Clinical Trial Search

Primary: Double-blind Period: Percentage of Participants With Primary Efficacy Renal Response (PERR) at Week 104 — 32.3; 43.0 Percentage of participants — p=0.0311

Primary: Number of Participants With Complete Response — 22; 21 participants — p=0.85

Primary: Percentage of Participants With At Least One Grade 3 or Higher Infectious Adverse Event By Week 24, Week 48 and Week 96 — 9.1; 4.8; 22.7; 9.5 percentage of participants…

Primary: Percentage of Participants Who Achieved a Complete Renal Response (CRR), a Partial Renal Response (PRR), or no Renal Response (NRR) at Week 52 — 26.4; 30.6; 30.6; 15.3…

Primary: Percentage of Patients With Complete Renal Response (CRR) at Week 52 — 38.32; 44.95; 44.56; 48.33 Percentage of Participants — p=0.7271

Primary: Complete and Partial Response Rate — 55 Percentage of participants

Primary: Percentage of Participants Who Achieve Protocol Defined Complete Renal Response (CRR) at Week 52 — 22; 14 Participants — p=0.1145

Primary: Effect of Dapagliflozin Compared to Placebo on Renal Function After One Year — 128; 114; 115.7; 100.3 mL/min/1.73 m²

Primary: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) — 33; 18; 6; 3 Participants

Primary: Number of Participants With Adverse Events (AEs) — 14; 15; 15 participants

Primary: Induction Phase: Number of Patients Showing Treatment Response — 98; 104; 87; 81 participants — p=0.478

Primary: Number of Participants Categorized by Demographic Characteristics — 143; 50; 88; 3 Participants

Primary: Percentage of Patients With Complete Renal Response (CRR) and Without Any Renal Flares — 51.83; 48.15; 59.49; 57.51 Percentage of participants — p=0.7957

Primary: Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (UPCR) — 0.326; 0.285; 0.305; 0.296 milligram/milligram (mg/mg) — p=0.9052

Primary: Number of Patients With Complete Remission — 8; 8; 34; 31 Participants

Primary: Change From Baseline in Decisional Conflict Scale Scores — 21.80; 12.69 units on a scale — p=0.005

Primary: Number of Subjects Achieving Complete Renal Remission at 24 Weeks — 29; 24; 17; 60 Participants — p=0.045

Primary: Relapse-free Complete Clinical Response — 54 Months

Primary: Number of Participants With Adjudicated Renal Response at Week 52 — 73; 40; 106; 138 Participants — p=<0.001

Primary: Percent Change in Urine Protein From Baseline (Day 1) to Week 16 — -2.8; -51.2 percent change

Primary: MCP-Mod Estimates of the Ratio to Baseline of Urine Protein to Creatinine Ratio (UPCR) (g/Mol) - Parts 1 and 2 at Day 90 — 0.85; 0.80; 0.76; 0.69 Ratio to baseline…

Primary: Number of Treatment Emergent Adverse Events — 0; 17; 2; 4 Participants

Primary: Change in Proteinuria at 12 Months — 3; 3; 1; 2 participants

Primary: Change From Baseline in Proteinuria Levels at Week 28 — 0.7552 Ratio

Primary: Percentage of Complete Remission — 4; 3 Participants

Primary: Reduction of the Disease Activity as Measured by SLEDAI and BILAG Scores. — 10.2; 28.4 score on a scale

Primary: Safety and Tolerability as Assessed by Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — 23; 24; 2; 2 Participants

Primary: Number of Participants With Treatment-emergent Adverse Events Following Administration With DS-7011a in Participants With Systemic Lupus Erythematosus — 11; 4 Participants

Primary: Change in 24 Hour Creatinine Clearance — 41.0 mL/min/SA — p=0.072

Primary: Remission Status — 39; 13 Participants — p=0.001