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Completed

NCT Number: NCT00324376

Study to Compare Once A Day Sevelamer Dosing With Three Times Per Day Sevelamer Dosing

A randomized, cross-over, open-label study will be conducted to evaluate the equivalency, safety and tolerability of sevelamer once per day dosing, given with the largest meal, compared with standard three times per day dosing, in hemodialysis patients previously using sevelamer. Following a two week Run-In period, a total of 24 patients will be randomized to one of the following treatment sequences:

1. sevelamer dosed once a day with the largest meal followed by standard three times per day dosing with meals 2. sevelamer dosed three times per day with meals followed by once a day dosing with the largest meal. Patients will maintain a fixed daily dose throughout both treatment periods based on the most recently prescribed sevelamer dose prior to screening.

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Key information

Conditions

Chronic Kidney Disease 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 2

Primary location

Renal Care Group, Olympia Fields, Illinois, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • life expectancy of at least 12 months,
  • patients have received hemodialysis three times per week for 3 months or longer,
  • patients maintained on sevelamer in a daily dose of ≤ 9,600 mg as their only phosphate binder with serum phosphorus concentrations at the last two measurements between 3.0 and 6.5 mg/dL (0.97 and 2.10 mmol/L).

Exclusion criteria

  • active bowel obstruction,
  • dysphagia,
  • swallowing disorders,
  • severe gastrointestinal motility disorders,
  • active ethanol or drug abuse (excluding tobacco),
  • need for antidysrhythmic or antiseizure medications used to control these conditions,
  • poorly controlled diabetes mellitus or hypertension,
  • active vasculitis,
  • active malignancy other than basal-cell carcinoma,
  • HIV infection,
  • any clinically significant unstable medical condition as judged by the investigator.

Treatment and study plan

Sevelamer Hydrochloride

Drug

Primary outcomes

  1. Treatment compared on basis of serum phosphorus at end of each treatment and calcium corrected for albumin,calcium-phosphorus product,albumin,iPTH,total,LDL,HDL,non-HDL cholesterol,triglycerides. Safety evaluated on AEs;change in lab values.

Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Registry information

Official study title

A Randomized, Cross-Over Study to Compare Once A Day Sevelamer Dosing With Three Times Per Day Sevelamer Dosing

Important dates

Study start
2003
Study completion
2004
First posted
May 11, 2006
Registry last updated
Mar 5, 2015

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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