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

NCT00458289 | Completed Phase 1

• 1 other identifier: 2006-0530
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyperphosphatemia in Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Serum phosphorous concentration

  Hourly from time=0-8 h after administration of meal and drug

Study Arms (3)

1

NO INTERVENTION

P-containing meal alone

2

ACTIVE COMPARATOR

P-containing meal AND single 1 g oral dose of chewed lanthanum carbonate

Drug: Lanthanum carbonate (chewed vs. crushed)

3

ACTIVE COMPARATOR

P-containing meal and single 1 g oral dose of lanthanum carbonate crushed into a fine powder

Drug: Lanthanum carbonate (chewed vs. crushed)

Interventions

Lanthanum carbonate (chewed vs. crushed) DRUG

single 1 g oral dose of lanthanum carbonate either chewed or crushed into a fine powder

2; 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Shire: collaborator

Study Sites (1)

University of Illinois at Chicago, Dept of Pharmacy Practice

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Interventions

lanthanum carbonate

Study Officials

• Alan H Lau, Pharm.D.

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 6, 2007
• First Posted: April 10, 2007
• Study Start: January 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: August 1, 2008
• Last Updated: December 20, 2019

Record last verified: 2019-12

Locations

US (1)