CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 11 enrolled
Drug / intervention
Lanthanum Carbonate Chewable Product +1 moredrug
Likely dose
Lanthanum Carbonate Chewable Product 1 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00660530
NCT00660530Phase 2Completed

An Evaluation of Chewed vs. Crushed Lanthanum Carbonate in the Efficacy of Phosphate Binding in Hemodialysis Patients

University of Illinois at Chicago·interventional·Posted Apr 17, 2008·Updated Nov 3, 2020

In Brief

A Phase 2 clinical trial evaluating Lanthanum Carbonate Chewable Product and Lanthanum carbonate crushed powder for Hyperphosphatemia and Kidney Disease. Completed, enrolled 11 participants across 1 site.

Detailed Summary

Patients with end-stage renal disease (ESRD) commonly develop hyperphosphatemia due to the loss of excretory function of the kidney. This in turn may lead to the development of secondary hyperparathyroidism (SHPT) and renal osteodystrophy. Lanthanum carbonate, a phosphate binding agent, works by releasing lanthanum ions in the gastrointestinal tract to bind dietary phosphate and is effective in the management of hyperphosphatemia and in preventing secondary hyperparathyroidism. Patients taking lanthanum carbonate as part of their phosphate binder therapy are counseled to chew the tablets completely before swallowing, with or immediately after meals. However, ESRD patients who are intubated or are receiving enteral tube feedings are unable to chew the lanthanum carbonate tablets. For such patients, medications are commonly crushed and administered through a gastrostomy tube (G-tube). Some patients may also prefer to crush the lanthanum carbonate tablets and mix it with food instead of chewing. To date, it is not known if crushing the lanthanum carbonate tablets prior to administration and taking it with food will be as efficacious as chewing it. The objective of this study is to compare the efficacy of phosphate binding between chewed and crushed lanthanum carbonate in patients undergoing hemodialysis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsShire

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 17, 2008
Enrollment StartJan 1, 2008
Primary CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 18.2 years ago

Interventions

Lanthanum Carbonate Chewable Productdrug

Lanthanum carbonate 1 g to be chewed, three times daily with meals

Lanthanum carbonate crushed powderdrug

Lanthanum carbonate (Fosrenol) 1 g crushed into a fine powder, three times daily with meal