Phase 2 N=11 Randomized Treatment

Chewed vs. Crushed Lanthanum Carbonate in Hemodialysis Patients

Hyperphosphatemia · Kidney Disease

Bottom Line

View on ClinicalTrials.gov: NCT00660530 ↗

Enrolled (actual)

Serious AEs

13.6%

Results posted

Oct 2020

Primary outcome: Primary: Serum Phosphorous Concentration — 2.0; 1.7 mg/dL

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Lanthanum Carbonate Chewable Product (Drug); Lanthanum carbonate crushed powder (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Illinois at Chicago
Primary completion: Nov 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Serum Phosphorous Concentration	2.0; 1.7	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00660530). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.