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Trial record 1 of 1 for:    aurion
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Aurinia Early Urinary Protein Reduction Predicts Response (AURION)

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ClinicalTrials.gov Identifier: NCT02949973
Recruitment Status : Completed
First Posted : October 31, 2016
Last Update Posted : September 20, 2017
Sponsor:
Information provided by (Responsible Party):
Aurinia Pharmaceuticals Inc.

Brief 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 BID in combination with standard of care in patients with active lupus nephritis

Condition or disease Intervention/treatment Phase
Lupus Nephritis Drug: voclosporin Phase 2

Detailed Description:
Voclosporin is a next generation 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 LN is able to reduce disease activity, as measured by a reduction in proteinuria.The background therapy will be 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Exploratory Study Assessing the Short Term Predictors of Remission of Voclosporin 23.7mg BID in Combination With Standard of Care in Patients With Active Lupus Nephritis
Study Start Date : June 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : February 17, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Voclosporin
Voclosporin, oral, 23.7 mg BID
Drug: voclosporin
Other Name: ISA247




Primary Outcome Measures :
  1. Number of patients achieving identified biomarkers and the number of these patients who go on to achieve week 24 complete remission. [ Time Frame: 24 weeks ]
    Complete remission is defined as Protein/creatinine ratio of ≤0.5 mg/mg in the presence of stable renal function


Secondary Outcome Measures :
  1. The number of subjects achieving complete remission at 24 weeks. [ Time Frame: 24 weeks ]
  2. Number of patients achieving identified biomarkers and the number of these patients who go on to achieve week 48 complete remission. [ Time Frame: 48 weeks ]
    Complete remission is defined as Protein/creatinine ratio of ≤0.5 mg/mg in the presence of stable renal function



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • 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 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).

Key Exclusion Criteria:

  • 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 PAP are allowed.
  • Lymphoproliferative disease or previous total lymphoid irradiation.
  • Severe viral infection (such as CMV, HBV, HCV) within 3 months of screening; or known human immunodeficiency virus infection.
  • 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. QTcF (QT interval duration corrected for heart rate using method of Fridericia) 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02949973


Locations
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Malaysia
AURION Site
Kuala Lumpur, Malaysia, 50586
AURION Site
Kuala Lumpur, Malaysia, 56000
Sponsors and Collaborators
Aurinia Pharmaceuticals Inc.
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Responsible Party: Aurinia Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT02949973    
Other Study ID Numbers: AUR-VCS-2014-01
First Posted: October 31, 2016    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Aurinia Pharmaceuticals Inc.:
lupus nephritis
calcineurin inhibitors
voclosporin
Additional relevant MeSH terms:
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Nephritis
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases