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Low recruitment rate
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Evaluating the Efficacy and Safety of Voclosporin in Achieving Complete or Partial Remission of Proteinuria in Subjects with Focal Segmental Glomerulosclerosis
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Voclosporin | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Voclosporin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With Remission of Proteinuria | Complete remission OR Partial remission | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With Complete Remission or Partial Remission of Proteinuria | Complete remission or partial remission of proteinuria | Weeks 8 and 12 |
| Proportion of Subjects With Complete Remission of Proteinuria |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Clinical or histologic evidence of secondary FSGS.
Histologic evidence of collapsing variant FSGS.
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.
Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
Current or medical history of:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FSGS Investigative Center | Denver | Colorado | 80213 | United States | ||
| FSGS Investigative Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24330024 | Background | 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. | |
| 23996158 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Voclosporin Cohort 1 | Cohort 1: Maximum dose of 3 capsules voclosporin (23.7 mg total) twice daily |
| FG001 | Voclosporin Cohort 2 | Trial ended prematurely before any patients were enrolled into Cohort 2 Cohort 2: When Cohort 1 have completed 12 weeks of treatment with voclosporin, the top line efficacy and safety data will be analyzed to determine the dose level for Cohort 2. The selected dose may be higher or lower than 23.7 mg twice daily. The maximum dose possible for Cohort 2 will be 39.5 mg (5 capsules) twice daily. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Protocol v1.0 | Apr 27, 2018 |
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|
Complete remission of proteinuria
| Weeks 8, 12, and 24 |
| Proportion of Subjects With Reduction of Proteinuria | Reduction of proteinuria | Weeks 8, 12, and 24 |
| Proportion of Subjects With Partial Remission of Proteinuria | Partial remission of proteinuria | Weeks 8, 12, and 24 |
| Time to First Occurrence of Complete or Partial Remission of Proteinuria | Complete OR partial remission of proteinuria | Up to 26 weeks |
| Time to First Occurrence of Complete Remission of Proteinuria | Complete remission of proteinuria | Up to 26 weeks |
| Time to First Occurrence of Partial Remission of Proteinuria | Partial remission of proteinuria | Up to 26 weeks |
| Time to First Occurrence of 50% Reduction in Urine Protein Creatinine Ratio (UPCR) From Baseline | 50% reduction in Urine Protein Creatinine Ratio (UPCR) from baseline | Up to 26 weeks |
| Duration of Reduced Urine Protein Creatinine Ratio (UPCR) | Duration of reduced Urine Protein Creatinine Ratio (UPCR) | Up to 26 weeks |
| Change From Baseline in Urine Protein Creatinine Ratio (UPCR) | Change from baseline in Urine Protein Creatinine Ratio (UPCR) | Weeks 2,4,8,12,18,24 |
| Proportion of Subjects With a Confirmed Decrease From Baseline in Estimated Glomerular Filtration Rate (eGFR) | Utilizing the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula | Weeks 2,4,8,12,18,24 |
| Proportion of Subjects With a Confirmed Increase in Estimated Glomerular Filtration Rate (eGFR) | Increase in Estimated Glomerular Filtration Rate (eGFR) | Week 24 to Week 26 |
| Change in Urine Protein Creatinine Ratio (UPCR) | Change in Urine Protein Creatinine Ratio (UPCR) | Week 24 and Week 26 |
| Change in Estimated Glomerular Filtration Rate (eGFR) | Change in estimated Glomerular Filtration Rate (eGFR) | Week 24 and Week 26 |
| Change From Baseline in Serum Creatinine, Serum Albumin and Estimate Glomerular Filtration Rate (eGFR) | Change from baseline in serum creatinine, serum albumin and estimate Glomerular Filtration Rate (eGFR) | Weeks 2,4,8,12,18,24 |
| Quality of Life Assessments | Mean change in Patient Reported Outcome Measurement Information System (PROMIS) measures | Week 24 |
