Chronic Kidney Disease, Hyperphosphatemia
Conditions
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.
Interventions
DRUGLanthanum Carbonate
Lanthanum Carbonate 1500 mg to 3000 mg powder will be administered orally.
DRUGCalcium Carbonate
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.
Sponsors
Shire
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 10 years to less than (\<) 18 years of age at the time of consent. 2. 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. 3. Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol. 4. Established chronic kidney disease (CKD), on dialysis, and requires treatment for hyperphosphatemia with a phosphate binder. 5. 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). 6. 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
1. 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. 2. 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. 3. Unable to eat semi-solid foods or on Total Enteral Alimentation. 4. Known or suspected intolerance or hypersensitivity to the investigational product(s), closely related compounds, or any of the stated ingredients. 5. History of alcohol or other substance abuse within the last year. 6. 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. 7. Weight and age of participant are outside of local applicable criteria for blood sample volume limits. 8. Use of another investigational product within 30 days prior to receiving the first dose of investigational product.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | After 8 weeks of lanthanum carbonate administration in Part 2 and/or in 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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Serum Phosphorus Levels Following Treatment With Lanthanum Carbonate After 8 Weeks | Baseline, Week 8 of lanthanum carbonate administration in Part 2 and/or in Part 3 | 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 | Baseline, Week 8 of lanthanum carbonate administration in Part 2 and/or in Part 3 | 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 | Baseline, Week 8 of lanthanum carbonate administration in Part 2 and/or in Part 3 | 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 | Baseline, Week 8 | 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 | Baseline, Week 8 | 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 | Baseline, Week 8 | 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 | Baseline, Week 8, 12, 16, 20, 24, 28 and Week 32 | 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 | Baseline, Week 8, 12, 16, 20, 24, 28 and Week 32 | 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. |
| Percentage of Participants Achieving Age-Specific Kidney Disease Outcomes Quality Initiative (KDOQI) Targets for Serum Phosphate Level During Part 2 | Up to 19 weeks | 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 Biochemical Bone Markers | Baseline, Week 8, Week 16 and EOS (up to 42 weeks) | 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) | Baseline, Week 8, Week 16 and EOS (up to 42 weeks) | 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) | Baseline, Week 8, Week 16 and EOS (up to 42 weeks) | 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) | Baseline, Week 8, Week 16 and EOS (up to 42 weeks) | 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 | Baseline, Week 8, Week 16 and EOS (up to 42 weeks) | 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 | Baseline, Week 8, Week 16, and EOS (up to 42 weeks) | 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 | Baseline, Week 8, Week 16, and EOS (up to 42 weeks) | 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. |
| 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 | Baseline, Week 8, 12, 16, 20, 24, 28 and Week 32 | 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. |
Countries
Argentina, Chile, Czechia, Germany, Hungary, Poland, Romania, Russia, Turkey (Türkiye)
Participant flow
Recruitment details
The study was conducted at 23 study centers between 15 February 2013 (first participant first visit) and 16 November 2018 (last participant last visit).
