Dose-Exploration Evaluating the Efficacy and Safety of Voclosporin in Subjects With Focal Segmental Glomerulosclerosis
NCT ID: NCT03598036
Last Updated: 2021-09-16
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
5 participants
INTERVENTIONAL
2018-06-21
2020-05-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Aurinia Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Locations
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FSGS Investigative Center
Denver, Colorado, United States
FSGS Investigative Center
Winter Park, Florida, United States
FSGS Investigative Center
Lawrenceville, Georgia, United States
FSGS Investigative Center
Chicago, Illinois, United States
FSGS Investigative Center
Iowa City, Iowa, United States
FSGS Investigative Center
Louisville, Kentucky, United States
FSGS Investigative Center
Shreveport, Louisiana, United States
FSGS Investigative Center
Detroit, Michigan, United States
FSGS Investigative Center
Minneapolis, Minnesota, United States
FSGS Investigative Centre
St Louis, Missouri, United States
FSGS Investigative Center
Newark, New Jersey, United States
FSGS Investigative Center
New York, New York, United States
FSGS Investigative Center
Chapel Hill, North Carolina, United States
FSGS Investigative Center
Charlotte, North Carolina, United States
FSGS Investigative Center
Columbus, Ohio, United States
FSGS Investigative Center
Bethlehem, Pennsylvania, United States
FSGS Investigative Center
Dallas, Texas, United States
FSGS Investigative Center
Dallas, Texas, United States
FSGS Investigative Center
El Paso, Texas, United States
FSGS Investigative Center
Houston, Texas, United States
FSGS Investigative Site
Salt Lake City, Utah, United States
FSGS Investigative Centre
Santiago de los Caballeros, , Dominican Republic
FSGS Investigative Center
Santo Domingo, , Dominican Republic
Countries
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References
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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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan: Protocol v1.0
Document Type: Study Protocol and Statistical Analysis Plan: Protocol v2.0 (Amendment 1)
Document Type: Study Protocol and Statistical Analysis Plan: Protocol v3.0 (Amendment 2)
Document Type: Study Protocol and Statistical Analysis Plan: Protocol v4.0 (Amendment 3)
Other Identifiers
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AUR-VCS-2017-03
Identifier Type: -
Identifier Source: org_study_id
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