| Quality of Life Assessments | Change from baseline in Kidney Disease Quality of Life-Short Form (KDQOL-SF) | Week 24 |
| Safety and Tolerability (Treatment-Emergent Adverse Events) | Incidence and number of treatment-emergent adverse events | 24 weeks |
| Renal Biopsy | Descriptive analyses of changes in histopathology will be evaluated in post treatment renal biopsies in a subset of patients | 24 weeks |
| Winter Park |
| Florida |
| 32789 |
| United States |
| FSGS Investigative Center | Lawrenceville | Georgia | 30046 | United States |
| FSGS Investigative Center | Chicago | Illinois | 60611 | United States |
| FSGS Investigative Center | Iowa City | Iowa | 52242 | United States |
| FSGS Investigative Center | Louisville | Kentucky | 40202 | United States |
| FSGS Investigative Center | Shreveport | Louisiana | 71101 | United States |
| FSGS Investigative Center | Detroit | Michigan | 48201 | United States |
| FSGS Investigative Center | Minneapolis | Minnesota | 55414 | United States |
| FSGS Investigative Centre | St Louis | Missouri | 63110 | United States |
| FSGS Investigative Center | Newark | New Jersey | 07103 | United States |
| FSGS Investigative Center | New York | New York | 10032 | United States |
| FSGS Investigative Center | Chapel Hill | North Carolina | 27599-7155 | United States |
| FSGS Investigative Center | Charlotte | North Carolina | 28204 | United States |
| FSGS Investigative Center | Columbus | Ohio | 43210 | United States |
| FSGS Investigative Center | Bethlehem | Pennsylvania | 18017 | United States |
| FSGS Investigative Center | Dallas | Texas | 75231 | United States |
| FSGS Investigative Center | Dallas | Texas | 75246 | United States |
| FSGS Investigative Center | El Paso | Texas | 79935 | United States |
| FSGS Investigative Center | Houston | Texas | 77030 | United States |
| FSGS Investigative Site | Salt Lake City | Utah | 84115 | United States |
| FSGS Investigative Centre | Santiago de los Caballeros | 51000 | Dominican Republic |
| FSGS Investigative Center | Santo Domingo | Dominican Republic |
| 23736966 | Background | 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. |
| 21943027 | Background | 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. |
| Week 1: 7.9 mg Twice Daily |
|
| Week 2: 15.9 mg Twice Daily |
|
| Weeks 3 - 24: 23.7 mg Twice Daily |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Trial ended prematurely before any patients were enrolled into Cohort 2
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Voclosporin Cohort 1 | Cohort 1: Maximum dose of 3 capsules voclosporin (23.7 mg total) twice daily |
| BG001 | Voclosporin Cohort 2 | Trial ended prematurely before any patients were enrolled into Cohort 2 Cohort 2: When Cohort 1 have completed 12 weeks of treatment with voclosporin, the top line efficacy and safety data will be analyzed to determine the dose level for Cohort 2. The selected dose may be higher or lower than 23.7 mg twice daily. The maximum dose possible for Cohort 2 will be 39.5 mg (5 capsules) twice daily. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Subjects With Remission of Proteinuria | Complete remission OR Partial remission | Due to difficulties enrolling appropriate Focal Segmental Glomerulosclerosis (FSGS) patients, Aurinia terminated the clinical trial early. Focal Segmental Glomerulosclerosis (FSGS) is a rare disease with an estimated 40,000 adult patients in the USA. Only five subjects were enrolled into the clinical trial. The primary and secondary endpoints were not assessed due to insufficient data collected | Posted | 24 weeks |
|
| |||||||||||||||||||
| Secondary | Proportion of Subjects With Complete Remission or Partial Remission of Proteinuria | Complete remission or partial remission of proteinuria | Due to difficulties enrolling appropriate Focal Segmental Glomerulosclerosis (FSGS) patients, Aurinia terminated the clinical trial early. Focal Segmental Glomerulosclerosis (FSGS) is a rare disease with an estimated 40,000 adult patients in the USA. Only five subjects were enrolled into the clinical trial. The primary and secondary endpoints were not assessed due to insufficient data collected. | Posted | Weeks 8 and 12 |
|
| |||||||||||||||||||
