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Completed

NCT Number: NCT00440648

Cross-Over Study of Sevelamer Hydrochloride and Sevelamer Carbonate

This is a double-blind, randomized, cross-over study conducted at centers within the United States. The study consists of five periods: an up to two-week Screening Period, a 5-week Run-In Period, two eight-week study treatment periods and a two-week Washout Period. Patients are assigned randomly (1:1) to one of two treatment sequences: sevelamer carbonate for eight weeks followed by sevelamer hydrochloride for eight weeks or sevelamer hydrochloride for eight weeks followed by sevelamer carbonate for eight weeks

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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

Mobile, Alabama, United States

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About this study

The study was conducted at 15 centers (2 of which did not enroll any patients). A total of 79 hemodialysis patients were assigned randomly to one of two treatment sequences.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patient had received hemodialysis three times per week for 3 months or longer;
  • patients were maintained on sevelamer hydrochloride as their primary phosphate binder with a total daily dose of ≤ 13.6 g with serum phosphorus concentrations at the last two measurements between 3.0 and 6.5 mg/dL, the most recent iPTH ≤ 600 pg/mL and the most recent serum calcium within the normal range.

Exclusion criteria

  • if patient had active bowel obstruction, dysphagia, swallowing disorders, or 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; or
  • any clinically significant unstable medical condition as judge by the Investigator.

Treatment and study plan

sevelamer carbonate, sevelamer hydrochloride

Drug

Starting dose individualized for each patient and fixed daily dose throughout both treatment periods

sevelamer hydrochloride, sevelamer carbonate

Drug

Starting dose individualized for each patient and fixed daily dose throughout both treatment periods

Primary outcomes

  1. Safety-evaluated on the basis of adverse events (reported and/or observed)

    Time frame: 16 weeks

  2. changes in laboratory parameters, vital signs

    Time frame: 16 weeks

  3. note: clinically significant changes in physical examination were recorded and evaluated as adverse events

    Time frame: 16 weeks

  4. Efficacy-treatment regimens are compared on the basis of serum phosphorus at the end of each treatment period using the time-weighted mean of the phosphorus value from the last three visits in each treatment period

    Time frame: 16 weeks

  5. Treatment regimens were also compared with respect to total, LDL, and HDL cholesterol, and triglycerides, using the mean of values for each parameter from the two post-baseline assessments in each treatment period.

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Registry information

Official study title

A Double-Blind, Cross-Over Design Study of Sevelamer Hydrochloride (Renagel®) and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Feb 27, 2007
Registry last updated
Mar 19, 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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