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

NCT ID: NCT01696279

Last Updated: 2021-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-15
• Study Completion Date: 2018-11-16

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lanthanum Carbonate

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.

Group Type: EXPERIMENTAL

Lanthanum Carbonate

Intervention Type: DRUG

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

Calcium Carbonate

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.

Group Type: ACTIVE_COMPARATOR

Calcium Carbonate

Intervention Type: 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.

Interventions

Lanthanum Carbonate

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

Intervention Type: DRUG

Calcium 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.

Intervention Type: DRUG

Other Intervention Names

SPD405

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Centro Infantil Del Rinon S.R.L

San Miguel de Tucumán, Tucumán Province, Argentina

Hospital Luis Calvo Mackenna

Santiago, , Chile

Hospital Dr. Sotero del Rio

Santiago, , Chile

Fakultni nemocnice Ostrava

Ostrava, , Czechia

University Hospital Motol

Prague, , Czechia

Kinder-und Jugendklinik Erlangen

Erlangen, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

Semmelweis Egyetem Altalanos Orvostudomanyi Kar

Budapest, Bokay Janos, Hungary

Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

Debrecen, , Hungary

Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar

Szeged, , Hungary

Uniwersytecki Dzieciecy Szpital Kliniczny

Bialystok, , Poland

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

Krakow, , Poland

NZOZ tri-Medica

Lodz, , Poland

Uniwersytecki Szpital Kliniczny

Wroclaw, , Poland

Spitalul Clinic de Urgenta pentru Copii Sf. Maria

Iași, , Romania

Spitalul Clinic de Urgenta pentru Copii - Louis Turcanu

Timișoara, , Romania

Children City Clinical Hospital of Saint Vladimir

Moscow, , Russia

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

Saint Petersburg, , Russia

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

Yekaterinburg, , Russia

Cukurova University Faculty of Medicine Paediatric Nephrology

Adana, , Turkey (Türkiye)

Izmir Tepecik Training and Research Hospital

Izmir, , Turkey (Türkiye)

Manisa Celal Bayar University Hafsa Sultan Hospital

Manisa, , Turkey (Türkiye)

Countries

Argentina; Chile; Czechia; Germany; Hungary; Poland; Romania; Russia; Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 35236302 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2012-000171-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SPD405-207

Identifier Type: -

Identifier Source: org_study_id