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

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ClinicalTrials.gov Identifier: NCT03598036
Recruitment Status : Recruiting
First Posted : July 25, 2018
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Aurinia Pharmaceuticals Inc.

Tracking Information
First Submitted Date  ICMJE June 14, 2018
First Posted Date  ICMJE July 25, 2018
Last Update Posted Date July 23, 2019
Actual Study Start Date  ICMJE June 21, 2018
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2018)
Proportion of subjects with remission of proteinuria [ Time Frame: 24 weeks ]
Complete remission OR Partial remission
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03598036 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2018)
  • Proportion of subjects with complete remission or partial remission of proteinuria [ Time Frame: Weeks 8 and 12 ]
    Complete remission or partial remission of proteinuria
  • Proportion of subjects with complete remission of proteinuria [ Time Frame: Weeks 8, 12, and 24 ]
    Complete remission of proteinuria
  • Proportion of subjects with reduction of proteinuria [ Time Frame: Weeks 8, 12, and 24 ]
    Reduction of proteinuria
  • Proportion of subjects with partial remission of proteinuria [ Time Frame: Weeks 8, 12, and 24 ]
    Partial remission of proteinuria
  • Time to first occurrence of complete or partial remission of proteinuria [ Time Frame: Up to 26 weeks ]
    Complete OR partial remission of proteinuria
  • Time to first occurrence of complete remission of proteinuria [ Time Frame: Up to 26 weeks ]
    Complete remission of proteinuria
  • Time to first occurrence of partial remission of proteinuria [ Time Frame: Up to 26 weeks ]
    Partial remission of proteinuria
  • Time to first occurrence of 50% reduction in UPCR from baseline [ Time Frame: Up to 26 weeks ]
    50% reduction in UPCR from baseline
  • Duration of reduced UPCR [ Time Frame: Up to 26 weeks ]
    Duration of reduced UPCR
  • Change from baseline in UPCR [ Time Frame: Week, 2,4,8,12,18,24 ]
    Change from baseline in UPCR
  • 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
  • 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
  • Change in UPCR [ Time Frame: Week 24 and 26 ]
    Change in UPCR
  • Change in eGFR [ Time Frame: Week 24 and 26 ]
    Change in eGFR
  • 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
  • Quality of life assessments [ Time Frame: Week 24 ]
    Mean change in Patient Reported Outcome Measurement Information System (PROMIS) measures
  • Quality of life assessments [ Time Frame: Week 24 ]
    Change from baseline in Kidney Disease Quality of Life-Short Form (KDQOL-SF)
  • Safety and tolerability (treatment-emergent adverse events) [ Time Frame: 24 weeks ]
    Incidence and number of treatment-emergent adverse events
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose-Exploration Evaluating the Efficacy and Safety of Voclosporin in Subjects With Focal Segmental Glomerulosclerosis
Official Title  ICMJE 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
Brief Summary Evaluating the Efficacy and Safety of Voclosporin in Achieving Complete or Partial Remission of Proteinuria in Subjects with Focal Segmental Glomerulosclerosis
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Focal Segmental Glomerulosclerosis
Intervention  ICMJE Drug: Voclosporin

Voclosporin softgel capsules. Approximately 10 subjects will be enrolled into Cohort 1 and take up to 3 capsules twice daily (BID).

The dose of voclosporin for Cohort 2 (approximately 10 subjects) will be determined by analysis of efficacy and safety data at Week 12 from the first 6 subjects in Cohort 1.

Study Arms  ICMJE 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 6 subjects in Cohort 1.

Intervention: Drug: Voclosporin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 24, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Primary FSGS diagnosed by renal biopsy within 6 months prior to end of screening.
  2. At initial screening assessment and at last qualifying assessment during screening period prior to baseline, FSGS subjects must have urine protein creatinine ratio (UPCR) ≥2.0 mg/mg, serum albumin ≥3.2 g/dL. Subjects can be treatment-naïve or receiving steroid treatment (oral or IV) for FSGS. Subjects taking steroids must show signs of improvement in proteinuria, defined as at least a 20% improvement in UPCR from initiation of steroids to the last stability assessment prior to baseline. Subjects who have discontinued steroid treatment due to poor tolerability may be considered for the study.
  3. Stable proteinuria, renal function, and BP for at least 2 weeks prior to baseline, as assessed by the Investigator. Substantial changes in UPCR, estimated glomerular filtration rate (eGFR), and/or BP during the screening period may be due to treatments administered (e.g., ACEIs and ARBs); and, therefore, may interfere with study assessments or outcomes, or may place the subject at increased risk. These subjects must be discussed with the medical monitor prior to initiation of study treatment.

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 during screening period prior to baseline.
  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. 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 test are allowed.
    • Current or past lymphoproliferative disease or previous total lymphoid irradiation.
    • Severe viral infection (e.g., cytomegalovirus, hepatitis B virus, hepatitis C virus) 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Laura Lisk (44)1 753 852132 llisk@auriniapharma.com
Contact: Krista Piper (1)778 788 5577 kpiper@auriniapharma.com
Listed Location Countries  ICMJE Dominican Republic,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03598036
Other Study ID Numbers  ICMJE AUR-VCS-2017-03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Aurinia Pharmaceuticals Inc.
Study Sponsor  ICMJE Aurinia Pharmaceuticals Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Aurinia Pharmaceuticals Inc.
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP