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Lupus NephritisPhase 2AURIONNCT02949973

Aurinia Early Urinary Protein Reduction Predicts Response

A Phase 2 study testing voclosporin in people with Lupus Nephritis, run by Aurinia Pharmaceuticals Inc. at 2 sites in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

An exploratory study assessing the ability of biomarkers measured at 8 weeks to predict clinical response over 24 and 48 weeks in subjects taking voclosporin 23.7 mg twice daily (BID) in combination with standard of care in patients with active lupus nephritis Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Lupus Nephritis
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
10 participants
Where
2 sitesMalaysia
Study dates
Jun 2015to 17 Feb 2017
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

  • Diagnosis of systemic lupus erythematosus (SLE) according to the American College of Rheumatology criteria (1997; see Appendix 6).
  • Kidney biopsy within 24 months prior to screening with a histologic diagnosis of lupus nephritis International Society of Nephrology/Renal Pathology Society Classes III, IV-S or IV-G, (A) or (A/C); or Class V, alone or in combination with Class III or IV.
  • Laboratory evidence of active nephritis at screening, defined as: Class III, IV-S or Class IV-G (proteinuria ≥1000 mg/24 hours when assessed by 24 hour urine collection, defined by a urine protein/creatinine ratio (UPCR) of ≥1.0 mg/mg assessed in a first morning void urine specimen). Class V, alone or in combination with Class III or IV, (proteinuria ≥1,500 mg/24 hours when assessed by 24 hour urine collection, defined by a UPCR of ≥1.5 mg/mg assessed in a first morning void urine specimen).

Who cannot join

  • Estimated glomerular filtration rate (eGFR) as calculated by the Chronic Kidney Disease Epidemiology Collaboration equation of ≤45 mL/min/1.73 m2 at screening
  • Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
  • A previous kidney transplant or planned transplant within study treatment period.
  • Malignancy within 5 years of screening, with the exception of basal and squamous cell carcinomas treated by complete excision. Subjects with cervical dysplasia that is cervical intraepithelial neoplasia 1, but have been treated with conization or loop electrosurgical excision procedure, and have had a normal repeat Papanicolaou smear test (PAP) are allowed.
  • Lymphoproliferative disease or previous total lymphoid irradiation.
  • Severe viral infection (such as Cytomegalovirus (CMV), Hepatitis B virus (HBV), Hepatitis C virus (HCV)) within 3 months of screening; or known human immunodeficiency virus infection.
Show all 14Show fewer
  • Active tuberculosis (TB), or known history of TB/evidence of old TB if not taking prophylaxis with isoniazid.
  • Other known clinically significant active medical conditions, such as:
  • Severe cardiovascular disease including congestive heart failure, history of cardiac dysrhythmia or congenital long QT syndrome. QT interval duration corrected for heart rate using method of Fridericia (QTcF) exceeding 480 msec in the presence of a normal QRS interval (<110 msec) at time of screening will result in exclusion.
  • Liver dysfunction (aspartate aminotransferase, alanine aminotransferase, or bilirubin greater than 2.5 times the upper limit of normal) at screening and confirmed before enrollment.
  • Chronic obstructive pulmonary disease or asthma requiring oral steroids.
  • Bone marrow insufficiency unrelated to active systemic lupus erythematosus (SLE) (according to Investigator judgment) with white blood cell count <2,500/mm3; absolute neutrophil count <1.3 × 103/μL; thrombocytopenia (platelet count <50,000/mm3).
  • Active bleeding disorders.
  • Current infection requiring IV antibiotics.

Trial locations and contacts

2 sites in 1 country.

Malaysia2 sites

  • AURION Site

    Kuala Lumpur, 50586

  • AURION Site

    Kuala Lumpur, 56000

Other trials in Malaysia

About this study

Official title: An Exploratory Study Assessing the Short Term Predictors of Remission of Voclosporin 23.7mg Twice Daily (BID) in Combination With Standard of Care in Patients With Active Lupus Nephritis

An exploratory study assessing the ability of biomarkers measured at 8 weeks to predict clinical response over 24 and 48 weeks in subjects taking voclosporin 23.7 mg twice daily (BID) in combination with standard of care in patients with active lupus nephritis

Read the detailed description

Voclosporin is a novel calcineurin inhibitor (CNI) intended for use in the prevention of organ graft rejection and for the treatment of autoimmune diseases. The aim of the current development program is to investigate whether voclosporin added to the standard of care treatment in active Lupus Nephritis (LN) is able to reduce disease activity, as measured by a reduction in proteinuria. The background therapy will be mycophenolate mofetil (MMF) 2 g daily, initial treatment with IV methylprednisolone followed by a reducing course of oral corticosteroids. Patients with active, flaring LN will be eligible to enter the study. They are required to have a diagnosis of LN according to established diagnostic criteria (American College of Rheumatology) and clinical and biopsy features suggestive of active nephritis. Efficacy will be assessed by the ability of the drug combination to reduce the level of proteinuria while demonstrating an acceptable safety profile.

Conditions
Lupus Nephritis
Being tested
voclosporin
Keywords
lupus nephritis, calcineurin inhibitors, voclosporin
Medical subject headings
Lupus Nephritis

What participants receive

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

  • voclosporinDrug

    Also called ISA247

Study groups in NCT02949973
Study groupRoleWhat they receive
VoclosporinExperimentalVoclosporin, oral, 23.7 mg twice daily (BID)
Receives: Drug: voclosporin

What is being measured

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

  1. Number of Participants With Reduction or Normalization of Urine Protein/Creatinine Ratio (UPCR)

    Measured: 24 weeks

  2. Number of Participants With Reduction or Normalization of Anti ds DNA

    Measured: 24 weeks

  3. Number of Participants With Reduction or Normalization of C3

    Measured: 24 weeks

  4. Number of Participants With Reduction or Normalization of C4

    Measured: 24 weeks

Secondary outcomes (2)

  1. Number of Participants With Complete Remission at Week 24

    • Confirmed Protein/creatinine ratio of ≤0.5 mg/mg and
    • eGFR ≥ 60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of ≥20%

    Measured: week 24

  2. Number of Participants With Complete Remission at Week 48

    • Confirmed Protein/creatinine ratio of ≤0.5 mg/mg and
    • eGFR ≥ 60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of ≥20%

    Safety Population - 2 subjects failed to provide sufficient data to ascertain week 48 response

    Measured: week 48

Timeline

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

  1. First posted31 Oct 2016 (estimated)
  2. Study startJun 2015
  3. Primary completionDec 2016
  4. Study completion17 Feb 2017

Resources

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
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02949973
Sponsor's protocol ID
AUR-VCS-2014-01
Acronym
AURION
Status last verified
Mar 2021
First submitted
26 Oct 2016
Last updated
19 Mar 2021
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing voclosporin in people with Lupus Nephritis, run by Aurinia Pharmaceuticals Inc. at 2 sites in Malaysia.

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 14 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: finished, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Malaysia. 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 19 Mar 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?

Number of Participants With Reduction or Normalization of Urine Protein/Creatinine Ratio (UPCR) (time frame: 24 weeks). The study lists 4 primary outcomes in all. 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 NCT02949973.

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 19 Mar 2021; AzTrials last refreshed its copy on 27 Oct 2026.

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