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

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00324376
• Other study ID #: GTC-68-209
• Status: Completed
• Phase: Phase 2
• First received: May 9, 2006
• Last updated: March 4, 2015
• Start date: March 2003
• Est. completion date: May 2004

Study information

• Verified date: March 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Sevelamer hydrochloride

Locations

Country	Name	City	State
United States	Kidney and Hypertension Center	Cincinnati	Ohio
United States	Renal Care Group	Olympia Fields	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.

External Links

•   Link to citations for peer-reviewed publications for GTC-68-209
•   US FDA Approved Full Prescribing Information for Renagel®