Chewed vs. Crushed Lanthanum Carbonate in Hemodialysis Patients

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Illinois at Chicago
• Collaborator: Shire

Criteria

Inclusion Criteria:

• Male or female 18 years of age or older

• Have been on hemodialysis for at least 3 months

• Women of child-bearing potential (premenopausal and not surgically sterilized) who have a negative serum pregnancy test

• On a stable dose of phosphate binder for at least 1 month prior to the study

• On a stable dose of active vitamin D (if previously prescribed) for at least 1 month prior to the study

• Serum phosphorus concentrations > 5.5 mg/dL (1.78 mmol/L) at the end of the washout period

Exclusion Criteria:

• Did not previously respond to phosphate binder therapy

• Known non-compliance with oral medications

• Severe hyperparathyroidism defined as intact-PTH (i-PTH) > 500 pg/ml

• Taking any calcium-, magnesium- or aluminum-containing antacids

• Use of an investigational agent within 30 days of study entry