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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

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ClinicalTrials.gov Identifier: NCT01696279
Recruitment Status : Completed
First Posted : October 1, 2012
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Shire

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Hyperphosphatemia Drug: Lanthanum Carbonate Drug: Calcium Carbonate Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 23, 2013
Actual Primary Completion Date : November 16, 2018
Actual Study Completion Date : November 16, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: Lanthanum Carbonate
Lanthanum Carbonate 1500 mg to 3000 mg powder will be administered orally.
Other Name: SPD405

Active Comparator: 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.
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.




Primary Outcome Measures :
  1. Percentage of Participants Achieving age-Specific Kidney Disease Outcomes Quality Initiative (KDOQI) Targets for Serum Phosphate Level [ Time Frame: Week 19 ]
    The KDOQI serum phosphorus targets are defined as: Adolescents aged greater than or equal to (>=) 12-less than (<) 18 years: 5.5 milligrams per deciliter (mg/dL) (1.78 millimoles per liter [mmol/L]); Children aged 10 years -<12 years: 6.0 mg/dL (1.94 mmol/L). Percentage of participants achieving age-specific KDOQI targets for serum phosphate level will be reported.


Secondary Outcome Measures :
  1. Percentage of Participants With Serum Phosphorus Levels Below the age-Specific Kidney Disease Outcomes Quality Initiative (KDOQI) Targets [ Time Frame: Baseline up to 19 weeks ]
    The KDOQI serum phosphorus targets are defined as: Adolescents aged 12-<18 years: 5.5mg/dL (1.78mmol/L); Children aged 10 years -<12 years: 6.0mg/dL (1.94mmol/L). Percentage of participants with serum phosphorus levels below the age-specific KDOQI targets will be reported.

  2. Change From Baseline in Serum Phosphorus Levels Following Treatment With Lanthanum Carbonate for 8 Weeks [ Time Frame: Baseline, Week 19 ]
    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 will be assessed.

  3. Change From Baseline in Calcium Levels Following Treatment With Lanthanum Carbonate for 8 Weeks [ Time Frame: Baseline, Week 19 ]
    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 will be assessed.

  4. Change From Baseline in Calcium-Phosphorus Product Levels Following Treatment With Lanthanum Carbonate for 8 Weeks [ Time Frame: Baseline, Week 19 ]
    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 will be assessed.

  5. Change From Baseline in Serum Phosphorus Levels Following Treatment With Calcium Carbonate for 8 Weeks and Lanthanum Carbonate for 8 Weeks [ Time Frame: Baseline, Week 8 and 19 ]
    Changes from baseline in serum phosphorus levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with calcium carbonate for 8 weeks and lanthanum carbonate for 8 weeks will be assessed.

  6. Change From Baseline in Calcium Levels Following Treatment With Calcium Carbonate for 8 Weeks and Lanthanum Carbonate for 8 Weeks [ Time Frame: Baseline, Week 8 and 19 ]
    Changes from baseline in calcium levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with calcium carbonate for 8 weeks and lanthanum carbonate for 8 weeks will be assessed.

  7. Change From Baseline in Calcium-Phosphorus Product Levels Following Treatment With Calcium Carbonate for 8 Weeks and Lanthanum Carbonate for 8 Weeks [ Time Frame: Baseline, Week 8 and 19 ]
    Changes from baseline in calcium-phosphorus product levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with calcium carbonate for 8 weeks and lanthanum carbonate for 8 weeks will be assessed.

  8. Change From Baseline in Serum Phosphorus Levels at the Last Visit of Each 8-Week Treatment Period in Part 2 and 6-Month Extension Phase of Part 3 [ Time Frame: Part 2: Baseline, Week 8, 19, and 27; Part 3: Baseline up to every month (approximately 6 months) ]
    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) will be assessed.

  9. Change From Baseline in Calcium Levels at the Last Visit of Each 8-Week Treatment Period in Part 2 and 6-Month Extension Phase of Part 3 [ Time Frame: Part 2: Baseline, Week 8, 19, and 27; Part 3: Baseline up to every month (approximately 6 months) ]
    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) will be assessed.

