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

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.

Study Overview

• Status: Completed
• Conditions: Hyperphosphatemia in Chronic Kidney Disease
• Intervention / Treatment: Drug: Lanthanum carbonate (chewed vs. crushed)

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago, Dept of Pharmacy Practice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serum phosphorous concentration	Hourly from time=0-8 h after administration of meal and drug

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: Shire
• Investigators: Principal Investigator: Alan H Lau, Pharm.D., University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: April 6, 2007
• First Submitted That Met QC Criteria: April 6, 2007
• First Posted (Estimate): April 10, 2007

Study Record Updates

• Last Update Posted (Actual): December 20, 2019
• Last Update Submitted That Met QC Criteria: December 18, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Urologic Diseases; Renal Insufficiency; Phosphorus Metabolism Disorders; Kidney Diseases; Renal Insufficiency, Chronic; Hyperphosphatemia
• Other Study ID Numbers: 2006-0530