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Study to Compare Sevelamer Carbonate Powder to Sevelamer Hydrochloride Tablets in Patients With CKD on Hemodialysis

Primary Purpose

Kidney Diseases, Chronic Renal Insufficiency, End-Stage Renal Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Sevelamer carbonate (Renvela®)
Sevelamer hydrochloride (Renagel®)
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Diseases focused on measuring Chronic, Hemodialysis, Kidney, Hyperphosphatemia, Chronic kidney disease, Chronic Renal Insufficiency

Eligibility Criteria

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

Inclusion Criteria: On three times per week hemodialysis for three months or longer Currently on a phosphate binder(s) Considered compliant with phosphate binders and hemodialysis therapy Willing to avoid any intentional changes in diet such as fasting or dieting Have the following documented local laboratory measurements:a.Two most recent consecutive serum phosphorus measurements that are ≥ 3.0 and ≤ 6.5 (6.5) mg/dL within 60 days of screening; b.A most recent intact parathyroid hormone (iPTH) measurement ≤ 800 pg/mL within 90 days of screening Have the following central laboratory measurements: a.A serum phosphorus measurement > 5.5 mg/dL at randomization (Week 0);b.A serum iPTH measurement ≤ 800 pg/mL at screening Have not participated in any other investigational drug studies within 30 days prior to enrollment Level of understanding and willingness to cooperate with all visits and procedures as described by the study personnel Willing and able to take sevelamer alone as a phosphate binder for the duration of the study Willing and able to maintain screening doses of lipid medication for the duration of the study, except for safety reasons Willing and able to avoid antacids and phosphate binders containing aluminum, magnesium, calcium or lanthanum for the duration of the study unless prescribed as an evening calcium supplement If female and of childbearing potential (pre-menopausal and not surgically sterile), willing to use an effective contraceptive method throughout the study, which includes barrier methods, hormones, or intrauterine devices (IUDs) Life expectancy of 12 months or greater Willing and able to provide informed consent Exclusion Criteria: Active bowel obstruction, dysphagia, swallowing disorder, or severe gastrointestinal (GI) motility disorders Active ethanol or drug abuse, excluding tobacco use In the opinion of the Investigator, subject has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any clinically significant unstable medical condition Use of anti-arrhythmic or anti-seizure medications for the use of arrhythmia or seizure disorders Known hypersensitivity to sevelamer or any constituents of the study drug Pregnant or breast-feeding Evidence of active malignancy except for basal cell carcinoma of the skin Unable to comply with the requirements of the study Any other condition which, in the opinion of the Investigator, will prohibit the subject's inclusion in the study

Sites / Locations

  • Clinical Research Center
  • Gadsden Dialysis
  • Holy Cross Renal Care
  • Nephrology Educational Services and Research
  • Crystal Rivers Dialysis Center
  • Outcomes Research International, Inc.
  • Central Dialysis Center
  • Atlanta Nephrology Referral Center
  • FMC Marietta
  • Horizon Healthcare Associates
  • Indiana University Hospital
  • Ochsner Clinic Foundation, Nephrology Research
  • Henry Ford Hospital
  • Southwest Mississippi Nephrology, PLLC
  • Nephrology Associates, P.C.
  • Nephrology & Hypertension Associates, LTD
  • Washington University School of Medicine
  • Hypertension and Nephrology Associates
  • Davita
  • Winthrop University Dialysis Center
  • Kidney and Hypertension Center
  • Renal Care Group
  • Lewiston Dialysis Center
  • Medical Nephrology Associates
  • Nephrology Associates, P.C.
  • Renal Research Inc. at the Kidney Institute
  • Gambro Healthcare - Charlottesville
  • Clinical Research of Tidewater
  • Virginia Commonwealth University, Division of Nephrology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

sevelamer carbonate powder

Sevelamer hydrochloride

Outcomes

Primary Outcome Measures

Demonstrate the efficacy of sevelamer carbonate powder dosed QD with the largest meal to sevelamer hydrochloride tablets dosed TID with meals on the control of serum phosphorus
Evaluate the safety and tolerability of sevelamer carbonate powder dosed QD with the largest meal compared to sevelamer hydrochloride tablets dosed TID with meals

Secondary Outcome Measures

Compare sevelamer carbonate powder dosed QD with the largest meal to sevelamer hydrochloride tablets TID with meals on serum calcium-phosphorus product and serum lipid profile

Full Information

First Posted
December 22, 2005
Last Updated
March 17, 2014
Sponsor
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00268957
Brief Title
Study to Compare Sevelamer Carbonate Powder to Sevelamer Hydrochloride Tablets in Patients With CKD on Hemodialysis
Official Title
A Randomized, Parallel, Open-Label Study to Compare Once Per Day Sevelamer Carbonate Powder Dosing With Three Times Per Day Sevelamer Hydrochloride Tablet Dosing 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
January 2006 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Genzyme, a Sanofi Company

