Chewed vs. Crushed Lanthanum Carbonate in Hemodialysis Patients
Condition: Hyperphosphatemia; Kidney Disease
MeSH terms: Kidney Diseases; Hyperphosphatemia
Intervention: Lanthanum Carbonate Chewable Product; Lanthanum carbonate crushed powder
Intervention description: Lanthanum carbonate 1 g to be chewed, three times daily with meals; Lanthanum carbonate (Fosrenol) 1 g crushed into a fine powder, three times daily with meal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage 5; chronic; hemodialysis

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.
    

Eligibility 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