  10. Change From Baseline in Calcium-Phosphorus Product Levels at the Last Visit of Each 8-Week Treatment Period in Part 2 and 6-Month Extension Phase of Part 3 [ Time Frame: Part 2: Baseline, Week 8, 19, and 27; Part 3: Baseline up to every month (approximately 6 months) ]
    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) will be assessed.

  11. Change From Baseline in Biochemical Bone Markers [ Time Frame: Part 2: Baseline, Week 8, 11, 19 and 27; Part 3: 6 months ]
    Change from baseline in bone turnover markers including bone alkaline phosphatase (ALP), osteocalcin, tartrate-resistant acid phosphatase (TRAP), fibroblast growth factor 23 (FGF-23), parathyroid hormone (PTH), sclerostin and fetuin-A will be assessed.

  12. Change From Baseline in Height [ Time Frame: Parts 2a and 3: Baseline, Week 8, 19 and 40; Parts 2b and 3: Baseline, Week 8 and 32 ]
    Change from baseline in height will be assessed.

  13. Change From Baseline in Weight [ Time Frame: Parts 2a and 3: Baseline, Week 8, 19 and 40; Parts 2b and 3: Baseline, Week 8 and 32 ]
    Change from baseline in weight will be assessed.



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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01696279


Locations
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Argentina
Centro Infantil Del Rinon S.R.L
San Miguel de Tucuman, Tucuman, Argentina, 4000
Chile
Hospital Luis Calvo Mackenna
Santiago, Chile, 7500539
Hospital Dr. Sotero del Rio
Santiago, Chile, 8207257
Czechia
Fakultni nemocnice Ostrava
Ostrava, Czechia, 70852
University Hospital Motol
Prague 5, Czechia, 15006
Germany
Kinder-und Jugendklinik Erlangen
Erlangen, Germany, 91054
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Hungary
Semmelweis Egyetem Altalanos Orvostudomanyi Kar
Budapest, Bokay Janos, Hungary, 1083
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
Debrecen, Hungary, 4032
Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar
Szeged, Hungary, 6720
Poland
Uniwersytecki Dzieciecy Szpital Kliniczny
Bialystok, Poland, 15-274
Uniwersytecki Szpital Dzieciecy w Krakowie, Klinika Nefrologii Dzieciecej ze Stacja Dializ
Krakow, Poland, 30663
NZOZ tri-Medica
Lodz, Poland, 93-338
Uniwersytecki Szpital Kliniczny
Wroclaw, Poland, 50556
Romania
Spitalul Clinic de Urgenta pentru Copii Sf. Maria
Iasi, Romania
Spitalul Clinic de Urgenta pentru Copii - Louis Turcanu
Timisoara, Romania, 300350
Russian Federation
Children City Clinical Hospital of Saint Vladimir
Moscow, Russian Federation, 107014
Saint-Petersburg State Budgetary Healthcare Institution "Children City Hospital #1"
Saint-Petersburg, Russian Federation, 198205
State Budgetary Healthcare Instit. of Sverdiov Region "Regional Children Clinical Hosp #1"
Yekaterinburg, Russian Federation, 620143
Turkey
Cukurova University Faculty of Medicine Paediatric Nephrology
Adana, Turkey, 01330
Izmir Tepecik Training and Research Hospital
Izmir, Turkey, 4500
Manisa Celal Bayar University Hafsa Sultan Hospital
Manisa, Turkey, 45030
Sponsors and Collaborators
Shire
Investigators
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Study Director: Study Director Shire

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Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01696279     History of Changes
Other Study ID Numbers: SPD405-207
2012-000171-17 ( EudraCT Number )
First Posted: October 1, 2012    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Hyperphosphatemia
Urologic Diseases
Renal Insufficiency
Phosphorus Metabolism Disorders
Metabolic Diseases
Calcium
Calcium, Dietary
Calcium Carbonate
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents