Back to resultsA Study to Assess the Pharmacokinetics of Lanthanum Carbonate, Investigate and Compare the Efficacy, Safety and Tolerability of Lanthanum Carbonate With Calcium Carbonate in Hyperphosphataemic Children and Adolescents With Chronic Kidney Disease on Dialysis
Primary Purpose
Chronic Kidney Disease, Hyperphosphatemia
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Lanthanum Carbonate
Calcium Carbonate
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease
Eligibility Criteria
Inclusion Criteria:
- Aged 10 years to less than (<) 18 years of age at the time of consent.
- Participant or parent/legally authorized representative (LAR) understand and are able, willing, and likely to fully comply with the study procedures and restrictions defined in this protocol.
- Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol.
- Established chronic kidney disease (CKD), on dialysis, and requires treatment for hyperphosphatemia with a phosphate binder.
- Serum phosphorus levels after a washout period of up to 3 weeks as follows: Age <12 years: Serum phosphorus greater than (>) 6.0 mg/dL (1.94 mmol/L); Age 12 years and older: Serum phosphorus >5.5mg/dL (1.78mmol/L).
- Ability to provide written, signed and dated (personally or via an LAR) informed consent/and assent, as applicable, to participate in the study.
Exclusion Criteria:
- Current or recurrent disease (example [eg], cardiovascular, liver, unstable and uncontrolled gastrointestinal, malignancy, or other conditions) other than CKD or end-stage renal disease that could affect the action, absorption or disposition of the investigational product, or clinical or laboratory assessments.
- Current or relevant history of physical or psychiatric illness, any medical disorder (except for CKD or end-stage renal disease and related co-morbidities) that may require treatment or make the participant unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
- Unable to eat semi-solid foods or on Total Enteral Alimentation.
- Known or suspected intolerance or hypersensitivity to the investigational product(s), closely related compounds, or any of the stated ingredients.
- History of alcohol or other substance abuse within the last year.
- Current use of any medication (including over-the-counter, herbal, or homeopathic preparations) that could affect (improve or worsen) the condition being studied, or could affect the action, absorption, or disposition of the investigational product(s), or clinical or laboratory assessment.
- Weight and age of participant are outside of local applicable criteria for blood sample volume limits.
- Use of another investigational product within 30 days prior to receiving the first dose of investigational product.
Sites / Locations
- Centro Infantil Del Rinon S.R.L
- Hospital Luis Calvo Mackenna
- Hospital Dr. Sotero del Rio
- Fakultni nemocnice Ostrava
- University Hospital Motol
- Kinder-und Jugendklinik Erlangen
- Medizinische Hochschule Hannover
- Semmelweis Egyetem Altalanos Orvostudomanyi Kar
- Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
- Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar
- Uniwersytecki Dzieciecy Szpital Kliniczny
- Uniwersytecki Szpital Dzieciecy w Krakowie, Klinika Nefrologii Dzieciecej ze Stacja Dializ
- NZOZ tri-Medica
- Uniwersytecki Szpital Kliniczny
- Spitalul Clinic de Urgenta pentru Copii Sf. Maria
- Spitalul Clinic de Urgenta pentru Copii - Louis Turcanu
- Children City Clinical Hospital of Saint Vladimir
- Saint-Petersburg State Budgetary Healthcare Institution "Children City Hospital #1"
- State Budgetary Healthcare Instit. of Sverdiov Region "Regional Children Clinical Hosp #1"
- Cukurova University Faculty of Medicine Paediatric Nephrology
- Izmir Tepecik Training and Research Hospital
- Manisa Celal Bayar University Hafsa Sultan Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lanthanum Carbonate
Calcium Carbonate
Arm Description
Participants will receive lanthanum carbonate orally at a total daily dose of 1500 mg to 3000 mg divided and mixed equally between in three meals.
Participants will receive calcium carbonate orally at a total daily dose adjusted as appropriate, until the target serum phosphorus level is achieved or until a maximum daily dose of 6500 mg is reached.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01696279
Brief Title
A Study to Assess the Pharmacokinetics of Lanthanum Carbonate, Investigate and Compare the Efficacy, Safety and Tolerability of Lanthanum Carbonate With Calcium Carbonate in Hyperphosphataemic Children and Adolescents With Chronic Kidney Disease on Dialysis
Official Title
A 3-part Open-label Study to Assess the Pharmacokinetics of Lanthanum Carbonate, Compare the Efficacy, Safety and Tolerability of 8 Weeks of Treatment With Lanthanum Carbonate and Calcium Carbonate Using a Crossover Design and Investigate the Efficacy and Safety of 8 Months of Treatment With Lanthanum Carbonate in Hyperphosphataemic Children and Adolescents Aged 10 Years to <18 Years With Chronic Kidney Disease on Dialysis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
February 15, 2013 (Actual)
Primary Completion Date
November 16, 2018 (Actual)
Study Completion Date
November 16, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to summarize the percentage of participants achieving age-specific Kidney Disease Outcomes Quality Initiative (KDOQI) targets for serum phosphorus in hyperphosphatemic children and adolescents with chronic kidney disease (CKD) who are on dialysis, following 8 weeks of treatment with lanthanum carbonate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Hyperphosphatemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lanthanum Carbonate
Arm Type
Experimental
Arm Description
Participants will receive lanthanum carbonate orally at a total daily dose of 1500 mg to 3000 mg divided and mixed equally between in three meals.