| Secondary | Proportion of Subjects With Complete Remission of Proteinuria | Complete remission of proteinuria | Due to difficulties enrolling appropriate Focal Segmental Glomerulosclerosis (FSGS) patients, Aurinia terminated the clinical trial early. Focal Segmental Glomerulosclerosis (FSGS) is a rare disease with an estimated 40,000 adult patients in the USA. Only five subjects were enrolled into the clinical trial. The primary and secondary endpoints were not assessed due to insufficient data collected. | Posted | Weeks 8, 12, and 24 |
|
| |||||||||||||||||||
| Secondary | Proportion of Subjects With Reduction of Proteinuria | Reduction of proteinuria | Due to difficulties enrolling appropriate Focal Segmental Glomerulosclerosis (FSGS) patients, Aurinia terminated the clinical trial early. Focal Segmental Glomerulosclerosis (FSGS) is a rare disease with an estimated 40,000 adult patients in the USA. Only five subjects were enrolled into the clinical trial. The primary and secondary endpoints were not assessed due to insufficient data collected. | Posted | Weeks 8, 12, and 24 |
|
| |||||||||||||||||||
| Secondary | Proportion of Subjects With Partial Remission of Proteinuria | Partial remission of proteinuria | Due to difficulties enrolling appropriate Focal Segmental Glomerulosclerosis (FSGS) patients, Aurinia terminated the clinical trial early. Focal Segmental Glomerulosclerosis (FSGS) is a rare disease with an estimated 40,000 adult patients in the USA. Only five subjects were enrolled into the clinical trial. The primary and secondary endpoints were not assessed due to insufficient data collected. | Posted | Weeks 8, 12, and 24 |
|
| |||||||||||||||||||
| Secondary | Time to First Occurrence of Complete or Partial Remission of Proteinuria | Complete OR partial remission of proteinuria | Due to difficulties enrolling appropriate Focal Segmental Glomerulosclerosis (FSGS) patients, Aurinia terminated the clinical trial early. Focal Segmental Glomerulosclerosis (FSGS) is a rare disease with an estimated 40,000 adult patients in the USA. Only five subjects were enrolled into the clinical trial. The primary and secondary endpoints were not assessed due to insufficient data collected. | Posted | Up to 26 weeks |
|
| |||||||||||||||||||
| Secondary | Time to First Occurrence of Complete Remission of Proteinuria | Complete remission of proteinuria | Due to difficulties enrolling appropriate Focal Segmental Glomerulosclerosis (FSGS) patients, Aurinia terminated the clinical trial early. Focal Segmental Glomerulosclerosis (FSGS) is a rare disease with an estimated 40,000 adult patients in the USA. Only five subjects were enrolled into the clinical trial. The primary and secondary endpoints were not assessed due to insufficient data collected. | Posted | Up to 26 weeks |
|
| |||||||||||||||||||
| Secondary | Time to First Occurrence of Partial Remission of Proteinuria | Partial remission of proteinuria | Due to difficulties enrolling appropriate Focal Segmental Glomerulosclerosis (FSGS) patients, Aurinia terminated the clinical trial early. Focal Segmental Glomerulosclerosis (FSGS) is a rare disease with an estimated 40,000 adult patients in the USA. Only five subjects were enrolled into the clinical trial. The primary and secondary endpoints were not assessed due to insufficient data collected. | Posted | Up to 26 weeks |
|
| |||||||||||||||||||
| Secondary | Time to First Occurrence of 50% Reduction in Urine Protein Creatinine Ratio (UPCR) From Baseline | 50% reduction in Urine Protein Creatinine Ratio (UPCR) from baseline | Due to difficulties enrolling appropriate Focal Segmental Glomerulosclerosis (FSGS) patients, Aurinia terminated the clinical trial early. Focal Segmental Glomerulosclerosis (FSGS) is a rare disease with an estimated 40,000 adult patients in the USA. Only five subjects were enrolled into the clinical trial. The primary and secondary endpoints were not assessed due to insufficient data collected. | Posted | Up to 26 weeks |
|
| |||||||||||||||||||
| Secondary | Duration of Reduced Urine Protein Creatinine Ratio (UPCR) | Duration of reduced Urine Protein Creatinine Ratio (UPCR) | Due to difficulties enrolling appropriate Focal Segmental Glomerulosclerosis (FSGS) patients, Aurinia terminated the clinical trial early. Focal Segmental Glomerulosclerosis (FSGS) is a rare disease with an estimated 40,000 adult patients in the USA. Only five subjects were enrolled into the clinical trial. The primary and secondary endpoints were not assessed due to insufficient data collected. | Posted | Up to 26 weeks |
