Chewed vs. Crushed Lanthanum Carbonate in Hemodialysis Patients
Information source: University of Illinois
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hyperphosphatemia; Kidney Disease
Intervention: Lanthanum carbonate (Drug); Lanthanum carbonate (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University of Illinois Official(s) and/or principal investigator(s):
Alan H Lau, Pharm.D., Principal Investigator, Affiliation: Univsersity of Illinois at Chicago
Overall contact:
Priscilla P How, Pharm.D., BCPS, Phone: 312-413-3720, Email: phow1@uic.edu
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.
Clinical Details
Official title: An Evaluation of Chewed vs. Crushed Lanthanum Carbonate in the Efficacy of Phosphate Binding in Hemodialysis Patients
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: serum phosphorous concentration
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Priscilla P How, Pharm.D., BCPS, Phone: 312-413-3720, Email: phow1@uic.edu
University of Illinois at Chicago, Chicago, Illinois 60612, United States; Recruiting
Priscilla P How, Pharm.D., Phone: 312-413-3720, Email: phow1@uic.edu
Alan H Lau, Pharm.D., Phone: 312-996-0894, Email: alanlau@uic.edu
Additional Information
Starting date: January 2008
Last updated: April 10, 2008
|
