A Comparison of Lanthanum Carbonate and Calcium Carbonate in Children
This study is currently recruiting participants.
Verified May 2013 by Shire Development LLC
Sponsor:
Shire Development LLC
Information provided by (Responsible Party):
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT01696279
First received: September 26, 2012
Last updated: May 30, 2013
Last verified: May 2013
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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:
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:
- Aged 6 months to less than 18 years of age at the time of consent
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:
- Unable to eat semi-solid foods or on Total Enteral Alimentation
- Serum PTH greater than 700 pg/mL
- 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 | |
| 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 | |
| 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: Aniko Pongracz 003652255289 pongracz.aniko@med.unideb.hu | |
| 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 | |
| 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 | |
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: | May 30, 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 June 17, 2013