NCT01696279

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Kidney Disease
• Hyperphosphatemia

Interventions

Type	Name	Description
DRUG	Lanthanum Carbonate	Lanthanum Carbonate 1500 mg to 3000 mg powder will be administered orally.
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.

Timeline

• Start date: 2013-02-15
• Primary completion: 2018-11-16
• Completion: 2018-11-16
• First posted: 2012-10-01
• Last updated: 2021-06-10
• Results posted: 2020-01-02

Locations

22 sites across 9 countries: Argentina, Chile, Czechia, Germany, Hungary, Poland, Romania, Russia, Turkey (Türkiye)