Head to Head Study Against Sevelamer Hydrochloride

Overview

To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.

Full Title of Study: “A Prospective, Multicenter, Open-label, Randomized, Cross-over Study to Compare the Efficacy and Safety of Fosrenol® and Sevelamer Hydrochloride in Patients Receiving Hemodialysis for End Stage Renal Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 31, 2008

Detailed Description

To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.

Interventions

  • Drug: Fosrenol (Lanthanum Carbonate)
    • The starting dose is a total daily dose of 2250mg of Fosrenol (Lanthanum carbonate) to a maximum dose of 3000mg daily. Chewable tablets will be administered orally with meals in 750mg and 1000mg strength tablets.
  • Drug: Sevelamer hydrochloride
    • The starting dose is a total daily dose of 4800mg of sevelamer hydrochloride up to a maximum of 6400 mg daily. Sevelamer hydrochloride 800mg tablets, administered orally with meals.

Arms, Groups and Cohorts

  • Experimental: 1
    • Fosrenol (Lanthanum carbonate)
  • Active Comparator: 2
    • Sevelamer hydrochloride

Clinical Trial Outcome Measures

Primary Measures

  • Change From Baseline in Serum Phosphorus Levels at 4 Weeks
    • Time Frame: 4 weeks

Secondary Measures

  • Change From Baseline in Serum Calcium Levels at 4 Weeks
    • Time Frame: 4 weeks
  • Levels of Intact Parathyroid Hormone (iPTH) at Baseline and 4 Weeks
    • Time Frame: Baseline and 4 weeks
  • Patients Achieving Kidney Disease Outcomes Quality Initiative (KDOQI) Target for Serum Phosphorous at 4 Weeks
    • Time Frame: 4 weeks
    • Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous is 3.5 – 5.5 mg/dL (1.13 – 1.77 mmol/L)

Participating in This Clinical Trial

Inclusion Criteria

  • Adults with end stage renal disease who are receiving dialysis Exclusion Criteria:

  • Subjects with significant gastrointestinal disorders – Subjects who are pregnant or nursing – Subjects currently taking lanthanum carbonate, sevelamer hydrochloride, cinacalcet hydrochloride – Subjects who are HIV positive – Subjects with clinical significant liver disease

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shire
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Study Director, Study Director, Takeda

References

Sprague SM, Ross EA, Nath SD, Zhang P, Pratt RD, Krause R. Lanthanum carbonate vs. sevelamer hydrochloride for the reduction of serum phosphorus in hemodialysis patients: a crossover study. Clin Nephrol. 2009 Oct;72(4):252-8. doi: 10.5414/cnp72252.

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