|
| |||||||||||||||||||
| Secondary | Change From Baseline in Urine Protein Creatinine Ratio (UPCR) | Change from baseline in Urine Protein Creatinine Ratio (UPCR) | Due to difficulties enrolling appropriate Focal Segmental Glomerulosclerosis (FSGS) patients, Aurinia terminated the clinical trial early. Focal Segmental Glomerulosclerosis (FSGS) is a rare disease with an estimated 40,000 adult patients in the USA. Only five subjects were enrolled into the clinical trial. The primary and secondary endpoints were not assessed due to insufficient data collected. | Posted | Weeks 2,4,8,12,18,24 |
|
| |||||||||||||||||||
| Secondary | Proportion of Subjects With a Confirmed Decrease From Baseline in Estimated Glomerular Filtration Rate (eGFR) | Utilizing the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula | Due to difficulties enrolling appropriate Focal Segmental Glomerulosclerosis (FSGS) patients, Aurinia terminated the clinical trial early. Focal Segmental Glomerulosclerosis (FSGS) is a rare disease with an estimated 40,000 adult patients in the USA. Only five subjects were enrolled into the clinical trial. The primary and secondary endpoints were not assessed due to insufficient data collected. | Posted | Weeks 2,4,8,12,18,24 |
|
| |||||||||||||||||||
| Secondary | Proportion of Subjects With a Confirmed Increase in Estimated Glomerular Filtration Rate (eGFR) | Increase in Estimated Glomerular Filtration Rate (eGFR) | Due to difficulties enrolling appropriate Focal Segmental Glomerulosclerosis (FSGS) patients, Aurinia terminated the clinical trial early. Focal Segmental Glomerulosclerosis (FSGS) is a rare disease with an estimated 40,000 adult patients in the USA. Only five subjects were enrolled into the clinical trial. The primary and secondary endpoints were not assessed due to insufficient data collected. | Posted | Week 24 to Week 26 |
|
| |||||||||||||||||||
| Secondary | Change in Urine Protein Creatinine Ratio (UPCR) | Change in Urine Protein Creatinine Ratio (UPCR) | Due to difficulties enrolling appropriate Focal Segmental Glomerulosclerosis (FSGS) patients, Aurinia terminated the clinical trial early. Focal Segmental Glomerulosclerosis (FSGS) is a rare disease with an estimated 40,000 adult patients in the USA. Only five subjects were enrolled into the clinical trial. The primary and secondary endpoints were not assessed due to insufficient data collected. | Posted | Week 24 and Week 26 |
|
| |||||||||||||||||||
| Secondary | Change in Estimated Glomerular Filtration Rate (eGFR) | Change in estimated Glomerular Filtration Rate (eGFR) | Due to difficulties enrolling appropriate Focal Segmental Glomerulosclerosis (FSGS) patients, Aurinia terminated the clinical trial early. Focal Segmental Glomerulosclerosis (FSGS) is a rare disease with an estimated 40,000 adult patients in the USA. Only five subjects were enrolled into the clinical trial. The primary and secondary endpoints were not assessed due to insufficient data collected. | Posted | Week 24 and Week 26 |
|
| |||||||||||||||||||
| Secondary | Change From Baseline in Serum Creatinine, Serum Albumin and Estimate Glomerular Filtration Rate (eGFR) | Change from baseline in serum creatinine, serum albumin and estimate Glomerular Filtration Rate (eGFR) | Due to difficulties enrolling appropriate Focal Segmental Glomerulosclerosis (FSGS) patients, Aurinia terminated the clinical trial early. Focal Segmental Glomerulosclerosis (FSGS) is a rare disease with an estimated 40,000 adult patients in the USA. Only five subjects were enrolled into the clinical trial. The primary and secondary endpoints were not assessed due to insufficient data collected. | Posted | Weeks 2,4,8,12,18,24 |
|
| |||||||||||||||||||
| Secondary | Quality of Life Assessments | Mean change in Patient Reported Outcome Measurement Information System (PROMIS) measures | Due to difficulties enrolling appropriate Focal Segmental Glomerulosclerosis (FSGS) patients, Aurinia terminated the clinical trial early. Focal Segmental Glomerulosclerosis (FSGS) is a rare disease with an estimated 40,000 adult patients in the USA. Only five subjects were enrolled into the clinical trial. The primary and secondary endpoints were not assessed due to insufficient data collected. | Posted | Week 24 |
