, 12, and 24
Time to First Occurrence of Complete or Partial Remission of Proteinuria
Complete OR partial remission of proteinuria
Measured: Up to 26 weeks
Time to First Occurrence of Complete Remission of Proteinuria
Complete remission of proteinuria
Measured: Up to 26 weeks
Time to First Occurrence of Partial Remission of Proteinuria
Partial remission of proteinuria
Measured: Up to 26 weeks
Time to First Occurrence of 50% Reduction in Urine Protein Creatinine Ratio (UPCR) From Baseline
50% reduction in Urine Protein Creatinine Ratio (UPCR) from baseline
Measured: Up to 26 weeks
Duration of Reduced Urine Protein Creatinine Ratio (UPCR)
Duration of reduced Urine Protein Creatinine Ratio (UPCR)
Measured: Up to 26 weeks
Change From Baseline in Urine Protein Creatinine Ratio (UPCR)
Change from baseline in Urine Protein Creatinine Ratio (UPCR)
Measured: Weeks 2,4,8,12,18,24
Proportion of Subjects With a Confirmed Decrease From Baseline in Estimated Glomerular Filtration Rate (eGFR)
Utilizing the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula
Measured: Weeks 2,4,8,12,18,24
Proportion of Subjects With a Confirmed Increase in Estimated Glomerular Filtration Rate (eGFR)
Increase in Estimated Glomerular Filtration Rate (eGFR)
Measured: Week 24 to Week 26
Change in Urine Protein Creatinine Ratio (UPCR)
Change in Urine Protein Creatinine Ratio (UPCR)
Measured: Week 24 and Week 26
Change in Estimated Glomerular Filtration Rate (eGFR)
Change in estimated Glomerular Filtration Rate (eGFR)
Measured: Week 24 and Week 26
Change From Baseline in Serum Creatinine, Serum Albumin and Estimate Glomerular Filtration Rate (eGFR)
Change from baseline in serum creatinine, serum albumin and estimate Glomerular Filtration Rate (eGFR)
Measured: Weeks 2,4,8,12,18,24
Quality of Life Assessments
Mean change in Patient Reported Outcome Measurement Information System (PROMIS) measures
Measured: Week 24
Quality of Life Assessments
Change from baseline in Kidney Disease Quality of Life-Short Form (KDQOL-SF)
Measured: Week 24
Safety and Tolerability (Treatment-Emergent Adverse Events)
Incidence and number of treatment-emergent adverse events
Measured: 24 weeks
Renal Biopsy
Descriptive analyses of changes in histopathology will be evaluated in post treatment renal biopsies in a subset of patients
Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jun 201819 May 2020

First posted26 Jul 2018
Study start21 Jun 2018
Primary completion19 May 2020
Study completion19 May 2020

Why it stopped: Low recruitment rate

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Focal Segmental GlomerulosclerosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03598036
Sponsor's protocol ID: AUR-VCS-2017-03
Acronym: AURONA™
Status last verified: Jun 2020
First submitted: 14 Jun 2018
Last updated: 16 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Ling SY, Huizinga RB, Mayo PR, Larouche R, Freitag DG, Aspeslet LJ, Foster RT. Cytochrome P450 3A and P-glycoprotein drug-drug interactions with voclosporin. Br J Clin Pharmacol. 2014 Jun;77(6):1039-50. doi: 10.1111/bcp.12309.
PubMed 24330024
Ling SY, Huizinga RB, Mayo PR, Freitag DG, Aspeslet LJ, Foster RT. Pharmacokinetics of voclosporin in renal impairment and hepatic impairment. J Clin Pharmacol. 2013 Dec;53(12):1303-12. doi: 10.1002/jcph.166. Epub 2013 Oct 8.
PubMed 23996158
Mayo PR, Huizinga RB, Ling SY, Freitag DG, Aspeslet LJ, Foster RT. Voclosporin food effect and single oral ascending dose pharmacokinetic and pharmacodynamic studies in healthy human subjects. J Clin Pharmacol. 2013 Aug;53(8):819-26. doi: 10.1002/jcph.114. Epub 2013 Jun 4.
PubMed 23736966
Busque S, Cantarovich M, Mulgaonkar S, Gaston R, Gaber AO, Mayo PR, Ling S, Huizinga RB, Meier-Kriesche HU; PROMISE Investigators. The PROMISE study: a phase 2b multicenter study of voclosporin (ISA247) versus tacrolimus in de novo kidney transplantation. Am J Transplant. 2011 Dec;11(12):2675-84. doi: 10.1111/j.1600-6143.2011.03763.x. Epub 2011 Sep 22.
PubMed 21943027

