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Completed

NCT Number: NCT00441545

Head to Head Study Against Sevelamer Hydrochloride

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

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Key information

Conditions

Chronic Kidney Disease, Stage 5 Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

KfH Nierenzentrum/Bad/Konig, Bad König, Germany

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fosrenol (Lanthanum Carbonate)

Drug

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 names: FOSRENOL

Sevelamer Hydrochloride

Drug

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.

Primary outcomes

  1. Change From Baseline in Serum Phosphorus Levels at 4 Weeks

    Time frame: 4 weeks

Secondary outcomes

  1. Change From Baseline in Serum Calcium Levels at 4 Weeks

    Time frame: 4 weeks

  2. Levels of Intact Parathyroid Hormone (iPTH) at Baseline and 4 Weeks

    Time frame: Baseline and 4 weeks

  3. 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)

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 1, 2007
Registry last updated
Jun 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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