Efficacy of Phosphate Binding in Healthy Volunteers: Chewed Versus Crushed Lanthanum Carbonate

This study has been completed.
Sponsor:
Collaborator:
Shire
Information provided by:
University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT00458289
First received: April 6, 2007
Last updated: March 11, 2009
Last verified: March 2009
  Purpose

Patients with end-stage renal disease (ESRD) commonly have high concentrations of phosphorous, a mineral, in the blood (hyperphosphatemia). This is a result of their inability to excrete phosphorous by the kidneys. This in turn may result in the development of a condition known as secondary hyperparathyroidism and renal osteodystrophy or bone disease. As such, these patients often receive medications known as phosphate binders such as calcium carbonate or acetate, sevelamer, aluminum hydroxide and lanthanum carbonate to manage and treat hyperphosphatemia.

Lanthanum carbonate is a newly available phosphate binding agent that is effective in the management of hyperphosphatemia and preventing secondary hyperparathyroidism. It works in the gastrointestinal tract by binding to the phosphorus in the diet. ESRD patients taking lanthanum carbonate are counseled to chew the tablets completely before swallowing, with or immediately after meals. However, patients who are intubated or receiving nutrition via feeding tubes are unable to chew the tablets. For these patients, medications are commonly crushed and administered via the tube. Moreover, some patients prefer to crush the 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 would be as effective as chewing them.

The purpose of this study is to compare the efficacy of phosphate binding between chewed and crushed lanthanum carbonate tablets.


Condition Intervention Phase
Hyperphosphatemia in Chronic Kidney Disease
Drug: Lanthanum carbonate (chewed vs. crushed)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • Serum phosphorous concentration [ Time Frame: Hourly from time=0-8 h after administration of meal and drug ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: January 2007
Study Completion Date: August 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
P-containing meal alone
Active Comparator: 2
P-containing meal AND single 1 g oral dose of chewed lanthanum carbonate
Drug: Lanthanum carbonate (chewed vs. crushed)
single 1 g oral dose of lanthanum carbonate either chewed or crushed into a fine powder
Active Comparator: 3
P-containing meal and single 1 g oral dose of lanthanum carbonate crushed into a fine powder
Drug: Lanthanum carbonate (chewed vs. crushed)
single 1 g oral dose of lanthanum carbonate either chewed or crushed into a fine powder

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women at least 18 years of age
  • No clinically significant abnormal findings on clinical laboratory evaluation and medical history
  • Within 15% of ideal body weight for height and build according to the Metropolitan Life tables5
  • Women of child-bearing potential (premenopausal and not surgically sterilized) who have a negative pregnancy test
  • Women who are sexually active must be using effective means of contraception

Exclusion Criteria:

  • History of dysphagia or swallowing disorders
  • Clinically significant illness within 3 months of study enrollment
  • Concomitant use of medication that might interact with lanthanum carbonate
  • Pregnant or intends to become pregnant within 30 days of completing the study
  • Breast feeding
  • Alcohol or controlled substance abuse
  • Use of an investigational agent within 30 days of study entry
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00458289

Locations
United States, Illinois
University of Illinois at Chicago, Dept of Pharmacy Practice
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
Shire
Investigators
Principal Investigator: Alan H Lau, Pharm.D. University of Illinois at Chicago
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00458289     History of Changes
Other Study ID Numbers: 2006-0530
Study First Received: April 6, 2007
Last Updated: March 11, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Kidney Diseases
Hyperphosphatemia
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Phosphorus Metabolism Disorders
Metabolic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on July 20, 2014