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Clinical Trial Details

Trial ID: L0998
Source ID: NCT01130831
Associated Drug: Lanthanum Carbonate
Title: Effect of Lanthanum Carbonate in Patients Previously Treated With Calcium-based Phosphate Binder Therapy
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01130831/results
Conditions: End Stage Renal Disease
Interventions: DRUG: Lanthanum carbonate
Outcome Measures: Primary: Percent of Subjects That Achieved Controlled Serum Phosphorous Levels on Calcium-based Phosphate Binder Therapy, Phosphorous levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous of 3.5-5.5 mg/dL., Baseline|Percent of Subjects That Achieved Controlled Serum Phosphorous Levels on Lanthanum Carbonate, Phosphorous levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous of 3.5-5.5 mg/dL., 12 months | Secondary: Percent of Subjects That Achieved Controlled Serum Calcium Levels on Calcium-based Phosphate Binder Therapy, Calcium levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium of 8.4-9.5 mg/dL., Baseline|Percent of Subjects That Achieved Controlled Serum Calcium Levels on Lanthanum Carbonate Therapy, Calcium levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium of 8.4-9.5 mg/dL., 12 months|Percent of Subjects That Achieved Controlled Serum Calcium-Phosphorous Product Levels on Calcium-based Phosphate Binder Therapy, Calcium-phosphorous product levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium-phosphorous product of \<55 mg\^2/dL\^2., Baseline|Percent of Subjects That Achieved Controlled Serum Calcium-Phosphorous Product Levels on Lanthanum Carbonate Therapy, Calcium-phosphorous product levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium-phosphorous product of \<55 mg\^2/dL\^2., 12 months|Percent of Subjects That Maintained Control of Serum Phosphorous Levels on Lanthanum Carbonate, Phosphorous levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous of 3.5-5.5 mg/dL., 12 months|Percent of Subjects That Maintained Control of Serum Calcium Levels on Lanthanum Carbonate, Calcium levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium of 8.4-9.5 mg/dL., 12 months|Percent of Subjects That Maintained Control of Serum Calcium-Phosphorous Product Levels on Lanthanum Carbonate Therapy, Calcium-phosphorous product levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium-phosphorous product of \<55 mg\^2/dL\^2., 12 months|Percent of Subjects That Maintained Control of Intact Parathyroid Hormone (iPTH) Levels on Lanthanum Carbonate Therapy, iPTH levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for iPTH of 150-300 pg/mL, 12 months|Percent Change From Baseline in Phosphorous Levels at 12 Months, Baseline and 12 months|Percent Change From Baseline in Calcium Levels at 12 Months, Baseline and 12 months|Percent Change From Baseline in Calcium-Phosphorous Product Levels at 12 Months, Baseline and 12 months|Percent Change From Baseline in iPTH Levels at 12 Months, Baseline and 12 months|Percent Change From Baseline in 25-Hydroxy Vitamin D Levels at 12 Months, Baseline and 12 months|Percent Change From Baseline in 1,25-Hydroxy Vitamin D Levels at 12 Months, Baseline and 12 months|Percent of Subjects With Hypocalcemic Events on Calcium-based Phosphate Binder Therapy, Hypocalcemia is defined as serum calcium levels below 8.02 mg/dL, Baseline|Percent of Subjects With Hypocalcemic Events on Lanthanum Carbonate, Hypocalcemia is defined as serum calcium levels below 8.02 mg/dL, 12 months|Percent of Subjects With Hypercalcemic Events on Calcium-based Phosphate Binder Therapy, Hypercalcemia is defined as total serum calcium level above 11.22 mg/dL., Baseline|Percent of Subjects With Hypercalcemic Events on Lanthanum Carbonate, Hypercalcemia defined as total serum calcium above 11.22 mg/dL, 12 months|Change From Baseline in Vitamin D Dose at 12 Months, Baseline and 12 months|Change From Baseline in Mean Total Daily Dose of Calcium at 12 Months, Baseline and 12 months|Number of Tablets Per Day, 12 months
Sponsor/Collaborators: Sponsor: Shire
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 66
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2010-04-26
Completion Date: 2012-06-12
Results First Posted: 2013-07-04
Last Update Posted: 2021-06-28
Locations: Dialysezentrum Facharzt für Innere Medizin und Nephrologie, Homberg, Hesse, 34576, Germany|Dialyse Alsfeld, Alsfeld, 36304, Germany|Nephrologische Praxis Altötting-Burghausen, Altötting, 84503, Germany|Dialyse am Treptower Park, Berlin, 12435, Germany|Dialyse Berlin, Berlin, 12627, Germany|Dialysezentrum Cochem, Cochem, 56812, Germany|Dialysezentrum Coesfeld, Coesfeld, 48653, Germany|MVZ Caspar-David-Friedrich-Str., Dresden, 01217, Germany|Dialysezentrum Karlstraße, Düsseldorf, 40210, Germany|Dialysezentrum Süd, Düsseldorf, 40589, Germany|KfH-Nierenzentrum Eberswalde, Eberswalde, 16225, Germany|Arzt für Dialyse, Facharzt für Innere Medizin und Nephrologie, Essen, 45127, Germany|Dialysezentrum Lauerwald, Gera, 07548, Germany|Dialysezentrum Grevenbroich, Grevenbroich, 41516, Germany|Dialyse im Heidering, Hannover, 30625, Germany|Dialysepraxen Herne und Wanne-Eickel, Herne, 44623, Germany|Dialyse Herzberg, Herzberg, 04916, Germany|Patienten-Heimversorgung, Hildesheim, 31134, Germany|Universitätsklinik des Saarlandes, Homburg / Saar, 66421, Germany|Nierenzentrum Mannheim, Mannheim, 68309, Germany|Dialysepraxis, Meiningen, 98617, Germany|Dialyse Mettmann, Mettmann, 40822, Germany|Nierenzentrum Bogenhausen, München, 81925, Germany|Nephrologie Nettetal, Nettetal, 41334, Germany|Dialysenzentrum Peine, Peine, 31224, Germany|Facharzt für Innere Medizin und Nephrologie, Potsdam, 14482, Germany|Facharzt für Innere Medizin und Nephrologie, Quedlinburg, 6484, Germany|Nephrologische Praxis Schwetzingen, Schwetzingen, 68723, Germany|PHV-Dialysezentrum Siegen, Siegen, 57076, Germany|Nephrologisches Zentrum, Villingen Schwenningen, Germany|Dialysezentrum Worms, Worms, 67547, Germany
URL: https://clinicaltrials.gov/show/NCT01130831