Pre-assignment details
It was a 3 part study (Part 1: Pharmacokinetic assessment, Part 2: \[Part 2a-calcium carbonate and lanthanum carbonate {crossover comparison} or Part 2b-lanthanum carbonate\], Part 3: lanthanum carbonate treatment for 6 months). Overall 63 participants enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Study was conducted in 3 parts, participants aged 10 to 12 years received 500 milligram (mg) and greater than (\>) 12 years received 1000 mg single dose of lanthanum carbonate oral powder respectively during part 1, followed by part 2 during which participants received calcium carbonate tablet for 8 weeks until a maximum daily dose of 6500 mg was reached (part 2a-Treatment period 1) and then received lanthanum carbonate oral powder for 8 weeks until a daily dose of 1500 mg was reached (part 2a-Treatment period 2). Eligible participants received lanthanum carbonate oral powder for 8 weeks at a daily dose of 1500 mg, which was titrated bi-weekly until a daily dose of 3000 mg was achieved (part 2b). Participants who completed part 2 continued the same treatment for additional 6 months during the part 3. | 63 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Part 1: Single Dose Lanthanum Carbonate | Kidney Transplant | 1 | 0 | 0 | 0 |
| Part 2a: Calcium Carbonate + Lanthanum | Adverse Event | 0 | 5 | 0 | 0 |
| Part 2a: Calcium Carbonate + Lanthanum | Kidney Transplant | 0 | 7 | 0 | 0 |
| Part 2a: Calcium Carbonate + Lanthanum | Non-Compliance with Study Drug | 0 | 2 | 0 | 0 |
| Part 2a: Calcium Carbonate + Lanthanum | Other (Unspecified) | 0 | 3 | 0 | 0 |
| Part 2a: Calcium Carbonate + Lanthanum | Protocol Violation | 0 | 1 | 0 | 0 |
| Part 2a: Calcium Carbonate + Lanthanum | Withdrawal by Subject | 0 | 1 | 0 | 0 |
| Part 2b: Lanthanum Carbonate (8 Weeks) | Kidney Transplant | 0 | 0 | 1 | 0 |
| Part 3: Lanthanum Carbonate (6 Months) | Kidney transplant | 0 | 0 | 0 | 6 |
| Part 3: Lanthanum Carbonate (6 Months) | Missing | 0 | 0 | 0 | 1 |
| Part 3: Lanthanum Carbonate (6 Months) | Other (Unspecified) | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Continuous | 13.1 Year STANDARD_DEVIATION 2.65 |
| Age, Customized Age group: ≥10 to <12 years | 11 Participants |
| Age, Customized Age group: < 10 years | 3 Participants |
| Age, Customized Age group: ≥12 to <18 years | 49 Participants |
| Age, Customized Age group: ≥18 years | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 58 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants |
| Race/Ethnicity, Customized Multiple | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized White | 61 Participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 53 | 0 / 52 |
| other Total, other adverse events | 2 / 20 | 10 / 53 | 20 / 52 |
| serious Total, serious adverse events | 0 / 20 | 9 / 53 | 19 / 52 |
Outcome results
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.
Time frame: After 8 weeks of lanthanum carbonate administration in Part 2 and/or in Part 3
Population: Per-protocol set 2 (PP2) included participants who had taken at least 1 dose of investigational product and completed 8 weeks of treatment with lanthanum carbonate and who had serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of participants achieving age-specific KDOQI target.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 2 + Part 3: Lanthanum Carbonate | 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) | 50 Percentage of participants |
Secondary
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.
Time frame: Baseline, Week 8, Week 16 and EOS (up to 42 weeks)
Population: PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2 + Part 3: Lanthanum Carbonate | Change From Baseline in Biochemical Bone Markers | ALP : Change at Week 8 | -0.78 microgram per liter (ug/L) | Standard Error 8.503 |
| Part 2 + Part 3: Lanthanum Carbonate | Change From Baseline in Biochemical Bone Markers | Osteocalcin: Change at Week 8 | 8.2 microgram per liter (ug/L) | Standard Error 20.24 |
| Part 2 + Part 3: Lanthanum Carbonate | Change From Baseline in Biochemical Bone Markers | Sclerostin: Change at Week 8 | 0.146 microgram per liter (ug/L) | Standard Error 0.138 |
| Part 2: Lanthanum Carbonate | Change From Baseline in Biochemical Bone Markers | Sclerostin: Change at EOS | -0.051 microgram per liter (ug/L) | Standard Error 0.1037 |
| Part 2: Lanthanum Carbonate | Change From Baseline in Biochemical Bone Markers | Sclerostin: Change at Week 16 | -0.062 microgram per liter (ug/L) | Standard Error 0.0946 |
| Part 2: Lanthanum Carbonate | Change From Baseline in Biochemical Bone Markers | Osteocalcin: Change at Week 16 | 10.3 microgram per liter (ug/L) | Standard Error 21.57 |
| Part 2: Lanthanum Carbonate | Change From Baseline in Biochemical Bone Markers | Osteocalcin: Change at EOS | 94.0 microgram per liter (ug/L) | Standard Error 32.6 |
| Part 2: Lanthanum Carbonate | Change From Baseline in Biochemical Bone Markers | ALP : Change at Week 16 | 31.86 microgram per liter (ug/L) | Standard Error 16.334 |
| Part 2: Lanthanum Carbonate | Change From Baseline in Biochemical Bone Markers | ALP : Change at EOS | 59.12 microgram per liter (ug/L) | Standard Error 20.822 |
Secondary
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.
