Head to Head Study Against Sevelamer Hydrochloride

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT00441545
First received: February 27, 2007
Last updated: June 6, 2014
Last verified: August 2011
  Purpose

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.

  Eligibility

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

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
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: NCT00441545

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

Additional Information:
Publications:
Lanthanum carbonate vs. sevelamer hydrochloride for the reduction of serum phosphorus in hemodialysis patients: a crossover study. SM Sprague, EA Ross, SD Nath, et al. Clinical Nephrology 2009;72:252-8.

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
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Sevelamer
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014