Chewed vs. Crushed Lanthanum Carbonate in Hemodialysis Patients



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:10/14/2017
Start Date:January 2008
End Date:November 2009

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

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.


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
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2035 W Taylor St
Chicago, Illinois
(312) 996-4350
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