Chewed vs. Crushed Lanthanum Carbonate in Hemodialysis Patients

NCT00660530 | Completed Phase 2 Results

• 1 other identifier: 2006-0588
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hyperphosphatemia; Kidney Disease

Keywords

stage 5; chronic; hemodialysis

Outcome Measures

Primary Outcomes (1)

• Serum Phosphorous Concentration

  measure of serum P concentration

  Week 1-4 mean

Study Arms (2)

1

ACTIVE COMPARATOR

One week before the administration of crushed or chewed lanthanum, the subjects were instructed to discontinue their P-binding agents, if prescribed previously. At the end of the 1-week washout period, subjects whose serum P exceeded 5.5 mg/dL were randomized to receive, in a crossover fashion, lanthanum 1000 mg (Fosrenol, Shire US Inc., Wayne, PA, USA) 3 times daily to be chewed with meals (chewed LAN) or lanthanum 1000 mg crushed into a fine powder and taken with meals 3 times daily (crushed LAN), for 4 weeks each. The lanthanum tablets were crushed into a fine powder using a mortar and pestle by the investigators, individually wrapped in powder packets and dispensed to the subjects on a weekly basis. The subjects were instructed to empty the powder into a small plastic cup provided, mix with 2 tablespoonfuls of applesauce and take it with meals. After each treatment (chewed or crushed LAN), there was a 1-week washout period.

Drug: Lanthanum Carbonate Chewable Product

2

EXPERIMENTAL

After the one-week washout period, the subject received the other lanthanum treatment (chewed or crushed) that they did not receive in the initial treatment period.

Drug: Lanthanum carbonate crushed powder

Interventions

Lanthanum Carbonate Chewable Product DRUG

Lanthanum carbonate 1 g to be chewed, three times daily with meals

Also known as: Fosrenol

1

Lanthanum carbonate crushed powder DRUG

Lanthanum carbonate (Fosrenol) 1 g crushed into a fine powder, three times daily with meal

Also known as: Fosrenol

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

  PMID: 40576086 DERIVED

MeSH Terms

Conditions

Hyperphosphatemia; Kidney Diseases; Bronchiolitis Obliterans Syndrome

Interventions

lanthanum carbonate

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Results Point of Contact

• Title: Dr. Alan Lau
• Organization: University of Illinois College of Pharmacy

alanlau@uic.edu

(312) 996-0894

Study Officials

• Alan H Lau, Pharm.D.

  Univsersity of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• 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 9, 2008
• First Posted: April 17, 2008
• Study Start: January 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: November 3, 2020
• Results First Posted: October 1, 2020

Record last verified: 2020-10

Locations

US (1)