Arm Title
Calcium Carbonate
Arm Type
Active Comparator
Arm Description
Participants will receive calcium carbonate orally at a total daily dose adjusted as appropriate, until the target serum phosphorus level is achieved or until a maximum daily dose of 6500 mg is reached.
Intervention Type
Drug
Intervention Name(s)
Lanthanum Carbonate
Other Intervention Name(s)
SPD405
Intervention Description
Lanthanum Carbonate 1500 mg to 3000 mg powder will be administered orally.
Intervention Type
Drug
Intervention Name(s)
Calcium Carbonate
Intervention Description
Calcium carbonate will be administered orally at a total daily dose based on standard clinical practice. The total daily dose may be adjusted as appropriate, until the target serum phosphorus level is achieved or until a maximum daily dose of 6500 mg is reached.
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
After 8 weeks of lanthanum carbonate administration in Part 2 and/or in Part 3
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving Age-Specific Kidney Disease Outcomes Quality Initiative (KDOQI) Targets for Serum Phosphate Level During Part 2
Description
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.
Time Frame
Up to 19 weeks
Title
Change From Baseline in Serum Phosphorus Levels Following Treatment With Lanthanum Carbonate After 8 Weeks
Description
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.
Time Frame
Baseline, Week 8 of lanthanum carbonate administration in Part 2 and/or in Part 3
Title
Change From Baseline in Calcium Levels Following Treatment With Lanthanum Carbonate After Week 8
Description
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.
Time Frame
Baseline, Week 8 of lanthanum carbonate administration in Part 2 and/or in Part 3
Title
Change From Baseline in Calcium-Phosphorus Product Levels Following Treatment With Lanthanum Carbonate After Week 8
Description
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.
Time Frame
Baseline, Week 8 of lanthanum carbonate administration in Part 2 and/or in Part 3
Title
Change From Baseline in Serum Phosphorus Levels Following Treatment With Calcium Carbonate After 8 Weeks and Lanthanum Carbonate After 8 Weeks During Part 2
Description
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.
Time Frame
Baseline, Week 8
Title
Change From Baseline in Calcium Levels Following Treatment With Calcium Carbonate After 8 Weeks and Lanthanum Carbonate After 8 Weeks During Part 2
Description
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.
Time Frame
Baseline, Week 8
Title
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
Description
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.
Time Frame
Baseline, Week 8
Title
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
Description
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.
Time Frame
Baseline, Week 8, 12, 16, 20, 24, 28 and Week 32
Title
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
Description
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.
Time Frame
Baseline, Week 8, 12, 16, 20, 24, 28 and Week 32
Title
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
Description
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.
Time Frame
Baseline, Week 8, 12, 16, 20, 24, 28 and Week 32
Title
Change From Baseline in Biochemical Bone Markers
Description
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.
Time Frame
Baseline, Week 8, Week 16 and EOS (up to 42 weeks)
Title
Change From Baseline in Biochemical Bone Markers for Tartrate-Resistant Acid Phosphatase (TRAP)
Description
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.
Time Frame
Baseline, Week 8, Week 16 and EOS (up to 42 weeks)
Title
Change From Baseline in Biochemical Bone Markers for Fibroblast Growth Factor 23 (FGF-23)
Description
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.
Time Frame
Baseline, Week 8, Week 16 and EOS (up to 42 weeks)
Title
Change From Baseline in Biochemical Bone Markers for Parathyroid Hormone (PTH)
Description
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.
Time Frame
Baseline, Week 8, Week 16 and EOS (up to 42 weeks)
Title
Change From Baseline in Biochemical Bone Markers for Fetuin-A
Description
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.
Time Frame
Baseline, Week 8, Week 16 and EOS (up to 42 weeks)
Title
Change From Baseline in Height
Description
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.
Time Frame
Baseline, Week 8, Week 16, and EOS (up to 42 weeks)
Title
Change From Baseline in Weight
Description
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.
Time Frame
Baseline, Week 8, Week 16, and EOS (up to 42 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 10 years to less than (<) 18 years of age at the time of consent.
Participant or parent/legally authorized representative (LAR) understand and are able, willing, and likely to fully comply with the study procedures and restrictions defined in this protocol.
Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol.
