drugset / Trial / 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

NCT01696279

Phase 2 Completed 63 enrolled Shire
Non-randomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2013-02-15
Primary completion
2018-11-16
Completion
2018-11-16

Drugs

EvaluationDrugModalityDoseRoute
Comparator Calcium carbonate Other / unclassified 1500 mg Oral
Comparator Calcium carbonate Other / unclassified 6500 mg Oral
Subject Lanthanum Carbonate Other / unclassified 500 mg Oral
Subject Lanthanum Carbonate Other / unclassified 1000 mg Oral
Subject Lanthanum Carbonate Other / unclassified 1500 mg Oral
Subject Lanthanum Carbonate Other / unclassified 3000 mg Oral