Time frame: Baseline, Week 8, Week 16 and EOS (up to 42 weeks)
Population: PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2 + Part 3: Lanthanum Carbonate | Change From Baseline in Biochemical Bone Markers for Fetuin-A | Changed at Week 8 | -0.006 gram per liter (g/L) | Standard Error 0.0301 |
| Part 2: Lanthanum Carbonate | Change From Baseline in Biochemical Bone Markers for Fetuin-A | Change at Week 16 | 0.037 gram per liter (g/L) | Standard Error 0.036 |
| Part 2: Lanthanum Carbonate | Change From Baseline in Biochemical Bone Markers for Fetuin-A | Change at EOS | 0.039 gram per liter (g/L) | Standard Error 0.0273 |
Secondary
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.
Time frame: Baseline, Week 8, Week 16 and EOS (up to 42 weeks)
Population: PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2 + Part 3: Lanthanum Carbonate | Change From Baseline in Biochemical Bone Markers for Fibroblast Growth Factor 23 (FGF-23) | Change at Week 8 | 5130.3 relative unit per milliliter (RU/ml) | Standard Error 5232.21 |
| Part 2: Lanthanum Carbonate | Change From Baseline in Biochemical Bone Markers for Fibroblast Growth Factor 23 (FGF-23) | Change at EOS | -251.1 relative unit per milliliter (RU/ml) | Standard Error 1736.51 |
| Part 2: Lanthanum Carbonate | Change From Baseline in Biochemical Bone Markers for Fibroblast Growth Factor 23 (FGF-23) | Change at Week 16 | -8162.4 relative unit per milliliter (RU/ml) | Standard Error 5274.6 |
Secondary
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.
Time frame: Baseline, Week 8, Week 16 and EOS (up to 42 weeks)
Population: PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2 + Part 3: Lanthanum Carbonate | Change From Baseline in Biochemical Bone Markers for Parathyroid Hormone (PTH) | Change at Week 8 | -7.132 picomole per litre (pmol/L) | Standard Error 9.7669 |
| Part 2: Lanthanum Carbonate | Change From Baseline in Biochemical Bone Markers for Parathyroid Hormone (PTH) | Change at Week 16 | 16.273 picomole per litre (pmol/L) | Standard Error 12.5441 |
| Part 2: Lanthanum Carbonate | Change From Baseline in Biochemical Bone Markers for Parathyroid Hormone (PTH) | Change at EOS | 59.801 picomole per litre (pmol/L) | Standard Error 16.3097 |
Secondary
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.
Time frame: Baseline, Week 8, Week 16 and EOS (up to 42 weeks)
Population: PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2 + Part 3: Lanthanum Carbonate | Change From Baseline in Biochemical Bone Markers for Tartrate-Resistant Acid Phosphatase (TRAP) | Change at Week 8 | -1.71 unit per liter (U/L) | Standard Error 1.141 |
| Part 2: Lanthanum Carbonate | Change From Baseline in Biochemical Bone Markers for Tartrate-Resistant Acid Phosphatase (TRAP) | Change at Week 16 | 1.95 unit per liter (U/L) | Standard Error 1.173 |
| Part 2: Lanthanum Carbonate | Change From Baseline in Biochemical Bone Markers for Tartrate-Resistant Acid Phosphatase (TRAP) | Change at EOS | 4.65 unit per liter (U/L) | Standard Error 1.934 |
Secondary
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.
