Head to Head Study Against Sevelamer Hydrochloride

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: February 27, 2007
Last updated: June 6, 2014
Last verified: August 2011
To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.

Condition Intervention Phase
Chronic Kidney Disease, Stage 5
Drug: Fosrenol (Lanthanum Carbonate)
Drug: Sevelamer hydrochloride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Shire:

Primary Outcome Measures:
  • Change From Baseline in Serum Phosphorus Levels at 4 Weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change From Baseline in Serum Calcium Levels at 4 Weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Levels of Intact Parathyroid Hormone (iPTH) at Baseline and 4 Weeks [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
  • Patients Achieving Kidney Disease Outcomes Quality Initiative (KDOQI) Target for Serum Phosphorous at 4 Weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous is 3.5 - 5.5 mg/dL (1.13 - 1.77 mmol/L)

Enrollment: 182
Study Start Date: February 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Fosrenol (Lanthanum carbonate)
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.
Other Name: FOSRENOL
Active Comparator: 2
Sevelamer hydrochloride
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00441545

  Show 44 Study Locations
Sponsors and Collaborators
Principal Investigator: Stuart Sprague, D.O. Evanston Northwestern Hospital
  More Information

Additional Information:
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00441545     History of Changes
Other Study ID Numbers: SPD405-319  2006-004959-38 
Study First Received: February 27, 2007
Results First Received: June 29, 2009
Last Updated: June 6, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Sequestering Agents

ClinicalTrials.gov processed this record on May 03, 2016