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Focal Segmental Glomerulosclerosis trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Dose-Exploration Cohort Study Evaluating the Efficacy and Safety of Voclosporin in Achieving Complete or Partial Remission of Proteinuria in Subjects With Focal Segmental Glomerulosclerosis
ClinicalTrials.gov ID: NCT03598036
Acronym / sponsor ID: AURONA™ / AUR-VCS-2017-03
Conditions: Focal Segmental Glomerulosclerosis
Keywords: calcineurin inhibitors, Focal Segmental Glomerulosclerosis
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Low recruitment rate
Enrolment: 5 participants (actual)
Lead sponsor: Aurinia Pharmaceuticals Inc.Industry (pharma, biotech, devices)
Study start: 21 Jun 2018 (actual)
Primary completion: 19 May 2020 (actual)
Study completion: 19 May 2020 (actual)
First posted: 26 Jul 2018 (actual)
Results: Posted 16 Sep 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Evaluating the Efficacy and Safety of Voclosporin in Achieving Complete or Partial Remission of Proteinuria in Subjects with Focal Segmental Glomerulosclerosis

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Voclosporin	Experimental	Drug: VoclosporinCohort 1: Maximum dose of 3 capsules (7.9mg) BID Cohort 2 Dosing to be decided based on the safety from the first 5 or 6 subjects in Cohort 1.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Primary FSGS diagnosed by renal biopsy.
Urine protein creatinine ratio (UPCR) ≥2.0 mg/mg, serum albumin ≤3.2 g/dL and can be immunosuppressant treatment-naïve, or receiving treatment with steroids.
Stable proteinuria, renal function, and BP.

Key exclusion criteria (11 listed)

Clinical or histologic evidence of secondary FSGS.
Histologic evidence of collapsing variant FSGS.
eGFR as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation of ≤30 mL/minute/1.73 m2 at initial screening assessment or ≤45 mL/minute/1.73 m2 at last qualifying assessment.
Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
Current or medical history of:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VoclosporinVoclosporin softgel capsules. Up to 10 subjects will be enrolled into Cohort 1 and take up to 3 capsules twice daily (BID). The dose of voclosporin for Cohort 2 (at least 10 subjects) will be determined by analysis of efficacy and safety data at Week 12 from the first 5 or 6 subjects in Cohort 1.	Drug	Voclosporin

Primary outcome

Proportion of Subjects With Remission of Proteinuria
Time frame: 24 weeks
Complete remission OR Partial remission