Time frame: Baseline, Week 8, 12, 16, 20, 24, 28 and Week 32
Population: PP2 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of treatment with lanthanum carbonate and who had serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of participants achieving age-specific KDOQI target.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2 + Part 3: Lanthanum Carbonate | 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 at Week 12 | -0.045 millimole per liter (mmol/L) | Standard Error 0.0475 |
| Part 2 + Part 3: Lanthanum Carbonate | 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 at Week 24 | -0.010 millimole per liter (mmol/L) | Standard Error 0.045 |
| Part 2 + Part 3: Lanthanum Carbonate | 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 at Week 28 | 0.049 millimole per liter (mmol/L) | Standard Error 0.0623 |
| Part 2 + Part 3: Lanthanum Carbonate | 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 at Week 8 | -0.001 millimole per liter (mmol/L) | Standard Error 0.0363 |
| Part 2 + Part 3: Lanthanum Carbonate | 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 at Week 16 | -0.034 millimole per liter (mmol/L) | Standard Error 0.0534 |
| Part 2 + Part 3: Lanthanum Carbonate | 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 at Week 20 | 0.003 millimole per liter (mmol/L) | Standard Error 0.0511 |
| Part 2 + Part 3: Lanthanum Carbonate | 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 at Week 32 | -0.127 millimole per liter (mmol/L) | Standard Error 0.0773 |
Secondary
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.
Time frame: Baseline, Week 8
Population: PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 2 + Part 3: Lanthanum Carbonate | Change From Baseline in Calcium Levels Following Treatment With Calcium Carbonate After 8 Weeks and Lanthanum Carbonate After 8 Weeks During Part 2 | 0.058 millimole per liter (mmol/L) | Standard Error 0.0554 |
| Part 2: Lanthanum Carbonate | Change From Baseline in Calcium Levels Following Treatment With Calcium Carbonate After 8 Weeks and Lanthanum Carbonate After 8 Weeks During Part 2 | -0.009 millimole per liter (mmol/L) | Standard Error 0.0574 |
Secondary
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.
Time frame: Baseline, Week 8 of lanthanum carbonate administration in Part 2 and/or in Part 3
Population: PP2 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of treatment with lanthanum carbonate and who had serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of participants achieving age-specific KDOQI target.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 2 + Part 3: Lanthanum Carbonate | Change From Baseline in Calcium Levels Following Treatment With Lanthanum Carbonate After Week 8 | -0.001 millimole per liter (mmol/L) | Standard Error 0.0363 |
Secondary
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.
Time frame: Baseline, Week 8, 12, 16, 20, 24, 28 and Week 32
Population: PP2 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of treatment with lanthanum carbonate and who had serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of participants achieving age-specific KDOQI target.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2 + Part 3: Lanthanum Carbonate | 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 at Week 12 | -0.783 mmol^2/L^2 | Standard Error 0.2535 |
| Part 2 + Part 3: Lanthanum Carbonate | 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 at Week 8 | -0.577 mmol^2/L^2 | Standard Error 0.2464 |
| Part 2 + Part 3: Lanthanum Carbonate | 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 at Week 16 | -0.575 mmol^2/L^2 | Standard Error 0.3023 |
| Part 2 + Part 3: Lanthanum Carbonate | 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 at Week 20 | -0.362 mmol^2/L^2 | Standard Error 0.2711 |
| Part 2 + Part 3: Lanthanum Carbonate | 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 at Week 24 | -0.578 mmol^2/L^2 | Standard Error 0.3459 |
| Part 2 + Part 3: Lanthanum Carbonate | 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 at Week 28 | -0.326 mmol^2/L^2 | Standard Error 0.3767 |
| Part 2 + Part 3: Lanthanum Carbonate | 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 at Week 32 | -0.570 mmol^2/L^2 | Standard Error 0.3624 |
Secondary
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.
Time frame: Baseline, Week 8
Population: PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 2 + Part 3: Lanthanum Carbonate | 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 | -0.966 mmol^2/L^2 | Standard Error 0.4084 |
| Part 2: Lanthanum Carbonate | 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 | -0.669 mmol^2/L^2 | Standard Error 0.3834 |
Secondary
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.
Time frame: Baseline, Week 8 of lanthanum carbonate administration in Part 2 and/or in Part 3
Population: PP2 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of treatment with lanthanum carbonate and who had serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of participants achieving age-specific KDOQI target.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 2 + Part 3: Lanthanum Carbonate | Change From Baseline in Calcium-Phosphorus Product Levels Following Treatment With Lanthanum Carbonate After Week 8 | -0.577 mmol^2/L^2 | Standard Error 0.2464 |
Secondary
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.
