| Outcome Measures: |
Primary: Yearly Reduction Rate of Estimated Glomerular Filtration Rate (eGFR) Calculated by Modification of Diet in Renal Disease With 4 Variables (MDRD-4), The yearly reduction in eGFR was calculated using the MDRD-4 formula. This formula is based on age, sex, and serum creatinine and eGFR values are calculated as follows: GFR in milliliter per minute (mL/min) per 1.73 meter square (m\^2) = 175 x Serum Cr\^-1.154 x age\^-0.203 x 0.742 (if female). The yearly reduction rate (mL/min/1.73m\^2 / Year) is defined as -365.25 multiplied by Beta, where Beta is the slope parameter derived for each participants separately by simple linear regression of the change from baseline in participant's eGFR measurements (from Baseline to Visit 24) on the actual day of measurement., 24 months | Secondary: Yearly Reduction Rate of Estimated Glomerular Filtration Rate (eGFR) Calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), The eGFR value calculated using the CKD-EPI equation. The formula used is based on age, sex, ethnicity, and serum creatinine and eGFR values are calculated as follows: GFR in mL/min per 1.73 m\^2 = 141 x min (SerumCr/k; 1)\^a x max(SerumCr/k; 1)\^(-1.209) x 0.993\^age x F x B, where k=0.7 for female (else=0.9); a=-0.329 for female (else=-0.411), F=1.018 for female (else=1), B=1.159 for black (else=1), min/max=minimum/maximum of listed values. The Yearly Reduction Rate (mL/min/1.73m\^2 / Year) is defined as -365.25 x Beta, where Beta is the slope parameter derived for each participant separately by simple linear regression of the change from baseline in participant's eGFR measurements (from Baseline to Visit 24) on the actual day of measurement., 24 months|Change From Baseline in Calculated Creatinine Clearance (Cockcroft-Gault Equation) at Month 24, Creatinine clearance was calculated according to the Cockcroft and Gault Formula. It measures rate creatinine (substance formed from metabolism of creatine) is cleared from blood by kidneys. Normal adult creatinine clearance is greater than or equal to (\>=) 90 mL/min. Change from baseline=CC at Week X minus CC at baseline where higher scores represented improved renal function., Baseline, Month 24|Change From Baseline in Serum Creatinine Concentration at Month 24, Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. Normal adult blood levels of creatinine=45 to 90 micromoles per liter (mcmol/L) for females, 60 to 110 mcmol/L for males, however normal values are age-dependent., Baseline, Month 24|Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Month 24, UACR is defined as the ratio: milligram of albumin per gram of creatinine. The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples., Baseline, Month 24|Change From Baseline in Serum Cystatin C Concentration at Month 24, Cystatin C is a protein which is mainly used as a biomarker of kidney function. If kidney function and GFR decline, the blood levels of cystatin C rise., Baseline, Month 24|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs), An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; and congenital anomaly. Percentage of participants with AEs included participants affected with both SAEs and non-SAEs., 24 months
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| Locations: |
Uniklinik RWTH Aachen; Med. Klinik II; Klinik für Nephrologie und klinische Immunologie, Aachen, 52057, Germany|Dialysepraxis Dr. Stallforth, Dr. Kirschner, Dr. Al-Sarraf und Dr. Pawlik, Augsburg, 86157, Germany|KfH Kuratorium für Dialyse und Nierentransplantation e.V. im Kurhaus, Bad König, 64732, Germany|Charité - Klinikum Mitte; Medizinische Klinik Für Nephrologie, Berlin, 10117, Germany|Charité - Campus Benjamin Franklin; Zentrum fuer Innere Medizin, Med. Klinik I, Berlin, 12203, Germany|Gemeinschaftspraxis Dres. Erika Eger, Frank Seibt, Oliver Eike u.w. - Dialysezentrum Treptower Park, Berlin, 12435, Germany|Dialyse-Institut Bovenden, Bovenden, 37120, Germany|Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik III, Dresden, 01307, Germany|DaVita Clinical Research Deutschland GmbH, Düsseldorf, 40210, Germany|Universitätsklinikum Essen Zentrum f.Innere Medizin Abt.Nephrologie, Essen, 45122, Germany|Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik III, Frankfurt, 60596, Germany|Uniklinikum Heidelberg, Heidelberg, 69120, Germany|Dialysepraxis Prof.Dr.med. Michael Rambausek Dres. Stephan Matthias und Gabriele Kunowski - Dialysz., Heilbronn, 74076, Germany|Nephrologisches Zentrum Hilden am St. Josefs-Krankenhaus, Hilden, 40724, Germany|Universitaetsklinikum des Saarlandes; Klinik f. Innere Medizin IV, Homburg/Saar, 66424, Germany|Dres. Jan Nawka und Frank Pistrosch, Hoyerswerda, 02977, Germany|Westpfalz-Klinikum Gmbh; Nephrologie/Transplantationsmedizin, Kaiserslautern, 67655, Germany|PHV Patienten-Heimversorgung Dialyse-Station, Kiel, 24106, Germany|Kliniken der Stadt Köln gGmbH Krankenhaus Merheim, Köln, 51109, Germany|Universitätsklinikum Schleswig-Holstein / Campus Lübeck, Med. Klinik I, Transplantationszentrum, Lübeck, 23562, Germany|Gemienschaftspraxis Dres. Leistikow, Rachti & Sandner, Mannheim, 68309, Germany|Dres. Michael Koch Hannelore Klimke Wolfgang Kulas u.w., Mettmann, 40822, Germany|Klinikum Innenstadt Medizinische Klinik; Abt.Endokrinologie und Diabetologie, Muenchen, 80336, Germany|Nierenzentrum Bogenhausen/Perlach; Praxis für Nierenheilkunde, München-Bogenhausen, 81925, Germany|Klinikum d.Universität München Campus Großhadern, München, 81377, Germany|Universitätsklinikum Münster Innere Medizin D, Münster, 48149, Germany|Dres. Georg Fuchs und Nexhat Miftari, Neckarsulm, 74172, Germany|Nephrologische Praxis Neunkirchen - Dr.med. Klemens Dorr und Artem Goldmann, Neunkirchen/Saar, 66538, Germany|Dialysezentrum Saarlouis, Saarlouis, 66740, Germany|Gemeinschaftspraxis Rosemarie Krämer und Lars Rothermund, Ulm, 89077, Germany|Nephrologisches Zentrum, Velbert, 42549, Germany|Nephrologisches Zentrum Dialyse-Institut, Villingen-Schwenningen, 78052, Germany|KfH Kuratiorium für Dialyse und Nierentransplantation e.V., Wiesbaden, 65191, Germany
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