Clinical trial NCT01696279: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Kidney Disease
Hyperphosphatemia
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2012-10-01
Enrollment: 63
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: After 8 weeks of lanthanum carbonate administration in Part 2 and/or in Part 3
Secondary outcomes:
measure: Percentage of Participants Achieving Age-Specific Kidney Disease Outcomes Quality Initiative (KDOQI) Targets for Serum Phosphate Level During Part 2
timeFrame: Up to 19 weeks
measure: Change From Baseline in Serum Phosphorus Levels Following Treatment With Lanthanum Carbonate After 8 Weeks
timeFrame: Baseline, Week 8 of lanthanum carbonate administration in Part 2 and/or in Part 3
measure: Change From Baseline in Calcium Levels Following Treatment With Lanthanum Carbonate After Week 8
timeFrame: Baseline, Week 8 of lanthanum carbonate administration in Part 2 and/or in Part 3
measure: Change From Baseline in Calcium-Phosphorus Product Levels Following Treatment With Lanthanum Carbonate After Week 8
timeFrame: Baseline, Week 8 of lanthanum carbonate administration in Part 2 and/or in Part 3
measure: Change From Baseline in Serum Phosphorus Levels Following Treatment With Calcium Carbonate After 8 Weeks and Lanthanum Carbonate After 8 Weeks During Part 2
timeFrame: Baseline, Week 8
measure: Change From Baseline in Calcium Levels Following Treatment With Calcium Carbonate After 8 Weeks and Lanthanum Carbonate After 8 Weeks During Part 2
timeFrame: Baseline, Week 8
measure: 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
timeFrame: Baseline, Week 8
measure: 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
timeFrame: Baseline, Week 8, 12, 16, 20, 24, 28 and Week 32
measure: 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
timeFrame: Baseline, Week 8, 12, 16, 20, 24, 28 and Week 32
measure: 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
timeFrame: Baseline, Week 8, 12, 16, 20, 24, 28 and Week 32
measure: Change From Baseline in Biochemical Bone Markers
timeFrame: Baseline, Week 8, Week 16 and EOS (up to 42 weeks)
measure: Change From Baseline in Biochemical Bone Markers for Tartrate-Resistant Acid Phosphatase (TRAP)
timeFrame: Baseline, Week 8, Week 16 and EOS (up to 42 weeks)
measure: Change From Baseline in Biochemical Bone Markers for Fibroblast Growth Factor 23 (FGF-23)
timeFrame: Baseline, Week 8, Week 16 and EOS (up to 42 weeks)
measure: Change From Baseline in Biochemical Bone Markers for Parathyroid Hormone (PTH)
timeFrame: Baseline, Week 8, Week 16 and EOS (up to 42 weeks)
measure: Change From Baseline in Biochemical Bone Markers for Fetuin-A
timeFrame: Baseline, Week 8, Week 16 and EOS (up to 42 weeks)
measure: Change From Baseline in Height
timeFrame: Baseline, Week 8, Week 16, and EOS (up to 42 weeks)
measure: Change From Baseline in Weight
timeFrame: Baseline, Week 8, Week 16, and EOS (up to 42 weeks)
Other outcomes:
Locations:
city: San Miguel de Tucuman
country: Argentina
facility: Centro Infantil Del Rinon S.R.L
state: Tucuman
city: Santiago
country: Chile
facility: Hospital Luis Calvo Mackenna
city: Santiago
country: Chile
facility: Hospital Dr. Sotero del Rio
city: Ostrava
country: Czechia
facility: Fakultni nemocnice Ostrava
city: Prague 5
country: Czechia
facility: University Hospital Motol
city: Erlangen
country: Germany
facility: Kinder-und Jugendklinik Erlangen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Altalanos Orvostudomanyi Kar
state: Bokay Janos
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar
city: Bialystok
country: Poland
facility: Uniwersytecki Dzieciecy Szpital Kliniczny
city: Krakow
country: Poland
facility: Uniwersytecki Szpital Dzieciecy w Krakowie, Klinika Nefrologii Dzieciecej ze Stacja Dializ
city: Lodz
country: Poland
facility: NZOZ tri-Medica
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny
city: Iasi
country: Romania
facility: Spitalul Clinic de Urgenta pentru Copii Sf. Maria
city: Timisoara
country: Romania
facility: Spitalul Clinic de Urgenta pentru Copii - Louis Turcanu
city: Moscow
country: Russian Federation
facility: Children City Clinical Hospital of Saint Vladimir
city: Saint-Petersburg
country: Russian Federation
facility: Saint-Petersburg State Budgetary Healthcare Institution "Children City Hospital #1"
city: Yekaterinburg
country: Russian Federation
facility: State Budgetary Healthcare Instit. of Sverdiov Region "Regional Children Clinical Hosp #1"
city: Adana
country: Turkey
facility: Cukurova University Faculty of Medicine Paediatric Nephrology
city: Izmir
country: Turkey
facility: Izmir Tepecik Training and Research Hospital
city: Manisa
country: Turkey
facility: Manisa Celal Bayar University Hafsa Sultan Hospital
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
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.