Chewed vs. Crushed Lanthanum Carbonate in Hemodialysis Patients

This study has been completed.
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
Alan Lau, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT00660530
First received: April 9, 2008
Last updated: December 16, 2013
Last verified: December 2013
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Evaluation of Chewed vs. Crushed Lanthanum Carbonate in the Efficacy of Phosphate Binding in Hemodialysis Patients

Resource links provided by NLM:


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

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

Enrollment: 14
Study Start Date: January 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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
Experimental: 2
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
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: NCT00660530

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

No publications provided

Responsible Party: Alan Lau, Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT00660530     History of Changes
Other Study ID Numbers: 2006-0588
Study First Received: April 9, 2008
Last Updated: December 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Illinois at Chicago:
stage 5
chronic
hemodialysis

Additional relevant MeSH terms:
Kidney Diseases
Hyperphosphatemia
Urologic Diseases
Phosphorus Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 15, 2014