Outcome Measures: |
Primary: Composite of Dialysis Initiation, Kidney Transplantation, and Serum Creatinine Doubling. Number of Participants Meeting the Criteria Are Reported., Beyond Week 48, a 12-week visit cycle continued until the end of the study or until individual patients reached an endpoint|Number of Participants With Treatment-emergent Adverse Events and Treatment-emergent Serious Adverse Events, Approximately 42 months | Secondary: Number of Participants Who Developed a Component of a Quadruple Composite Endpoint (Initiation of Dialysis, Kidney Transplant, Doubling of sCr, or Death), Approximately 42 months|Vitamin A Levels, Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, Early Term/Discontinuation (Mean: 428.615 Days), Final Visit (Mean: 947.354 Days)|Vitamin B12 Levels, Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, Early Term/Discontinuation (Mean: 428.114 Days), Final Visit (Mean: 947.239 Days)|25-Hydroxyvitamin D Levels, Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, Early Term/Discontinuation (Mean: 427.270 Days), Final Visit (Mean: 946.762 Days)|Vitamin E Levels, Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, Early Term/Discontinuation (Mean: 428.056 Days), Final Visit (Mean: 946.525 Days)|Vitamin K Levels, Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 441.826 Days), Final Visit (Mean: 946.463 Days)|Serum Folate Levels, Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 423.024 Days), Final Visit (Mean: 946.074 Days)
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Locations: |
Phoenix, Arizona, United States|Little Rock, Arkansas, United States|Alhambra, California, United States|Covina, California, United States|Glendale, California, United States|Los Angeles, California, United States|Stamford, Connecticut, United States|Washington, District of Columbia, United States|Hudson, Florida, United States|Miami, Florida, United States|Ocala, Florida, United States|Orlando, Florida, United States|Pembroke Pines, Florida, United States|Spring Hill, Florida, United States|Tampa, Florida, United States|Winter Park, Florida, United States|Kansas City, Kansas, United States|New Orleans, Louisiana, United States|Shreveport, Louisiana, United States|Ypsilanti, Michigan, United States|Kansas City, Missouri, United States|Saint Louis, Missouri, United States|Camden, New Jersey, United States|Eatontown, New Jersey, United States|Port Washington, New York, United States|Springfield Gardens, New York, United States|Asheville, North Carolina, United States|Cincinnati, Ohio, United States|Dayton, Ohio, United States|Toledo, Ohio, United States|Portland, Oregon, United States|Philadelphia, Pennsylvania, United States|Pittsburgh, Pennsylvania, United States|Rock Hill, South Carolina, United States|Nashville, Tennessee, United States|Arlington, Texas, United States|Dallas, Texas, United States|Houston, Texas, United States|San Antonio, Texas, United States|Appleton, Wisconsin, United States|Oshkosh, Wisconsin, United States|Buenos Aires, Argentina|Cordoba, Argentina|San Luis, Argentina|San Pedro, Argentina|Tucuman, Argentina|Barao Geraldo-Campinas, Brazil|Belo Horizonte Minas Gerais, Brazil|Juiz de Fora, Brazil|Porto Alegre, Brazil|Rio de Janeiro, Brazil|São Paulo, Brazil|Taubaté, Brazil|Winnipeg, Manitoba, Canada|Brampton, Ontario, Canada|Kitzhener, Ontario, Canada|Oakville, Ontario, Canada|Scarborough, Ontario, Canada|Toronto, Ontario, Canada|Montreal, Quebec, Canada|Ceske Budejovice, Czechia|Jihlava, Czechia|Ostrava - Poruba, Czechia|Praha, Czechia|Tabor, Czechia|Grenoble, France|Lyon, France|Nantes, France|Saint-Lo, France|Bologna, Italy|Brescia, Italy|Como, Italy|Pavia, Italy|Aguascalientes, Mexico|Mexico City, Mexico|Tijuana, Mexico|Gdansk, Poland|Szczecin, Poland|Torun, Poland|Warszawa, Poland|Caguas, Puerto Rico|Bamaul, Russian Federation|Ekaterinburg, Russian Federation|Kazan, Russian Federation|Krasnodar, Russian Federation|Moscow, Russian Federation|Nizhniy Novgorod, Russian Federation|Novosibirsk, Russian Federation|Pyatigorsk, Russian Federation|Ryazan, Russian Federation|Saratov, Russian Federation|Smolensk, Russian Federation|Sochi, Russian Federation|St. Petersburg, Russian Federation|Stavropol, Russian Federation|Chernovtsy, Ukraine|Dnipropetrovsk, Ukraine|Donetsk, Ukraine|Ivano-Frankivsk, Ukraine|Kharkov, Ukraine|Kiev, Ukraine|Odessa, Ukraine|Uzhgorod, Ukraine|Vinnitsa, Ukraine|Zhytomir, Ukraine
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