Cross-Over Study of Sevelamer Hydrochloride and Sevelamer Carbonate - Full Text View

Purpose

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

Condition	Intervention	Phase
Chronic Kidney Disease	Drug: sevelamer carbonate, sevelamer hydrochloride Drug: sevelamer hydrochloride, sevelamer carbonate	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Double-Blind, Cross-Over Design Study of Sevelamer Hydrochloride (Renagel®) and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis

Resource links provided by NLM:

MedlinePlus related topics: Chronic Kidney Disease

Drug Information available for: Sevelamer Sevelamer hydrochloride Sevelamer carbonate

U.S. FDA Resources

Further study details as provided by Genzyme:

Primary Outcome Measures:

Safety-evaluated on the basis of adverse events (reported and/or observed) [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
changes in laboratory parameters, vital signs [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
note: clinically significant changes in physical examination were recorded and evaluated as adverse events [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Enrollment:	80
Study Start Date:	March 2005
Study Completion Date:	July 2006
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 sevelamer carbonate w(1-8) sevelamer hydrochloride w(9-16)	Drug: sevelamer carbonate, sevelamer hydrochloride Starting dose individualized for each patient and fixed daily dose throughout both treatment periods
2 sevelamer hydrochloride w(1-8) sevelamer carbonate w(9-16)	Drug: sevelamer hydrochloride, sevelamer carbonate Starting dose individualized for each patient and fixed daily dose throughout both treatment periods

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440648

Locations

United States, Alabama

Mobile, Alabama, United States, 36608
United States, California

Riverside, California, United States, 92501
United States, Colorado

Greenwood Village, Colorado, United States, 80111
United States, Illinois

Berwyn, Illinois, United States, 60402

Crestwood, Illinois, United States, 60445
United States, Indiana

Indianapolis, Indiana, United States, 46202

Valparaiso, Indiana, United States, 46383
United States, Missouri

Columbus, Missouri, United States, 39705

St. Louis, Missouri, United States, 63110

St. Louis, Missouri, United States, 63103
United States, North Carolina

Winston-Salem, North Carolina, United States, 27157
United States, Pennsylvania

Easton, Pennsylvania, United States, 19045

Wynnewood, Pennsylvania, United States, 19096
United States, Tennessee

Nashville, Tennessee, United States, 37205
United States, Virginia

Norfolk, Virginia, United States, 23507

Sponsors and Collaborators

Genzyme

Investigators

Study Director:

Medical Monitor

Genzyme

More Information

No publications provided

Responsible Party:	Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier:	NCT00440648 History of Changes
Other Study ID Numbers:	GD3-163-201
Study First Received:	February 24, 2007
Last Updated:	July 29, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency

Sevelamer
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013