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Cross-Over Study of Sevelamer Hydrochloride and Sevelamer Carbonate

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
sevelamer carbonate, sevelamer hydrochloride
sevelamer hydrochloride, sevelamer carbonate
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

1

2

Arm Description

sevelamer carbonate w(1-8) sevelamer hydrochloride w(9-16)

sevelamer hydrochloride w(1-8) sevelamer carbonate w(9-16)

Outcomes

Primary Outcome Measures

Safety-evaluated on the basis of adverse events (reported and/or observed)
changes in laboratory parameters, vital signs
note: clinically significant changes in physical examination were recorded and evaluated as adverse events
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
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.

Secondary Outcome Measures

Full Information

First Posted
February 24, 2007
Last Updated
March 17, 2014
Sponsor
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00440648
Brief Title
Cross-Over Study of Sevelamer Hydrochloride and Sevelamer Carbonate
Official Title
A Double-Blind, Cross-Over Design Study of Sevelamer Hydrochloride (Renagel®) and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Genzyme, a Sanofi Company

4. Oversight

5. Study Description

Brief Summary
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
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
sevelamer carbonate w(1-8) sevelamer hydrochloride w(9-16)
Arm Title
2
Arm Type
Other
Arm Description
sevelamer hydrochloride w(1-8) sevelamer carbonate w(9-16)
Intervention Type
Drug
Intervention Name(s)
sevelamer carbonate, sevelamer hydrochloride
Intervention Description
Starting dose individualized for each patient and fixed daily dose throughout both treatment periods
Intervention Type
Drug
Intervention Name(s)
sevelamer hydrochloride, sevelamer carbonate
Intervention Description
Starting dose individualized for each patient and fixed daily dose throughout both treatment periods
Primary Outcome Measure Information:
Title
Safety-evaluated on the basis of adverse events (reported and/or observed)
Time Frame
16 weeks
Title
changes in laboratory parameters, vital signs
Time Frame
16 weeks
Title
note: clinically significant changes in physical examination were recorded and evaluated as adverse events
Time Frame
16 weeks
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Genzyme, a Sanofi Company
Official's Role
Study Director
Facility Information:
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
City
Greenwood Village
State/Province
Colorado
ZIP/Postal Code
80111
Country
United States
City
Berwyn
State/Province
Illinois
ZIP/Postal Code
60402
Country
United States
City
Crestwood
State/Province
Illinois
ZIP/Postal Code
60445
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
City
Valparaiso
State/Province
Indiana
ZIP/Postal Code
46383
Country
United States
City
Columbus
State/Province
Missouri
ZIP/Postal Code
39705
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63103
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
City
Easton
State/Province
Pennsylvania
ZIP/Postal Code
19045
Country
United States
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Cross-Over Study of Sevelamer Hydrochloride and Sevelamer Carbonate

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