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2630 : Steadfast: A Randomized, Multicenter, Open-Label, Phase II Study Comparing the Effect of Crizanlizumab Plus Standard of Care (SoC) Versus Soc Alone on Renal Function in Patients with Chronic Kidney Disease Due to Sickle Cell Nephropathy

Researchers

Presenter

  • Kenneth I. Ataga

Principal Investigators

  • Santosh L. Saraf

  • Vimal K. Derebail

  • Claire C. Sharpe

  • Adlette Inati

  • Jeffrey D. Lebensburger

  • Laurie DeBonnett

  • Yifan Zhang

  • Pablo Bartolucci

Medical Centers

  • UTHSC Center for Sickle Cell Disease, Memphis, TN

  • Comprehensive Sickle Cell Center, Section of Hematology/Oncology, Department of Medicine, University of Illinois at Chicago, Chicago, IL

  • University of North Carolina Kidney Center, Division of Nephrology and Hypertension, Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC

  • Renal Sciences, Department of Inflammation Biology, King’s College London, London, United Kingdom

  • Lebanese American University, School of Medicine, Beirut and Division of Pediatric Hematology and Oncology, Nini Hospital,Tripoli,Lebanon

  • Division of Clinical Rheumatology and Immunology, University of Alabama at Birmingham, Birmingham, AL

  • Novartis Pharmaceutical Corporation, East Hanover, NJ

  • Medecine Interne, Hopital Henri Mondor, Assistance Publique Hopitaux de Paris, Universite Paris Est, Creteil, France

Locations

  • United States

  • United Kingdom

  • Lebanon

  • France

Companies

  • Novartis AG

Study Components

Therapeutic Area

  • Blood/haematological Diseases

Disease

  • Sickle cell nephropathy

  • Chronic kidney disease

  • Acute renal failure

  • Renal disease

  • Thalassemia

Biomarkers

  • Stearoyl-CoA desaturase

  • Albumin/creatinine

Drug/Treatment

  • SelG1

Outcome

  • N/A

Study Design

  • Randomized

  • Open Label

  • Multicenteric

Phase

  • II

Study Id's

  • NCT04053764

Sponsors

  • N/A

Result

  • N/A

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