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A Comparison of Lanthanum Carbonate and Calcium Carbonate in Children

This study is currently recruiting participants.
Verified April 2013 by Shire Development LLC
Sponsor:
Information provided by (Responsible Party):
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT01696279
First received: September 26, 2012
Last updated: April 25, 2013
Last verified: April 2013
History of Changes
  Purpose

To provide information about the safety and efficacy of lanthanum carbonate in children compared to standard treatment.


Condition Intervention Phase
Hyperphosphataemia in Chronic Kidney Disease
 Drug: Lanthanum carbonate
Drug: Calcium carbonate
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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 12 Months of Treatment With Lanthanum Carbonate in Hyperphosphataemic Children and Adolescents Aged 6 Months to <18 Years With Chronic Kidney Disease on Dialysis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shire Development LLC:

Primary Outcome Measures:
  • Percentage of subjects achieving age-specific Kidney Disease Outcomes Quality Initiative (KDOQI) targets for serum phosphorus [ Time Frame: 8 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline in serum phosphorus at up to 8 weeks [ Time Frame: Baseline and up to 8 weeks ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Calcium Levels at up to 8 weeks [ Time Frame: Baseline and up to 8 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in Calcium-Phosphorous Product at up to 8 Weeks [ Time Frame: Baseline and up to 8 weeks ] [ Designated as safety issue: Yes ]
  • Maximum Plasma Concentration (Cmax) of Lanthanum Carbonate [ Time Frame: over 48 hours post-dose on Day 1 ] [ Designated as safety issue: No ]
  • Area Under the Plasma Concentration-Time Curve from time Zero to the Time of the Last Quantifiable Concentration (AUC0-t) of Lanthanum Carbonate [ Time Frame: over 48 hours post-dose on Day 1 ] [ Designated as safety issue: No ]
  • Change from baseline in serum phosphorus at up to 12 Months [ Time Frame: Baseline and up to 12 months ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Calcium Levels at up to 12 Months [ Time Frame: Baseline and up to 12 months ] [ Designated as safety issue: Yes ]
  • Change from baseline in Calcium-Phosphorous Product at up to 12 Months [ Time Frame: Baseline and up to 12 months ] [ Designated as safety issue: Yes ]
  • Change from baseline in Bone Alkaline Phosphatase (ALP) at Up to 12 Months [ Time Frame: Baseline and up to 12 months ] [ Designated as safety issue: No ]
  • Change from Baseline in Tartrate-Resistant Acid Phosphatase (TRAP) at Up to 12 Months [ Time Frame: Baseline and up to 12 months ] [ Designated as safety issue: No ]
  • Change from Baseline Osteocalcin levels at Up to 12 [ Time Frame: Baseline and up to 12 months ] [ Designated as safety issue: No ]
  • Change from Baseline in Fibroblast Growth factor 23 (FGF-23) Levels at Up to 12 Months [ Time Frame: Baseline and up to 12 months ] [ Designated as safety issue: No ]
  • Change from Baseline in Parathyroid Hormone (PTH) Levels at Up to 12 Months [ Time Frame: Baseline and up to 12 months ] [ Designated as safety issue: No ]
  • Change from Baseline in Sclerostin Levels at Up to 12 Months [ Time Frame: Baseline and up to 12 months ] [ Designated as safety issue: No ]
  • Change from Baseline in Fetuin-A Levels at Up to 12 Months [ Time Frame: Baseline and up to 12 months ] [ Designated as safety issue: No ]
  • Change from Baseline in Height at up to 12 Months [ Time Frame: Baseline and up to 12 months ] [ Designated as safety issue: No ]
  • Change from Baseline in Weight at Up to 12 Months [ Time Frame: Baseline and up to 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lanthanum Carbonate Drug: Lanthanum carbonate
Subjects will receive Lanthanum carbonate orally at a total daily dose of 750 mg to 3000 mg divided equally between three meals.
Other Name: Fosrenol, SPD405
Active Comparator: Calcium Carbonate Drug: Calcium carbonate
Subjects will receive Calcium carbonate orally at a total daily dose of 1500 mg to 6500 mg divided equally between three meals.

  Eligibility

Ages Eligible for Study:   6 Months to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged 6 months to less than 18 years of age at the time of consent

  2. Serum phosphorus levels as follows:

    • Age less than 12 years: Serum phosphorus greater than 6.0 mg/dL (1.94 mmol/L)
    • Age 12 years and older: Serum phosphorus greater than 5.5 mg/dL (1.78 mmol/L)

Exclusion Criteria:

  1. Unable to eat semi-solid foods or on Total Enteral Alimentation
  2. Serum PTH greater than 700 pg/mL
  3. Serum calcium greater than 10.2 mg/dL (2.54 mmol/L)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01696279

Contacts
Contact: Shire Call Centre +1 866 842 5335

Locations
Argentina
Centro Infantil Del Rinon S.R.L Not yet recruiting
San Miguel de Tucuman, Tucuman, Argentina, 4000
Principal Investigator: Susana C Miceli            
Germany
Hannover Medical School Not yet recruiting
Hannover, Germany, 30625
Contact: Dieter Haffner, Prof            
Principal Investigator: Dieter Haffner, Prof            
Hungary
Semmelweis Egyetem Altalanos Orvostudomanyi Kar Recruiting
Budapest, Bckay Janos, Hungary, 1083
Principal Investigator: Peter Sallay, Dr            
Sponsors and Collaborators
Shire Development LLC
Investigators
Principal Investigator: Dieter Haffner, Prof Hannover Medical School
  More Information

No publications provided

Responsible Party: Shire Development LLC
ClinicalTrials.gov Identifier: NCT01696279     History of Changes
Other Study ID Numbers: SPD405-207
Study First Received: September 26, 2012
Last Updated: April 25, 2013
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Chile: Instituto de Salud Publica de Chile
India: Drugs Controller General of India
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Turkey: Ministry of Health
South Africa: Medicines Control Council
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Russia: Ministry of Health of the Russian Federation

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

ClinicalTrials.gov processed this record on May 19, 2013