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

NCT01696279 | Completed Phase 2 Results

• 2 other identifiers: SPD405-2072012-000171-17
• Study Type: interventional
• Target: 63
• Locations: 9 countries
• Sites: 22

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.

Conditions

Chronic Kidney Disease; Hyperphosphatemia

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Age-Specific Kidney Disease Outcomes Quality Initiative (KDOQI) Targets for Serum Phosphate Level Following 8 Weeks of Lanthanum Carbonate Administration (Part 2 + Part 3)

  KDOQI serum phosphorus targets were defined for: Adolescents aged greater than or equal to (\>=) 12 to less than (\<) 18 years to be less than or equal to (\<=) 5.5 milligrams per deciliter (mg/dL) (1.78 millimoles per liter \[mmol/L\]); Children aged \>=10 years to \<12 years to be \<= 6.0 mg/dL (1.94 mmol/L). Percentage of participants achieving age-specific KDOQI targets for serum phosphate level was reported only for the participants who had received lanthanum carbonate during part 2 or part 3. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.

  After 8 weeks of lanthanum carbonate administration in Part 2 and/or in Part 3

Secondary Outcomes (17)

• Percentage of Participants Achieving Age-Specific Kidney Disease Outcomes Quality Initiative (KDOQI) Targets for Serum Phosphate Level During Part 2

  Up to 19 weeks

• 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

• 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

• 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

• 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

Study Arms (2)

Lanthanum Carbonate

EXPERIMENTAL

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.

Drug: Lanthanum Carbonate

Calcium Carbonate

ACTIVE COMPARATOR

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.

Drug: Calcium Carbonate

Interventions

Lanthanum Carbonate DRUG

Lanthanum Carbonate 1500 mg to 3000 mg powder will be administered orally.

Also known as: SPD405

Lanthanum Carbonate

Calcium Carbonate DRUG

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.

Calcium Carbonate

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shire: lead

Study Sites (22)

Centro Infantil Del Rinon S.R.L

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Hospital Luis Calvo Mackenna

Santiago, 7500539, Chile

Location

Hospital Dr. Sotero del Rio

Santiago, 8207257, Chile

Location

Fakultni nemocnice Ostrava

Ostrava, 70852, Czechia

Location

University Hospital Motol

Prague, 15006, Czechia

Location

Kinder-und Jugendklinik Erlangen

Erlangen, 91054, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Semmelweis Egyetem Altalanos Orvostudomanyi Kar

Budapest, Bokay Janos, 1083, Hungary

Location

Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

Debrecen, 4032, Hungary

Location

Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar

Szeged, 6720, Hungary

Location

Uniwersytecki Dzieciecy Szpital Kliniczny

Bialystok, 15-274, Poland

Location

Uniwersytecki Szpital Dzieciecy w Krakowie, Klinika Nefrologii Dzieciecej ze Stacja Dializ

Krakow, 30663, Poland

Location

NZOZ tri-Medica

Lodz, 93-338, Poland

Location

Uniwersytecki Szpital Kliniczny

Wroclaw, 50556, Poland

Location

Spitalul Clinic de Urgenta pentru Copii Sf. Maria

Iași, Romania

Location

Spitalul Clinic de Urgenta pentru Copii - Louis Turcanu

Timișoara, 300350, Romania

Location

Children City Clinical Hospital of Saint Vladimir

Moscow, 107014, Russia

Location

Saint-Petersburg State Budgetary Healthcare Institution "Children City Hospital #1"

Saint Petersburg, 198205, Russia

Location

State Budgetary Healthcare Instit. of Sverdiov Region "Regional Children Clinical Hosp #1"

Yekaterinburg, 620143, Russia

Location

Cukurova University Faculty of Medicine Paediatric Nephrology

Adana, 01330, Turkey (Türkiye)

Location

Izmir Tepecik Training and Research Hospital

Izmir, 4500, Turkey (Türkiye)

Location

Manisa Celal Bayar University Hafsa Sultan Hospital

Manisa, 45030, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 35236302 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperphosphatemia

Interventions

lanthanum carbonate; Calcium Carbonate

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals

Limitations and Caveats

Data was analyzed and presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for Part 2 and 3 in the entire study and separately for Part 1.

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2012
• First Posted: October 1, 2012
• Study Start: February 15, 2013
• Primary Completion: November 16, 2018
• Study Completion: November 16, 2018
• Last Updated: June 10, 2021
• Results First Posted: January 2, 2020

Record last verified: 2021-05

Locations

TU (3); AR (1); PL (4); RU (3); HU (3); CL (2); CZ (2); RO (2); DE (2)