| Outcome Measures: |
Primary: Percentage of Participants With ≥ 30% Decrease in Albuminuria (ACR) at 12 Months, The effect of SEG101 on clinical disease activity was measured by at least 30% decrease in Albumin to Creatinine Ratio (ACR) from baseline to month 12. A reduction from baseline indicates improvement in patients., Baseline to 12 months | Secondary: Change From Baseline in Albuminuria (ACR) at 3, 6, 9 and 12 Months, The effect of SEG101 on clinical disease activity was measured by the change in albuminuria (ACR) between baseline and month 3, baseline and month 6, baseline and month 9, baseline and month 12. A reduction from baseline indicates improvement in patients., Baseline to 3, 6, 9, and 12 months|Percentage of Participants With ≥ 30% Decrease in Albuminuria (ACR) at 6 Months, The effect of SEG101 on clinical disease activity was measured by at least 30% decrease in Albumin to Creatinine Ratio (ACR) from baseline to month 6. A reduction from baseline indicates improvement in patients., Baseline to 6 months|Percentage of Participants With Protein/Creatinine Ratio (PCR) Improvement and Stable PCR at 12 Months, The effect of SEG101 on clinical disease activity was measured by counting patients who had Stable PCR: within ± 20% change from baseline to month 12. PCR improvement: ≥ 20% decrease in PCR from baseline indicates improvement in patients., Baseline to 12 months|Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR), The percentage change in eGFR was calculated as the post-baseline eGFR value minus the baseline eGFR divided by the eGFR at baseline. A reduction from baseline indicates improvement in participants., Baseline to 3, 6, 9, and 12 months|Slope of Albumin to Creatinine Ratio (ACR) Decline, The effect of SEG101 on clinical disease activity was measured by the slope of ACR decline between baseline and Month 12. A reduction from baseline indicates improvement in patients., Baseline to 12 months|Slope of Estimated Glomerular Filtration Rate (eGFR) Decline, The effect of SEG101 on clinical disease activity was measured by the slope of eGFR between baseline and Month 12. The calculation of eGFR is based on the chronic kidney disease epidemiology collaboration (CKD-EPI) (for patients ≥ 18) and Creatinine-based "Bedside Schwartz" (for patients \< 18) equations. A reduction in drop rate from baseline indicates improvement in patients., Baseline to 12 months|Percentage of Participants With Progression of Chronic Kidney Disease (CKD) at 12 Months, The effect of SEG101 on clinical disease activity was measured by percentage of participants with CKD progression between baseline and Month 12. A reduction from baseline indicates improvement in participants. CKD progression is defined as an increase in CKD progression category, a 25% or greater drop in eGFR from baseline or at least 50% increase in ACR for patients with severe (A3) albuminuria and a doubling of albumin levels in patients with moderate (A2) albuminuria., Baseline to 12 months|Shift Table for Chronic Kidney Disease (CKD) Progression, The effect of SEG101 on clinical disease activity was measured by percentage of participants with CKD progression between baseline and Month 12. A reduction from baseline indicates improvement in patients., Baseline and month 12|Immunogenicity: Percentage of Participants With Anti-drug Antibodies (ADA) to Crizanlizumab, The effect of SEG101 on clinical disease activity was measured by percentage of participants shifted to different worst post-baseline categories between baseline and Month 12. An increase in percentage shifting from higher category to lower category indicates improvement in patients. Baseline is defined as the last non-missing value prior to the first dose., Baseline to follow-up period (at select time points), assessed up to approximately 1 year and 4 months|Annualized Rate of Visits to Emergency Room (ER) and Hospitalizations, The effect of SEG101 on clinical disease activity was measured by summarizing the annualized rate of visits to ER and hospitalizations between baseline and 1 year 4 months. Annualized rate of hospitalizations and ER visits due to VOC =(Number of ER or hospitalizations reported until End date x 365.25)/(End date-date of first dose of study treatment+1). A reduction from baseline indicates improvement in patients., Baseline to follow-up period (at select time points), assessed up to approximately 1 year and 4 months|Mean Serum Concentration (Ctrough) of Crizanlizumab, The effect of SEG101 on clinical disease activity was measured by checking the concentration of the Drug in serum at different time points. Crizanlizumab pre-dose/trough pharmacokinetic samples were taken at select time points., Pre-dose and 336 hours post-dose on Week 3 Day 1; pre-dose and 672 hours post dose on Week 11 Day 1, Week 23 Day 1 and Week 39 Day 1; and 672 hours post dose on Week 53 Day 1
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| Locations: |
University of Alabama Birmingham, Birmingham, Alabama, 35233, United States|University of Illinois Hospital and Health Sciences System ., Chicago, Illinois, 60612, United States|Our Lady of the Lake Regional Medic ., Baton Rouge, Louisiana, 70809, United States|East Carolina University BrodySchool of Med 3, Greenville, North Carolina, 27858, United States|Univ of Tenn Health Sciences Ctr, Memphis, Tennessee, 38163, United States|University of Texas Health Science Center at Houston, Houston, Texas, 77030, United States|Novartis Investigative Site, Rio de Janeiro, RJ, 20.211-030, Brazil|Novartis Investigative Site, São Paulo, SP, 01232-010, Brazil|Novartis Investigative Site, Porto Alegre, 90035-003, Brazil|Novartis Investigative Site, Creteil, 94010, France|Novartis Investigative Site, Paris 15, 75015, France|Novartis Investigative Site, Athens, 115 27, Greece|Novartis Investigative Site, Larisa, 41221, Greece|Novartis Investigative Site, Dublin 8, DO8, Ireland|Novartis Investigative Site, Tripoli, 1434, Lebanon|Novartis Investigative Site, Amsterdam, 1105 AZ, Netherlands|Novartis Investigative Site, Panama, 0801, Panama|Novartis Investigative Site, Barcelona, Catalunya, 08035, Spain|Novartis Investigative Site, Adana, 01250, Turkey|Novartis Investigative Site, Adana, 01330, Turkey|Novartis Investigative Site, Antakya / Hatay, 31100, Turkey|Novartis Investigative Site, London, SE1 9RT, United Kingdom|Novartis Investigative Site, London, SE5 9RS, United Kingdom|Novartis Investigative Site, London, W12 0HS, United Kingdom
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