A Comparison of Lanthanum Carbonate and Calcium Carbonate in Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Shire
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01696279
First received: September 26, 2012
Last updated: June 6, 2014
Last verified: April 2014
  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 8 Months of Treatment With Lanthanum Carbonate in Hyperphosphataemic Children and Adolescents Aged 10 Years to <18 Years With Chronic Kidney Disease on Dialysis

Resource links provided by NLM:


Further study details as provided by Shire:

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 10 Months [ Time Frame: Baseline and up to 10 months ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Calcium Levels at up to 10 Months [ Time Frame: Baseline and up to 10 months ] [ Designated as safety issue: Yes ]
  • Change from baseline in Calcium-Phosphorous Product at up to 10 Months [ Time Frame: Baseline and up to 10 months ] [ Designated as safety issue: Yes ]
  • Change from baseline in Bone Alkaline Phosphatase (ALP) at Up to 10 Months [ Time Frame: Baseline and up to 10 months ] [ Designated as safety issue: No ]
  • Change from Baseline in Tartrate-Resistant Acid Phosphatase (TRAP) at Up to 10 Months [ Time Frame: Baseline and up to 10 months ] [ Designated as safety issue: No ]
  • Change from Baseline Osteocalcin levels at Up to 10 [ Time Frame: Baseline and up to 10 months ] [ Designated as safety issue: No ]
  • Change from Baseline in Fibroblast Growth factor 23 (FGF-23) Levels at Up to 10 Months [ Time Frame: Baseline and up to 10 months ] [ Designated as safety issue: No ]
  • Change from Baseline in Parathyroid Hormone (PTH) Levels at Up to 10 Months [ Time Frame: Baseline and up to 10 months ] [ Designated as safety issue: No ]
  • Change from Baseline in Sclerostin Levels at Up to 10 Months [ Time Frame: Baseline and up to 10 months ] [ Designated as safety issue: No ]
  • Change from Baseline in Fetuin-A Levels at Up to 10 Months [ Time Frame: Baseline and up to 10 months ] [ Designated as safety issue: No ]
  • Change from Baseline in Height at up to 10 Months [ Time Frame: Baseline and up to 10 months ] [ Designated as safety issue: No ]
  • Change from Baseline in Weight at Up to 10 Months [ Time Frame: Baseline and up to 10 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: February 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 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 1500 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 taken by the subject prior to starting the study or equivalent. For new subjects, dosing will be 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 6500mg is reached.