Time frame: Baseline, Week 8, Week 16, and EOS (up to 42 weeks)
Population: PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2 + Part 3: Lanthanum Carbonate | Change From Baseline in Height | Change at Week 8 | 0.7 centimeter (cm) | Standard Error 0.39 |
| Part 2: Lanthanum Carbonate | Change From Baseline in Height | Change at Week 16 | 0.6 centimeter (cm) | Standard Error 0.25 |
| Part 2: Lanthanum Carbonate | Change From Baseline in Height | Change at EOS | 1.3 centimeter (cm) | Standard Error 0.46 |
Secondary
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.
Time frame: Baseline, Week 8, 12, 16, 20, 24, 28 and Week 32
Population: PP2 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of treatment with lanthanum carbonate and who had serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of participants achieving age-specific KDOQI target.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2 + Part 3: Lanthanum Carbonate | 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 at Week 8 | -0.334 millimole per liter (mmol/L) | Standard Deviation 0.1035 |
| Part 2 + Part 3: Lanthanum Carbonate | 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 at Week 12 | -0.416 millimole per liter (mmol/L) | Standard Deviation 0.0912 |
| Part 2 + Part 3: Lanthanum Carbonate | 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 at Week 16 | -0.314 millimole per liter (mmol/L) | Standard Deviation 0.1278 |
| Part 2 + Part 3: Lanthanum Carbonate | 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 at Week 20 | -0.316 millimole per liter (mmol/L) | Standard Deviation 0.1055 |
| Part 2 + Part 3: Lanthanum Carbonate | 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 at Week 24 | -0.322 millimole per liter (mmol/L) | Standard Deviation 0.1356 |
| Part 2 + Part 3: Lanthanum Carbonate | 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 at Week 28 | -0.236 millimole per liter (mmol/L) | Standard Deviation 0.1491 |
| Part 2 + Part 3: Lanthanum Carbonate | 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 at Week 32 | -0.143 millimole per liter (mmol/L) | Standard Deviation 0.1558 |
Secondary
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.
Time frame: Baseline, Week 8
Population: PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 2 + Part 3: Lanthanum Carbonate | Change From Baseline in Serum Phosphorus Levels Following Treatment With Calcium Carbonate After 8 Weeks and Lanthanum Carbonate After 8 Weeks During Part 2 | -0.520 millimole per liter (mmol/L) | Standard Error 0.1786 |
| Part 2: Lanthanum Carbonate | Change From Baseline in Serum Phosphorus Levels Following Treatment With Calcium Carbonate After 8 Weeks and Lanthanum Carbonate After 8 Weeks During Part 2 | -0.467 millimole per liter (mmol/L) | Standard Error 0.1312 |
Secondary
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.
Time frame: Baseline, Week 8 of lanthanum carbonate administration in Part 2 and/or in Part 3
Population: PP2 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of treatment with lanthanum carbonate and who had serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of participants achieving age-specific KDOQI target.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 2 + Part 3: Lanthanum Carbonate | Change From Baseline in Serum Phosphorus Levels Following Treatment With Lanthanum Carbonate After 8 Weeks | -0.334 millimoles per liter (mmol/L) | Standard Error 0.1035 |
Secondary
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.
Time frame: Baseline, Week 8, Week 16, and EOS (up to 42 weeks)
Population: PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2 + Part 3: Lanthanum Carbonate | Change From Baseline in Weight | Change at Week 8 | 1.18 kilogram (Kg) | Standard Error 0.524 |
| Part 2: Lanthanum Carbonate | Change From Baseline in Weight | Change at Week 16 | 1.09 kilogram (Kg) | Standard Error 0.358 |
| Part 2: Lanthanum Carbonate | Change From Baseline in Weight | Change at EOS | 2.86 kilogram (Kg) | Standard Error 0.606 |
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.
Time frame: Up to 19 weeks
Population: Per Protocol Set 1 (PP1) included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 2 + Part 3: Lanthanum Carbonate | Percentage of Participants Achieving Age-Specific Kidney Disease Outcomes Quality Initiative (KDOQI) Targets for Serum Phosphate Level During Part 2 | 58.8 Percentage of participants |
| Part 2: Lanthanum Carbonate | Percentage of Participants Achieving Age-Specific Kidney Disease Outcomes Quality Initiative (KDOQI) Targets for Serum Phosphate Level During Part 2 | 70.6 Percentage of participants |