Established chronic kidney disease (CKD), on dialysis, and requires treatment for hyperphosphatemia with a phosphate binder.
Serum phosphorus levels after a washout period of up to 3 weeks as follows: Age <12 years: Serum phosphorus greater than (>) 6.0 mg/dL (1.94 mmol/L); Age 12 years and older: Serum phosphorus >5.5mg/dL (1.78mmol/L).
Ability to provide written, signed and dated (personally or via an LAR) informed consent/and assent, as applicable, to participate in the study.
Exclusion Criteria:
Current or recurrent disease (example [eg], cardiovascular, liver, unstable and uncontrolled gastrointestinal, malignancy, or other conditions) other than CKD or end-stage renal disease that could affect the action, absorption or disposition of the investigational product, or clinical or laboratory assessments.
Current or relevant history of physical or psychiatric illness, any medical disorder (except for CKD or end-stage renal disease and related co-morbidities) that may require treatment or make the participant unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
Unable to eat semi-solid foods or on Total Enteral Alimentation.
Known or suspected intolerance or hypersensitivity to the investigational product(s), closely related compounds, or any of the stated ingredients.
History of alcohol or other substance abuse within the last year.
Current use of any medication (including over-the-counter, herbal, or homeopathic preparations) that could affect (improve or worsen) the condition being studied, or could affect the action, absorption, or disposition of the investigational product(s), or clinical or laboratory assessment.
Weight and age of participant are outside of local applicable criteria for blood sample volume limits.
Use of another investigational product within 30 days prior to receiving the first dose of investigational product.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Centro Infantil Del Rinon S.R.L
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Hospital Luis Calvo Mackenna
City
Santiago
ZIP/Postal Code
7500539
Country
Chile
Facility Name
Hospital Dr. Sotero del Rio
City
Santiago
ZIP/Postal Code
8207257
Country
Chile
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava
ZIP/Postal Code
70852
Country
Czechia
Facility Name
University Hospital Motol
City
Prague 5
ZIP/Postal Code
15006
Country
Czechia
Facility Name
Kinder-und Jugendklinik Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Semmelweis Egyetem Altalanos Orvostudomanyi Kar
City
Budapest
State/Province
Bokay Janos
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Uniwersytecki Dzieciecy Szpital Kliniczny
City
Bialystok
ZIP/Postal Code
15-274
Country
Poland
Facility Name
Uniwersytecki Szpital Dzieciecy w Krakowie, Klinika Nefrologii Dzieciecej ze Stacja Dializ
City
Krakow
ZIP/Postal Code
30663
Country
Poland
Facility Name
NZOZ tri-Medica
City
Lodz
ZIP/Postal Code
93-338
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny
City
Wroclaw
ZIP/Postal Code
50556
Country
Poland
Facility Name
Spitalul Clinic de Urgenta pentru Copii Sf. Maria
City
Iasi
Country
Romania
Facility Name
Spitalul Clinic de Urgenta pentru Copii - Louis Turcanu
City
Timisoara
ZIP/Postal Code
300350
Country
Romania
Facility Name
Children City Clinical Hospital of Saint Vladimir
City
Moscow
ZIP/Postal Code
107014
Country
Russian Federation
Facility Name
Saint-Petersburg State Budgetary Healthcare Institution "Children City Hospital #1"
City
Saint-Petersburg
ZIP/Postal Code
198205
Country
Russian Federation
Facility Name
State Budgetary Healthcare Instit. of Sverdiov Region "Regional Children Clinical Hosp #1"
City
Yekaterinburg
ZIP/Postal Code
620143
Country
Russian Federation
Facility Name
Cukurova University Faculty of Medicine Paediatric Nephrology
City
Adana
ZIP/Postal Code
01330
Country
Turkey
Facility Name
Izmir Tepecik Training and Research Hospital
City
Izmir
ZIP/Postal Code
4500
Country
Turkey
Facility Name
Manisa Celal Bayar University Hafsa Sultan Hospital
City
Manisa
ZIP/Postal Code
45030
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
35236302
Citation
Wasilewska A, Murray RA, Sundberg A, Uddin S, Achenbach H, Shavkin A, Szabo T, Vergani A, Umeh O. An open-label phase 2 trial to assess the efficacy, safety and pharmacokinetics of lanthanum carbonate in hyperphosphatemic children and adolescents with chronic kidney disease undergoing dialysis. BMC Nephrol. 2022 Mar 2;23(1):84. doi: 10.1186/s12882-022-02688-9.
Results Reference
derived
Learn more about this trial
A Study to Assess the Pharmacokinetics of Lanthanum Carbonate, Investigate and Compare the Efficacy, Safety and Tolerability of Lanthanum Carbonate With Calcium Carbonate in Hyperphosphataemic Children and Adolescents With Chronic Kidney Disease on Dialysis
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