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged 10 years 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Recruiting
San Miguel de Tucuman, Tucuman, Argentina, 4000
Contact: Paula Rodriguez    0381156449317    paula_rod@hotmail.com   
Principal Investigator: Susana C Miceli, Dr         
Hospital de Ninos Ricardo Gutierrez Not yet recruiting
Buenos Aires, Argentina, C1425EFD
Contact: Miguel Liern    00541541461822      
Principal Investigator: Graciela Vallejo, Dr         
Bulgaria
Specialized Hospital For Active Treatment In Pediatrics-Sofia Nephrology And Haemodialysis Clinic Active, not recruiting
Sofia, Bulgaria, 1606
Chile
Hospital Luis Calvo Mackenna Recruiting
Santiago, Chile, 7500539
Contact: Maria Jose Ibacache       mjibacache@hotmail.com   
Principal Investigator: Francisco Cano, MD         
Hospital Dr. Sotero del Rio Recruiting
Santiago, Chile, 8207257
Contact: Antonella Sandretti    +562 2576 2617    asandretti@ssmso.cl   
Principal Investigator: Claudia Gonzalez, MD         
Czech Republic
Fakultni nemocnice Ostrava Active, not recruiting
Ostrava, Czech Republic, 70852
University Hospital Motol Active, not recruiting
Prague 5, Czech Republic, 15006
Germany
Kinder-und Jugendklinik Erlangen Recruiting
Erlangen, Germany, 91054
Contact: Antje Neubert    004991318541237    Antje.neubert@uk-erlangen.de   
Principal Investigator: Wolfgang Rascher, Prof         
Medizinische Hochschule Hannover Recruiting
Hannover, Germany, 30625
Contact: Nicole Meyer    00495115327848    meyer.nicol@mh-hannover.de   
Sub-Investigator: Dieter Haffner, Prof         
Principal Investigator: Lars Pape, Pr         
Hungary
Semmelweis Egyetem Altalanos Orvostudomanyi Kar Recruiting
Budapest, Bokay Janos, Hungary, 1083
Contact: Judit Horvath Turmezeine    003613343186 ext 52633    tuju@gyer1.sote.hu   
Principal Investigator: Peter Sallay, Dr         
De OEC Gyermekgyogyaszati Intezet Recruiting
Debrecen, Hungary, 4032
Contact: Inrene Banyasz       tundebanyasz@gmail.com   
Principal Investigator: Tamas Sazbo, Dr         
Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Recruiting
Szeged, Hungary, 6720
Contact: Csaba Bereczki       bereczki.csaba@med.u-szeged.hu   
Principal Investigator: Sandor Turi, Dr         
Poland
Uniwersytecki Dzieciecy Szpital Kliniczny Recruiting
Bialystok, Poland, 15-274
Contact: Malgorzata Smolko    0048857450823    gosia.smolko@gmail.com   
Principal Investigator: Anna Wasilewska, Prof         
Uniwersyteckie Centrum Kliniczne Recruiting
Gdansk, Poland, 80952
Contact: Irena Blasz-Chmielewska, MD       ibalasz@gumed.edu.pl   
Principal Investigator: Aleksandra Zurowska, MD         
Uniwersytecki Szpital Dzieciecy w Krakowic Recruiting
Krakow, Poland, 30663
Contact: Teresa Smolnik       teresa.smolnik@gmail.com   
Principal Investigator: Katarzyna Zachwieja         
NZOZ tri-Medica Recruiting
Lodz, Poland, 93-338
Contact: Anna Krakowska       annakrakowska@onet.pl   
Principal Investigator: Marcin Tkaczyk, Prof         
Dzieciecy Szpital Kliniczny Im Recruiting
Lublin, Poland, 20-093
Contact: Beata Bienias       beata.bienias@umlub.pl   
Principal Investigator: Malgorzata Zajaczkowska, Prof         
Uniwersytecki Szpital Kliniczny Recruiting
Wroclaw, Poland, 50556
Contact: Irena Makulska       tundebanyasz@gmail.com   
Principal Investigator: Danuta Zwolinska         
Romania
Spitalul Clinic de Urgenta pentru Copii Sf. Maria Active, not recruiting
Iasi, Romania
Spitalul Clinic de Urgenta pentru Copii - Louis Turcanu Active, not recruiting
Timisoara, Romania, 300350
Russian Federation
Children City Clinical Hospital of Saint Vladimir Active, not recruiting
Moscow, Russian Federation, 107014
Saint-Petersburg State Budgetary Healthcare Institution "Children City Hospital #1" Active, not recruiting
Saint-Petersburg, Russian Federation, 198205
State Budgetary Healthcare Instit. of Sverdlov Region "Regional Children Clinical Hosp # 1" Active, not recruiting
Yekaterinburg, Russian Federation, 620143
Turkey
Cukurova University Faculty of Medicine Paediatric Nephrology Active, not recruiting
Adana, Turkey, 01330
Izmir Tepecik Training and Research Hospital Active, not recruiting
Izmir, Turkey, 4500
Inonu University Faculty of Medicine Department of Pediatric Health and Disease Active, not recruiting
Malatya, Turkey, 44280
Manisa Celal Bayar University Hafsa Sultan Hospital Active, not recruiting
Manisa, Turkey, 45030
Sponsors and Collaborators
Shire
Investigators
Principal Investigator: Dieter Haffner, Prof Hannover Medical School
  More Information

No publications provided

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01696279     History of Changes
Other Study ID Numbers: SPD405-207, 2012-000171-17
Study First Received: September 26, 2012
Last Updated: June 6, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Chile: Instituto de Salud Pública de Chile
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Turkey: Ministry of Health
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
Bulgaria: Bulgarian Drug Agency
Romania: Comisia Nationala de Bioetica a Medicamentului si Dispozitivelor Medicale
Czech Republic: Statni ustav pro kontrolu leciv

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

ClinicalTrials.gov processed this record on July 29, 2014