| Outcome Measures: |
Primary: Percentage of Participants Achieving Age-Specific Kidney Disease Outcomes Quality Initiative (KDOQI) Targets for Serum Phosphate Level Following 8 Weeks of Lanthanum Carbonate Administration (Part 2 + Part 3), KDOQI serum phosphorus targets were defined for: Adolescents aged greater than or equal to (\>=) 12 to less than (\<) 18 years to be less than or equal to (\<=) 5.5 milligrams per deciliter (mg/dL) (1.78 millimoles per liter \[mmol/L\]); Children aged \>=10 years to \<12 years to be \<= 6.0 mg/dL (1.94 mmol/L). Percentage of participants achieving age-specific KDOQI targets for serum phosphate level was reported only for the participants who had received lanthanum carbonate during part 2 or part 3. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study., After 8 weeks of lanthanum carbonate administration in Part 2 and/or in Part 3 | Secondary: Percentage of Participants Achieving Age-Specific Kidney Disease Outcomes Quality Initiative (KDOQI) Targets for Serum Phosphate Level During Part 2, KDOQI serum phosphorus targets was defined for: Adolescents aged \>= 12 \< 18 years to be \<= 5.5 mg/dL (1.78 \[mmol/L\]); Children aged \>=10 years to \<12 years to be \<= 6.0 mg/dL (1.94 mmol/L). Percentage of participants achieving age-specific KDOQI targets for serum phosphate level were reported only for the participants who had received calcium carbonate followed by 8 weeks of treatment with lanthanum carbonate in Part 2. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study., Up to 19 weeks|Change From Baseline in Serum Phosphorus Levels Following Treatment With Lanthanum Carbonate After 8 Weeks, Changes from baseline in serum phosphorus levels in hyperphosphatemic children and adolescents with chronic kidney disease (CKD) who are on dialysis, following treatment with lanthanum carbonate for 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study., Baseline, Week 8 of lanthanum carbonate administration in Part 2 and/or in Part 3|Change From Baseline in Calcium Levels Following Treatment With Lanthanum Carbonate After Week 8, Changes from baseline in calcium levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with lanthanum carbonate for 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study., Baseline, Week 8 of lanthanum carbonate administration in Part 2 and/or in Part 3|Change From Baseline in Calcium-Phosphorus Product Levels Following Treatment With Lanthanum Carbonate After Week 8, Changes from baseline in calcium-phosphorus product levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with lanthanum carbonate for 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. The unit of measure for this outcome measure was millimole square per square liter (mmol\^2/L\^2). Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study., Baseline, Week 8 of lanthanum carbonate administration in Part 2 and/or in Part 3|Change From Baseline in Serum Phosphorus Levels Following Treatment With Calcium Carbonate After 8 Weeks and Lanthanum Carbonate After 8 Weeks During Part 2, Changes from baseline in serum phosphorus levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with calcium carbonate after 8 weeks and lanthanum carbonate after 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study., Baseline, Week 8|Change From Baseline in Calcium Levels Following Treatment With Calcium Carbonate After 8 Weeks and Lanthanum Carbonate After 8 Weeks During Part 2, Changes from baseline in calcium levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with calcium carbonate after 8 weeks and lanthanum carbonate after 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study., Baseline, Week 8|Change From Baseline in Calcium-Phosphorus Product Levels Following Treatment With Calcium Carbonate After 8 Weeks and Lanthanum Carbonate After 8 Weeks During Part 2, Changes from baseline in calcium-phosphorus product levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with calcium carbonate after 8 weeks and lanthanum carbonate after 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. The unit of measure for this outcome was millimole square per square liter. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study., Baseline, Week 8|Change From Baseline in Serum Phosphorus Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3, Change from baseline in serum phosphorus levels at the last visit of each 8-week treatment period during Part 2 and monthly during the 6-month extension phase (Part 3) were reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study., Baseline, Week 8, 12, 16, 20, 24, 28 and Week 32|Change From Baseline in Calcium Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3, Change from baseline in calcium levels at the last visit of each 8-week treatment period during Part 2 and monthly during the 6- month extension phase (Part 3) were reported.Baseline was defined as the last assessment prior to the first dose of investigational product. