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Chewed vs. Crushed Lanthanum Carbonate in Hemodialysis Patients
This study is currently recruiting participants.
Verified by University of Illinois, April 2008
Sponsors and Collaborators: University of Illinois
Shire Pharmaceutical Development
Information provided by: University of Illinois
ClinicalTrials.gov Identifier: NCT00660530
  Purpose

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.


Condition Intervention Phase
Hyperphosphatemia
Kidney Disease
Drug: Lanthanum carbonate
Phase II

MedlinePlus related topics: Dialysis Kidney Failure
Drug Information available for: Lanthanum Carbonate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Official Title: An Evaluation of Chewed vs. Crushed Lanthanum Carbonate in the Efficacy of Phosphate Binding in Hemodialysis Patients

Further study details as provided by University of Illinois:

Primary Outcome Measures:
  • serum phosphorous concentration [ Time Frame: Weekly ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2008
Arms Assigned Interventions
1: Active Comparator
Lanthanum 1 g to be chewed, three times daily with meals
Drug: Lanthanum carbonate
Lanthanum carbonate 1 g to be chewed, three times daily with meals
2: Experimental
Lanthanum carbonate 1 g crushed into a fine powder, three times daily with meal
Drug: Lanthanum carbonate
Lanthanum carbonate 1 g crushed into a fine powder, three times daily with meal

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00660530

Contacts
Contact: Priscilla P How, Pharm.D., BCPS 312-413-3720 phow1@uic.edu
Contact: Alan H Lau, Pharm.D. 312-996-0894 alanlau@uic.edu

Locations
United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Priscilla P How, Pharm.D.     312-413-3720     phow1@uic.edu    
Contact: Alan H Lau, Pharm.D.     312-996-0894     alanlau@uic.edu    
Sponsors and Collaborators
University of Illinois
Shire Pharmaceutical Development
Investigators
Principal Investigator: Alan H Lau, Pharm.D. Univsersity of Illinois at Chicago
  More Information

Responsible Party: University of Illinois at Chicago ( Alan Lau, Pharm.D. )
Study ID Numbers: 2006-0588
Study First Received: April 9, 2008
Last Updated: April 10, 2008
ClinicalTrials.gov Identifier: NCT00660530  
Health Authority: United States: Institutional Review Board

Keywords provided by University of Illinois:
stage 5
chronic
hemodialysis

Study placed in the following topic categories:
Metabolic Diseases
Urologic Diseases
Hyperphosphatemia
Kidney Diseases
Metabolic disorder

Additional relevant MeSH terms:
Phosphorus Metabolism Disorders

ClinicalTrials.gov processed this record on January 15, 2009