A Comparison of Lanthanum Carbonate and Calcium Carbonate in Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by Shire
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: September 26, 2012
Last updated: April 6, 2015
Last verified: April 2015

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.


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

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

Contact: Shire Call Centre +1 866 842 5335

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, MD         
Hospital de Ninos Ricardo Gutierrez Active, not recruiting
Buenos Aires, Argentina, C1425EFD
Specialized Hospital For Active Treatment In Pediatrics-Sofia Nephrology And Haemodialysis Clinic Withdrawn
Sofia, Bulgaria, 1606
Hospital Dr. Sotero del Rio Recruiting
Santiago, Chile, 8207257
Contact: Antonella Sandretti    +562 2576 2617    asandretti@ssmso.cl   
Principal Investigator: Claudia Gonzalez, MD         
Hospital Luis Calvo Mackenna Recruiting
Santiago, Chile, 7500539
Contact: Maria Jose Ibacache    +56-2-22356915    mjibacache@hotmail.com   
Principal Investigator: Francisco Cano, MD         
Czech Republic
Fakultni nemocnice Ostrava Recruiting
Ostrava, Czech Republic, 70852
Contact: Eliska Gelnarova    420 597 373 563    tomas.zaoral@fno.cz   
Principal Investigator: Tomas Zaoral, MD         
University Hospital Motol Active, not recruiting
Prague 5, Czech Republic, 15006
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   
Principal Investigator: Lars Pape, MD         
Semmelweis Egyetem Altalanos Orvostudomanyi Kar Recruiting
Budapest, Bokay Janos, Hungary, 1083
Contact: Istvanne Bori    00 361 330374    borikati@freemail.hu   
Principal Investigator: Peter Sallay, MD         
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum Recruiting
Debrecen, Hungary, 4032
Contact: Imrene Banyasz       tundebanyasz@gmail.com   
Principal Investigator: Tamas Sazbo, MD         
Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Withdrawn
Szeged, Hungary, 6720
Uniwersytecki Dzieciecy Szpital Kliniczny Recruiting
Bialystok, Poland, 15-274
Contact: Malgorzata Smolko    48857450823    gosia.smolko@gmail.com   
Principal Investigator: Anna Wasilewska, Prof         
Uniwersyteckie Centrum Kliniczne Withdrawn
Gdansk, Poland, 80952
Uniwersytecki Szpital Dzieciecy w Krakowie, Klinika Nefrologii Dzieciecej ze Stacja Dializ Recruiting
Krakow, Poland, 30663
Contact: Teresa Smolnik       teresa.smolnik@gmail.com   
Principal Investigator: Katarzyna Zachwieja, MD         
NZOZ tri-Medica Recruiting
Lodz, Poland, 93-338
Contact: Marcin Tkaczyk, Prof    +48 42 271 17 60    mtkaczyk@uni.lodz.pl   
Principal Investigator: Marcin Tkaczyk, Prof         
Dzieciecy Szpital Kliniczny im. Prof. A. Gebali,Klinika Pediatrii i Nefrologii z Podstacja Dializ Withdrawn
Lublin, Poland, 20-093
Uniwersytecki Szpital Kliniczny Recruiting
Wroclaw, Poland, 50556
Contact: Danuta Zwolinska    +48 71.736.44.00    danuta.zwolinska@umed.wroc.pl   
Principal Investigator: Danuta Zwolinska, Prof         
Spitalul Clinic de Urgenta pentru Copii Sf. Maria Recruiting
Iasi, Romania
Contact: Elena Marin    0232/264266    mihaelamunteanu2001@gmail.com   
Principal Investigator: Mihaela Munteanu, MD         
Spitalul Clinic de Urgenta pentru Copii - Louis Turcanu Recruiting
Timisoara, Romania, 300350
Contact: Claudia Comlosan    40744820491    laura.stefanescu@iconplc.com   
Principal Investigator: Mihai Gafencu, MD         
Russian Federation
Children City Clinical Hospital of Saint Vladimir Recruiting
Moscow, Russian Federation, 107014
Contact: Alexander Muzurov       muz_al@rambler.ru   
Principal Investigator: Dmitriy Zverev, MD         
Saint-Petersburg State Budgetary Healthcare Institution "Children City Hospital #1" Recruiting
Saint-Petersburg, Russian Federation, 198205
Contact: Aleksey Shavkin, MD    00 7 812 735 4838    dialys.dgb@gmail.com   
Principal Investigator: Aleksey Shavkin, MD         
State Budgetary Healthcare Instit. of Sverdlov Region "Regional Children Clinical Hosp # 1" Withdrawn
Yekaterinburg, Russian Federation, 620143
South Africa
University of KwaZulu Natal Withdrawn
Durban, South Africa, 4001
Cukurova University Faculty of Medicine Paediatric Nephrology Recruiting
Adana, Turkey, 01330
Contact: Safak Oznergiz, Dr.    +90 322 3386935    safakoznergiz@hotmail.com   
Principal Investigator: Aysun Karabay Bayazit, MD         
Izmir Tepecik Training and Research Hospital Recruiting
Izmir, Turkey, 4500
Contact: Sevginar Senturk       sevginarsenturk@mynet.com   
Principal Investigator: Nejat Asku, MD         
Inonu University Faculty of Medicine Department of Pediatric Health and Disease Withdrawn
Malatya, Turkey, 44280
Manisa Celal Bayar University Hafsa Sultan Hospital Recruiting
Manisa, Turkey, 45030
Contact: Yildiz Yesil    90 5323710830    yldzysl@hotmail.com   
Principal Investigator: Pelin Ertan, MD         
Sponsors and Collaborators
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: April 6, 2015
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 Carbonate
Calcium, Dietary
Kidney Diseases
Renal Insufficiency, Chronic
Metabolic Diseases
Phosphorus Metabolism Disorders
Renal Insufficiency
Urologic Diseases
Bone Density Conservation Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2015