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Completed

NCT Number: NCT01755078

Long Term Evaluation of Sevelamer HCl vs. Calcium-based Phosphate Binder in the Treatment of Hyperphosphatemia in Hemodialysis Patients

The study is designed to compare sevelamer vs. calcium-based phosphate binder in hemodialysis patients to achieve full-scale of medical care, including reduction of atherosclerotic risk factors, reduction of vascular access reconstruction rate, and pharmacoeconomic analysis.

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Key information

Conditions

Hemodialysis Cardiovascular Events Hyperphosphatemia Metabolic Diseases Nutritional and Metabolic Diseases Phosphorus Metabolism Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Males or females aged between 18-70 years old
  • Subject with hyperphosphatemia (5.5 - 8.5 mg/dL) at both WK(-2) and WK0
  • On stable TIW hemodialysis for 3 months or longer

Exclusion criteria

  • Patients with hypercalcemia (corrected serum calcium > 10.5 mg/dL)
  • Any of the following abnormalities: ALT or AST > 3X ULN; iPTH > 1000 or < 150 pg/mL
  • History of dysphagia or swallowing disorders
  • History of GI motility disorder or GI bleeding within 3 months prior to entry

Treatment and study plan

Sevelamer HCl

Drug

Non-metal phosphate binder

Other names: Renagel Tablets

Calcium-based phosphate binder

Drug

Other names: Calcium carbonate, Calcium acetate

Primary outcomes

  1. Composite end-point of Ca, P, Ca*P within K/DOQI recommendation

    Time frame: 12 months

Secondary outcomes

  1. Change from baseline, Ca, P, Ca*P

    Time frame: 12 months

  2. Change from baseline, lipid profile

    Time frame: 12 months

  3. Change from baseline, CRP

    Time frame: 12 months

  4. Change from baseline, iPTH (stragified)

    Time frame: 12 months

  5. Change from baseline, homocysteine, folate and Vit B12

    Time frame: 12 months

  6. CV-related event rate (OPD admission and hospitalization)

    Time frame: 12 months

  7. Comparison of medical-related expenses between group

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Chugai Pharma Taiwan

Industry

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Dec 21, 2012
Registry last updated
Aug 5, 2014

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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