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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03598036
Recruitment Status : Terminated (Low recruitment rate)
First Posted : July 26, 2018
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
Aurinia Pharmaceuticals Inc.

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

Condition or disease Intervention/treatment Phase
Focal Segmental Glomerulosclerosis Drug: Voclosporin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 21, 2018
Actual Primary Completion Date : May 19, 2020
Actual Study Completion Date : May 19, 2020


Arm Intervention/treatment
Experimental: Voclosporin

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.

Drug: Voclosporin

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.





Primary Outcome Measures :
  1. Proportion of subjects with remission of proteinuria [ Time Frame: 24 weeks ]
    Complete remission OR Partial remission


Secondary Outcome Measures :
  1. Proportion of subjects with complete remission or partial remission of proteinuria [ Time Frame: Weeks 8 and 12 ]
    Complete remission or partial remission of proteinuria

  2. Proportion of subjects with complete remission of proteinuria [ Time Frame: Weeks 8, 12, and 24 ]
    Complete remission of proteinuria

  3. Proportion of subjects with reduction of proteinuria [ Time Frame: Weeks 8, 12, and 24 ]
    Reduction of proteinuria

  4. Proportion of subjects with partial remission of proteinuria [ Time Frame: Weeks 8, 12, and 24 ]
    Partial remission of proteinuria

  5. Time to first occurrence of complete or partial remission of proteinuria [ Time Frame: Up to 26 weeks ]
    Complete OR partial remission of proteinuria

  6. Time to first occurrence of complete remission of proteinuria [ Time Frame: Up to 26 weeks ]
    Complete remission of proteinuria

  7. Time to first occurrence of partial remission of proteinuria [ Time Frame: Up to 26 weeks ]
    Partial remission of proteinuria

  8. Time to first occurrence of 50% reduction in UPCR from baseline [ Time Frame: Up to 26 weeks ]
    50% reduction in UPCR from baseline

  9. Duration of reduced UPCR [ Time Frame: Up to 26 weeks ]
    Duration of reduced UPCR

  10. Change from baseline in UPCR [ Time Frame: Week, 2,4,8,12,18,24 ]
    Change from baseline in UPCR

  11. Proportion of subjects with a confirmed decrease from baseline in eGFR [ Time Frame: Week, 2,4,8,12,18,24 ]
    Utilizing the CKD-EPI formula

  12. Proportion of subjects with a confirmed increase in eGFR [ Time Frame: Final Visit (week 24) to second Safety Follow-up visit (Visit 10) ]
    Increase in eGFR

  13. Change in UPCR [ Time Frame: Week 24 and 26 ]
    Change in UPCR

  14. Change in eGFR [ Time Frame: Week 24 and 26 ]
    Change in eGFR

  15. Change from baseline in serum creatinine, serum albumin, and eGFR [ Time Frame: Week, 2,4,8,12,18,24 ]
    Change from baseline in serum creatinine, serum albumin, and eGFR

  16. Quality of life assessments [ Time Frame: Week 24 ]
    Mean change in Patient Reported Outcome Measurement Information System (PROMIS) measures

  17. Quality of life assessments [ Time Frame: Week 24 ]
    Change from baseline in Kidney Disease Quality of Life-Short Form (KDQOL-SF)

  18. Safety and tolerability (treatment-emergent adverse events) [ Time Frame: 24 weeks ]
    Incidence and number of treatment-emergent adverse events

  19. Renal biopsy [ Time Frame: 24 weeks ]
    Descriptive analyses of changes in histopathology will be evaluated in post treatment renal biopsies in a subset of patients



Information from the National Library of Medicine

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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

Inclusion Criteria:

  1. Primary FSGS diagnosed by renal biopsy.
  2. 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.
  3. Stable proteinuria, renal function, and BP.

Exclusion Criteria:

  1. Clinical or histologic evidence of secondary FSGS.
  2. Histologic evidence of collapsing variant FSGS.
  3. 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.
  4. Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
  5. Current or medical history of:

    • Congenital or acquired immunodeficiency.
    • 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.

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): NCT03598036


Locations
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United States, Colorado
FSGS Investigative Center
Denver, Colorado, United States, 80213
United States, Florida
FSGS Investigative Center
Winter Park, Florida, United States, 32789
United States, Georgia
FSGS Investigative Center
Lawrenceville, Georgia, United States, 30046
United States, Illinois
FSGS Investigative Center
Chicago, Illinois, United States, 60611
United States, Iowa
FSGS Investigative Center
Iowa City, Iowa, United States, 52242
United States, Kentucky
FSGS Investigative Center
Louisville, Kentucky, United States, 40202
United States, Louisiana
FSGS Investigative Center
Shreveport, Louisiana, United States, 71101
United States, Michigan
FSGS Investigative Center
Detroit, Michigan, United States, 48201
United States, Minnesota
FSGS Investigative Center
Minneapolis, Minnesota, United States, 55414
United States, Missouri
FSGS Investigative Centre
Saint Louis, Missouri, United States, 63110
United States, New Jersey
FSGS Investigative Center
Newark, New Jersey, United States, 07103
United States, New York
FSGS Investigative Center
New York, New York, United States, 10032
United States, North Carolina
FSGS Investigative Center
Chapel Hill, North Carolina, United States, 27599-7155
FSGS Investigative Center
Charlotte, North Carolina, United States, 28204
United States, Ohio
FSGS Investigative Center
Columbus, Ohio, United States, 43210
United States, Pennsylvania
FSGS Investigative Center
Bethlehem, Pennsylvania, United States, 18017
United States, Texas
FSGS Investigative Center
Dallas, Texas, United States, 75231
FSGS Investigative Center
Dallas, Texas, United States, 75246
FSGS Investigative Center
El Paso, Texas, United States, 79935
FSGS Investigative Center
Houston, Texas, United States, 77030
United States, Utah
FSGS Investigative Site
Salt Lake City, Utah, United States, 84115
Dominican Republic
FSGS Investigative Centre
Santiago De Los Caballeros, Dominican Republic, 51000
FSGS Investigative Center
Santo Domingo, Dominican Republic
Sponsors and Collaborators
Aurinia Pharmaceuticals Inc.
Publications:
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Responsible Party: Aurinia Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03598036    
Other Study ID Numbers: AUR-VCS-2017-03
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aurinia Pharmaceuticals Inc.:
calcineurin inhibitors
Focal Segmental Glomerulosclerosis
Additional relevant MeSH terms:
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Glomerulosclerosis, Focal Segmental
Glomerulonephritis
Nephritis
Kidney Diseases
Urologic Diseases