19 secondary outcomes

Proportion of Subjects With Complete Remission or Partial Remission of Proteinuria
Time frame: Weeks 8 and 12
Proportion of Subjects With Complete Remission of Proteinuria
Time frame: Weeks 8, 12, and 24
Proportion of Subjects With Reduction of Proteinuria
Time frame: Weeks 8, 12, and 24
Proportion of Subjects With Partial Remission of Proteinuria
Time frame: Weeks 8, 12, and 24
Time to First Occurrence of Complete or Partial Remission of Proteinuria
Time frame: Up to 26 weeks
Time to First Occurrence of Complete Remission of Proteinuria
Time frame: Up to 26 weeks
Time to First Occurrence of Partial Remission of Proteinuria
Time frame: Up to 26 weeks
Time to First Occurrence of 50% Reduction in Urine Protein Creatinine Ratio (UPCR) From Baseline
Time frame: Up to 26 weeks
Duration of Reduced Urine Protein Creatinine Ratio (UPCR)
Time frame: Up to 26 weeks
Change From Baseline in Urine Protein Creatinine Ratio (UPCR)
Time frame: Weeks 2,4,8,12,18,24
Proportion of Subjects With a Confirmed Decrease From Baseline in Estimated Glomerular Filtration Rate (eGFR)
Time frame: Weeks 2,4,8,12,18,24
Proportion of Subjects With a Confirmed Increase in Estimated Glomerular Filtration Rate (eGFR)
Time frame: Week 24 to Week 26
Change in Urine Protein Creatinine Ratio (UPCR)
Time frame: Week 24 and Week 26
Change in Estimated Glomerular Filtration Rate (eGFR)
Time frame: Week 24 and Week 26
Change From Baseline in Serum Creatinine, Serum Albumin and Estimate Glomerular Filtration Rate (eGFR)
Time frame: Weeks 2,4,8,12,18,24
Quality of Life Assessments
Time frame: Week 24
Quality of Life Assessments
Time frame: Week 24
Safety and Tolerability (Treatment-Emergent Adverse Events)
Time frame: 24 weeks
Renal Biopsy
Time frame: 24 weeks

Results and safety

Results posted to the registry on 16 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Voclosporin Cohort 1	5	4
Voclosporin Cohort 2	0	0

Primary outcome: Proportion of Subjects With Remission of Proteinuria

Time frame: 24 weeks

Population analysed: 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

19 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 to Week 26. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Voclosporin Cohort 1: Week 1	0 of 5 (0%)	2 of 5 (40%)	0 of 5
Voclosporin Cohort 1: Week 2	0 of 5 (0%)	0 of 5 (0%)	0 of 5
Voclosporin Cohort 1: Weeks 3-24	1 of 5 (20%)	5 of 5 (100%)	0 of 5
Voclosporin Cohort 2	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24330024Ling SY, Huizinga RB, Mayo PR, Larouche R, Freitag DG, Aspeslet LJ, Foster RT. Cytochrome P450 3A and P-glycoprotein drug-drug interactions with voclosporin. Br J Clin Pharmacol. 2014 Jun;77(6):1039-50. doi: 10.1111/bcp.12309.
Background: PubMed 23996158Ling SY, Huizinga RB, Mayo PR, Freitag DG, Aspeslet LJ, Foster RT. Pharmacokinetics of voclosporin in renal impairment and hepatic impairment. J Clin Pharmacol. 2013 Dec;53(12):1303-12. doi: 10.1002/jcph.166. Epub 2013 Oct 8.
Background: PubMed 23736966Mayo PR, Huizinga RB, Ling SY, Freitag DG, Aspeslet LJ, Foster RT. Voclosporin food effect and single oral ascending dose pharmacokinetic and pharmacodynamic studies in healthy human subjects. J Clin Pharmacol. 2013 Aug;53(8):819-26. doi: 10.1002/jcph.114. Epub 2013 Jun 4.
Background: PubMed 21943027Busque S, Cantarovich M, Mulgaonkar S, Gaston R, Gaber AO, Mayo PR, Ling S, Huizinga RB, Meier-Kriesche HU; PROMISE Investigators. The PROMISE study: a phase 2b multicenter study of voclosporin (ISA247) versus tacrolimus in de novo kidney transplantation. Am J Transplant. 2011 Dec;11(12):2675-84. doi: 10.1111/j.1600-6143.2011.03763.x. Epub 2011 Sep 22.
Individual participant dataSharing planned: No

Related trials for Focal Segmental Glomerulosclerosis

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

23 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Voclosporin in people with Focal Segmental Glomerulosclerosis, run by Aurinia Pharmaceuticals Inc. at 23 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States, Dominican Republic. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Subjects With Remission of Proteinuria (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03598036, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.