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study., Baseline, Week 8, 12, 16, 20, 24, 28 and Week 32|Change From Baseline in Calcium-Phosphorus Product Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3, Change from baseline in calcium-phosphorus product levels at the last visit of each 8-week treatment period during Part 2 and monthly during the 6-month extension phase (Part 3) were reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. The unit of measure of this outcome was millimole square per square liter. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study., Baseline, Week 8, 12, 16, 20, 24, 28 and Week 32|Change From Baseline in Biochemical Bone Markers, Change from baseline in bone turnover markers including bone alkaline phosphatase (ALP), osteocalcin, and sclerostin was reported for combined Part 2 and 3. End of the study (EOS) was defined as the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study., Baseline, Week 8, Week 16 and EOS (up to 42 weeks)|Change From Baseline in Biochemical Bone Markers for Tartrate-Resistant Acid Phosphatase (TRAP), Change from baseline in bone turnover markers for, tartrate-resistant acid phosphatase (TRAP) was reported for combined Part 2 and 3. End of the study was defined as the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study., Baseline, Week 8, Week 16 and EOS (up to 42 weeks)|Change From Baseline in Biochemical Bone Markers for Fibroblast Growth Factor 23 (FGF-23), Change from baseline in bone turnover markers including fibroblast growth factor 23 (FGF-23) was reported for combined Part 2 and 3. End of the study was defined as the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study., Baseline, Week 8, Week 16 and EOS (up to 42 weeks)|Change From Baseline in Biochemical Bone Markers for Parathyroid Hormone (PTH), Change from baseline in bone turnover markers for parathyroid hormone was reported for combined Part 2 and 3. End of the study is the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study., Baseline, Week 8, Week 16 and EOS (up to 42 weeks)|Change From Baseline in Biochemical Bone Markers for Fetuin-A, Change from baseline in bone turnover markers for fetuin-A was reported for combined Part 2 and 3. End of the study is the completion if the participants has benefited from and desires to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study., Baseline, Week 8, Week 16 and EOS (up to 42 weeks)|Change From Baseline in Height, Change from baseline in height for combined Part 2 and Part 3 for each drug at Week 8, 16 and end of study was reported. End of the study was defined as the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study., Baseline, Week 8, Week 16, and EOS (up to 42 weeks)|Change From Baseline in Weight, Change from baseline in weight for combined Part 2 and Part 3 for each drug at Week 8, 16 and end of study was reported. End of the study was defined as the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study., Baseline, Week 8, Week 16, and EOS (up to 42 weeks)
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| Locations: |
Centro Infantil Del Rinon S.R.L, San Miguel de Tucuman, Tucuman, 4000, Argentina|Hospital Luis Calvo Mackenna, Santiago, 7500539, Chile|Hospital Dr. Sotero del Rio, Santiago, 8207257, Chile|Fakultni nemocnice Ostrava, Ostrava, 70852, Czechia|University Hospital Motol, Prague 5, 15006, Czechia|Kinder-und Jugendklinik Erlangen, Erlangen, 91054, Germany|Medizinische Hochschule Hannover, Hannover, 30625, Germany|Semmelweis Egyetem Altalanos Orvostudomanyi Kar, Budapest, Bokay Janos, 1083, Hungary|Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum, Debrecen, 4032, Hungary|Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar, Szeged, 6720, Hungary|Uniwersytecki Dzieciecy Szpital Kliniczny, Bialystok, 15-274, Poland|Uniwersytecki Szpital Dzieciecy w Krakowie, Klinika Nefrologii Dzieciecej ze Stacja Dializ, Krakow, 30663, Poland|NZOZ tri-Medica, Lodz, 93-338, Poland|Uniwersytecki Szpital Kliniczny, Wroclaw, 50556, Poland|Spitalul Clinic de Urgenta pentru Copii Sf. Maria, Iasi, Romania|Spitalul Clinic de Urgenta pentru Copii - Louis Turcanu, Timisoara, 300350, Romania|Children City Clinical Hospital of Saint Vladimir, Moscow, 107014, Russian Federation|Saint-Petersburg State Budgetary Healthcare Institution "Children City Hospital #1", Saint-Petersburg, 198205, Russian Federation|State Budgetary Healthcare Instit. of Sverdiov Region "Regional Children Clinical Hosp #1", Yekaterinburg, 620143, Russian Federation|Cukurova University Faculty of Medicine Paediatric Nephrology, Adana, 01330, Turkey|Izmir Tepecik Training and Research Hospital, Izmir, 4500, Turkey|Manisa Celal Bayar University Hafsa Sultan Hospital, Manisa, 45030, Turkey
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