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, Early Term/Discontinuation (Mean: 430.293 Days), Final Visit (Mean: 908.486 Days)|Vitamin B12 Levels, Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 425.112 Days), Final Visit (Mean: 910.988 Days)|25-Hydroxyvitamin D Levels, Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 429.695 Days), Final Visit (Mean: 908.601 Days)|Vitamin E Levels, Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 427.067 Days), Final Visit (Mean: 908.715 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: 432.942 Days), Final Visit (Mean: 910.448 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: 420.569 Days), Final Visit (Mean: 909.848 Days)
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Locations: |
Tuscaloosa, Alabama, United States|Hot Springs, Arkansas, United States|Bakersfield, California, United States|Glendale, California, United States|Los Angeles, California, United States|Palo Alto, California, United States|Riverside, California, United States|Denver, Colorado, United States|Boynton Beach, Florida, United States|West Palm Beach, Florida, United States|Augusta, Georgia, United States|Macon, Georgia, United States|Honolulu, Hawaii, United States|Evergreen Park, Illinois, United States|Shawnee Mission, Kansas, United States|Kenner, Louisiana, United States|Shreveport, Louisiana, United States|Pontiac, Michigan, United States|Brooklyn Center, Minnesota, United States|Flushing, New York, United States|Great Neck, New York, United States|New York, New York, United States|Williamsville, New York, United States|Elizabeth City, North Carolina, United States|Cincinnati, Ohio, United States|Bend, Oregon, United States|Allentown, Pennsylvania, United States|Doylestown, Pennsylvania, United States|Lancaster, Pennsylvania, United States|Providence, Rhode Island, United States|Charleston, South Carolina, United States|Columbia, South Carolina, United States|Orangeburg, South Carolina, United States|Sumter, South Carolina, United States|Knoxville, Tennessee, United States|Nashville, Tennessee, United States|Dallas, Texas, United States|Houston, Texas, United States|Arlington, Virginia, United States|Fairfax, Virginia, United States|Norfolk, Virginia, United States|Richmond, Virginia, United States|Suffolk, Virginia, United States|Vancouver, Washington, United States|Morgantown, West Virginia, United States|Milwaukee, Wisconsin, United States|Buenos Aires, Argentina|Cordoba, Argentina|Tucumán, Argentina|Belo Horizonte, Brazil|Botucatu, Brazil|Campinas, Brazil|Curitiba, Brazil|Ibirapuera, Brazil|Porto Alegre, Brazil|Rio de Janeiro, Brazil|Sorocaba, Brazil|São Paulo, Brazil|Calgary, Alberta, Canada|Vancouver, British Columbia, Canada|Greenfield Park, Quebec, Canada|Montreal, Quebec, Canada|Hradec Kralove, Czechia|Liberec, Czechia|Praha, Czechia|Usti nad Labem, Czechia|Hamburg, Germany|Kiel, Germany|Mainz, Germany|Aguascalientes, Mexico|Cuernavaca, Mexico|Durango, Mexico|Mexico City, Mexico|Mexico, Mexico|Bialystok, Poland|Czestochowa, Poland|Lublin, Poland|Warszawa, Poland|San Juan, Puerto Rico|Arkhangelsk, Russian Federation|Chelyabinsk, Russian Federation|Ekaterinburg, Russian Federation|Kemerovo, Russian Federation|Moscow, Russian Federation|Novosibirsk, Russian Federation|Orenburg, Russian Federation|Petrozavodsk, Russian Federation|Saratov, Russian Federation|St. Petersburg, Russian Federation|Tomsk, Russian Federation|Yaroslayl, Russian Federation|A Coruña, Spain|Asturias, Spain|Barcelona, Spain|Guadalajara, Spain|Madrid, Spain|Ivano-Frankivsk, Ukraine|Kharkov, Ukraine|Kiev, Ukraine|Lugansk, Ukraine|Lviv, Ukraine|Nikolaev, Ukraine|Poltava, Ukraine|Ternopol, Ukraine|Vinnitsa, Ukraine|Zaporizhzhya, Ukraine
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