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Chronic Kidney DiseasePhase 2NCT01696279

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

A Phase 2 study testing Lanthanum Carbonate and Calcium Carbonate in people with Chronic Kidney Disease and Hyperphosphatemia, run by Shire at 22 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 10 to 17 years
Conditions the study is for
Chronic Kidney Disease, Hyperphosphatemia
What is being tested?
Lanthanum Carbonate and Calcium Carbonate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
22 sitesin 9 countries
Study dates
15 Feb 2013to 16 Nov 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

22 sites in 9 countries.

22 sites in 9 countries

Poland4 sites

  • Uniwersytecki Dzieciecy Szpital Kliniczny

    Bialystok, 15-274

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

    Krakow, 30663

  • NZOZ tri-Medica

    Lodz, 93-338

  • Uniwersytecki Szpital Kliniczny

    Wroclaw, 50556

Other trials in Poland

Hungary3 sites

  • Semmelweis Egyetem Altalanos Orvostudomanyi Kar

    Budapest, Bokay Janos, 1083

  • Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

    Debrecen, 4032

  • Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar

    Szeged, 6720

Other trials in Hungary

Russia3 sites

  • Children City Clinical Hospital of Saint Vladimir

    Moscow, 107014

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

    Saint Petersburg, 198205

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

    Yekaterinburg, 620143

Other trials in Russia

Turkey (Türkiye)3 sites

  • Cukurova University Faculty of Medicine Paediatric Nephrology

    Adana, 01330

  • Izmir Tepecik Training and Research Hospital

    Izmir, 4500

  • Manisa Celal Bayar University Hafsa Sultan Hospital

    Manisa, 45030

Other trials in Turkey (Türkiye)

Chile2 sites

  • Hospital Luis Calvo Mackenna

    Santiago, 7500539

  • Hospital Dr. Sotero del Rio

    Santiago, 8207257

Other trials in Chile

Czechia2 sites

  • Fakultni nemocnice Ostrava

    Ostrava, 70852

  • University Hospital Motol

    Prague, 15006

Other trials in Czechia

Germany2 sites

  • Kinder-und Jugendklinik Erlangen

    Erlangen, 91054

  • Medizinische Hochschule Hannover

    Hanover, 30625

Other trials in Germany

Romania2 sites

  • Spitalul Clinic de Urgenta pentru Copii Sf. Maria

    Iași

  • Spitalul Clinic de Urgenta pentru Copii - Louis Turcanu

    Timișoara, 300350

Other trials in Romania

Argentina1 site

  • Centro Infantil Del Rinon S.R.L

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

About this study

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

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.

Being tested
Lanthanum Carbonate, Calcium Carbonate
Medical subject headings
Renal Insufficiency, Chronic, Hyperphosphatemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lanthanum CarbonateDrug

    Also called SPD405

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

  • Calcium CarbonateDrug

    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.

Study groups in NCT01696279
Study groupRoleWhat they receive
Lanthanum CarbonateExperimentalParticipants will receive lanthanum carbonate orally at a total daily dose of 1500 mg to 3000 mg divided and mixed equally between in three meals.
Receives: Drug: Lanthanum Carbonate
Calcium CarbonateActive comparatorParticipants 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.
Receives: Drug: Calcium Carbonate

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (17)

  1. 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.

    Measured: Up to 19 weeks

  2. 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.

    Measured: Baseline, Week 8 of lanthanum carbonate administration in Part 2 and/or in Part 3

  3. 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.

    Measured: Baseline, Week 8 of lanthanum carbonate administration in Part 2 and/or in Part 3

  4. 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.

    Measured: Baseline, Week 8 of lanthanum carbonate administration in Part 2 and/or in Part 3

  5. 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.

    Measured: Baseline, Week 8

  6. 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.

    Measured: Baseline, Week 8

  7. 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.

    Measured: Baseline, Week 8

  8. 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.

    Measured: Baseline, Week 8, 12, 16, 20, 24, 28 and Week 32

  9. 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.

    Measured: Baseline, Week 8, 12, 16, 20, 24, 28 and Week 32

  10. 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.

    Measured: Baseline, Week 8, 12, 16, 20, 24, 28 and Week 32

  11. 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.

    Measured: Baseline, Week 8, Week 16 and EOS (up to 42 weeks)

  12. 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.

    Measured: Baseline, Week 8, Week 16 and EOS (up to 42 weeks)

  13. 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.

    Measured: Baseline, Week 8, Week 16 and EOS (up to 42 weeks)

  14. 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.

    Measured: Baseline, Week 8, Week 16 and EOS (up to 42 weeks)

  15. 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.

    Measured: Baseline, Week 8, Week 16 and EOS (up to 42 weeks)

  16. 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.

    Measured: Baseline, Week 8, Week 16, and EOS (up to 42 weeks)

  17. 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.

    Measured: Baseline, Week 8, Week 16, and EOS (up to 42 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2012 (estimated)
  2. Study start15 Feb 2013
  3. Primary completion16 Nov 2018
  4. Study completion16 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01696279
Sponsor's protocol ID
SPD405-207
Other IDs
2012-000171-17
Status last verified
May 2021
First submitted
26 Sep 2012
Last updated
10 Jun 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 35236302

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lanthanum Carbonate and Calcium Carbonate in people with Chronic Kidney Disease and Hyperphosphatemia, run by Shire at 22 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Poland, Hungary, Russia, Turkey (Türkiye), Chile and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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) (time frame: After 8 weeks of lanthanum carbonate administration in Part 2 and/or in Part 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01696279, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2021; AzTrials last refreshed its copy on 8 Nov 2026.

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