|
| |||||||||||||||||||
| Secondary | Quality of Life Assessments | Change from baseline in Kidney Disease Quality of Life-Short Form (KDQOL-SF) | Due to difficulties enrolling appropriate Focal Segmental Glomerulosclerosis (FSGS) patients, Aurinia terminated the clinical trial early. Focal Segmental Glomerulosclerosis (FSGS) is a rare disease with an estimated 40,000 adult patients in the USA. Only five subjects were enrolled into the clinical trial. The primary and secondary endpoints were not assessed due to insufficient data collected. | Posted | Week 24 |
|
| |||||||||||||||||||
| Secondary | Safety and Tolerability (Treatment-Emergent Adverse Events) | Incidence and number of treatment-emergent adverse events | Due to difficulties enrolling appropriate Focal Segmental Glomerulosclerosis (FSGS) patients, Aurinia terminated the clinical trial early. Focal Segmental Glomerulosclerosis (FSGS) is a rare disease with an estimated 40,000 adult patients in the USA. Only five subjects were enrolled into the clinical trial. The primary and secondary endpoints were not assessed due to insufficient data collected. | Posted | 24 weeks |
|
| |||||||||||||||||||
| Secondary | Renal Biopsy | Descriptive analyses of changes in histopathology will be evaluated in post treatment renal biopsies in a subset of patients | Due to difficulties enrolling appropriate Focal Segmental Glomerulosclerosis (FSGS) patients, Aurinia terminated the clinical trial early. Focal Segmental Glomerulosclerosis (FSGS) is a rare disease with an estimated 40,000 adult patients in the USA. Only five subjects were enrolled into the clinical trial. The primary and secondary endpoints were not assessed due to insufficient data collected. | Posted | 24 weeks |
|
|
Day 1 to Week 26
Trial ended prematurely before any patients were enrolled into Cohort 2
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Voclosporin Cohort 1: Week 1 | Cohort 1: Week 1 7.9 mg twice daily | 0 | 5 | 0 | 5 | 2 | 5 |
| EG001 | Voclosporin Cohort 1: Week 2 | Cohort 1: Week 2 15.9 mg twice daily | 0 | 5 | 0 | 5 | 0 | 5 |
| EG002 | Voclosporin Cohort 1: Weeks 3-24 | Cohort 1: Weeks 3-24 23.7 mg twice daily | 0 | 5 | 1 | 5 | 5 | 5 |
| EG003 | Voclosporin Cohort 2 | Trial ended prematurely before any patients were enrolled into Cohort 2 Cohort 2: When Cohort 1 have completed 12 weeks of treatment with voclosporin, the top line efficacy and safety data will be analyzed to determine the dose level for Cohort 2. The selected dose may be higher or lower than 23.7 mg twice daily. The maximum dose possible for Cohort 2 will be 39.5 mg (5 capsules) twice daily. | 0 | 0 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dehydration | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood creatine phosphokinase increased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Glomerular filtration rate decreased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Cushingoid | Endocrine disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Ocular discomfort | Eye disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
Due to difficulties enrolling appropriate Focal Segmental Glomerulosclerosis (FSGS) patients, Aurinia terminated the clinical trial early. Focal Segmental Glomerulosclerosis (FSGS) is a rare disease with an estimated 40,000 adult patients in the USA. Only five subjects were enrolled into the clinical trial.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Support | Aurinia Pharmaceuticals Inc. | 1 (250) 744-2487 | clinicaltrials@auriniapharma.com |
| May 17, 2021 |
| Prot_SAP_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Protocol v2.0 (Amendment 1) | Nov 23, 2018 | May 17, 2021 | Prot_SAP_001.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Protocol v3.0 (Amendment 2) | May 31, 2019 | May 17, 2021 | Prot_SAP_002.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Protocol v4.0 (Amendment 3) | Dec 20, 2019 | May 17, 2021 | Prot_SAP_003.pdf |
Not provided
| ID | Term |
|---|---|
| D005923 | Glomerulosclerosis, Focal Segmental |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C484071 | voclosporin |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|