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  "documentTitle": "Calliditas Therapeutics | IPO Presentation Deck | 38 slides",
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  "presentationDate": "2020-06-01 00:00:00",
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  "notes": "The slide outlines clinical trial parameters for a drug candidate (Nefecon) targeting IgA Nephropathy.",
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      "text": "Inclusion criteria: Biopsy-confirmed primary IgA Nephropathy (IgAN), >=18 years, Total urine protein >= 1g/day, eGFR >= 35 and <= 90 mL/min, Stable RAS treatment for 3 months.",
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      "text": "Main differences from Phase 2b: Aligning to KDIGO guidelines - slightly more severe patients in phase 3. Total urine protein from >=0.75 g/day to 1g/day. eGFR from > 45 to >=35 and <=90 mL/min/1.73m2.",
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      "text": "Part B: N=360 (including Part A patients). Primary endpoint: difference in kidney function between treated and placebo patients as measured by eGFR over a 2-year period. Readout expected in 2022.",
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      "text": "Exclusion criteria: Secondary forms of IgAN, TB, Kidney transplanted patients, Treatment with high dose corticosteroids or immunosuppressants in the past 12 months.",
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      "text": "Part A: N=200, two arms; 16mg Nefecon and placebo; global trial in 19 countries and approximately 150 sites. Primary endpoint: decrease in UPCR at 9 months. Fully recruited as of Dec. 2019 with topline results expected in 4Q 2020.",
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