4. Oversight

5. Study Description

Brief Summary
Approximately 207 patients with chronic kidney disease (CKD) on hemodialysis will be entered into this study at approximately 26 centers in the United States. This study aims to evaluate the safety and efficacy of sevelamer carbonate powder dosed once-a-day (QD) with the largest meal compared to sevelamer hydrochloride tablets dosed three-times-per-day (TID) with meals. The total length of participation is approximately 24 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Diseases, Chronic Renal Insufficiency, End-Stage Renal Disease
Keywords
Chronic, Hemodialysis, Kidney, Hyperphosphatemia, Chronic kidney disease, Chronic Renal Insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
217 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
sevelamer carbonate powder
Arm Title
2
Arm Type
Active Comparator
Arm Description
Sevelamer hydrochloride
Intervention Type
Drug
Intervention Name(s)
Sevelamer carbonate (Renvela®)
Intervention Description
sevelamer carbonate powder dosed once per day with largest meal
Intervention Type
Drug
Intervention Name(s)
Sevelamer hydrochloride (Renagel®)
Intervention Description
Sevelamer hydrochloride tablets dosed three times a day with meals
Primary Outcome Measure Information:
Title
Demonstrate the efficacy of sevelamer carbonate powder dosed QD with the largest meal to sevelamer hydrochloride tablets dosed TID with meals on the control of serum phosphorus
Time Frame
Up to 24 weeks
Title
Evaluate the safety and tolerability of sevelamer carbonate powder dosed QD with the largest meal compared to sevelamer hydrochloride tablets dosed TID with meals
Time Frame
Up to 24 weeks
Secondary Outcome Measure Information:
Title
Compare sevelamer carbonate powder dosed QD with the largest meal to sevelamer hydrochloride tablets TID with meals on serum calcium-phosphorus product and serum lipid profile
Time Frame
Up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: On three times per week hemodialysis for three months or longer Currently on a phosphate binder(s) Considered compliant with phosphate binders and hemodialysis therapy Willing to avoid any intentional changes in diet such as fasting or dieting Have the following documented local laboratory measurements:a.Two most recent consecutive serum phosphorus measurements that are ≥ 3.0 and ≤ 6.5 (6.5) mg/dL within 60 days of screening; b.A most recent intact parathyroid hormone (iPTH) measurement ≤ 800 pg/mL within 90 days of screening Have the following central laboratory measurements: a.A serum phosphorus measurement > 5.5 mg/dL at randomization (Week 0);b.A serum iPTH measurement ≤ 800 pg/mL at screening Have not participated in any other investigational drug studies within 30 days prior to enrollment Level of understanding and willingness to cooperate with all visits and procedures as described by the study personnel Willing and able to take sevelamer alone as a phosphate binder for the duration of the study Willing and able to maintain screening doses of lipid medication for the duration of the study, except for safety reasons Willing and able to avoid antacids and phosphate binders containing aluminum, magnesium, calcium or lanthanum for the duration of the study unless prescribed as an evening calcium supplement If female and of childbearing potential (pre-menopausal and not surgically sterile), willing to use an effective contraceptive method throughout the study, which includes barrier methods, hormones, or intrauterine devices (IUDs) Life expectancy of 12 months or greater Willing and able to provide informed consent Exclusion Criteria: Active bowel obstruction, dysphagia, swallowing disorder, or severe gastrointestinal (GI) motility disorders Active ethanol or drug abuse, excluding tobacco use In the opinion of the Investigator, subject has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any clinically significant unstable medical condition Use of anti-arrhythmic or anti-seizure medications for the use of arrhythmia or seizure disorders Known hypersensitivity to sevelamer or any constituents of the study drug Pregnant or breast-feeding Evidence of active malignancy except for basal cell carcinoma of the skin Unable to comply with the requirements of the study Any other condition which, in the opinion of the Investigator, will prohibit the subject's inclusion in the study
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:
Facility Name
Clinical Research Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35213
Country
United States
Facility Name
Gadsden Dialysis
City
Gadsden
State/Province
Alabama
ZIP/Postal Code
35901
Country
United States
Facility Name
Holy Cross Renal Care
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Nephrology Educational Services and Research
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Facility Name
Crystal Rivers Dialysis Center
City
Crystal River
State/Province
Florida
ZIP/Postal Code
34429
Country
United States
Facility Name
Outcomes Research International, Inc.
City
Hudson
State/Province
Florida
ZIP/Postal Code
34667
Country
United States
Facility Name
Central Dialysis Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Atlanta Nephrology Referral Center
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
FMC Marietta
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30066
Country
United States
Facility Name
Horizon Healthcare Associates
City
Flossmoor
State/Province
Illinois
ZIP/Postal Code
60422
Country
United States
Facility Name
Indiana University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Ochsner Clinic Foundation, Nephrology Research
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Southwest Mississippi Nephrology, PLLC
City
Brookhaven
State/Province
Mississippi
ZIP/Postal Code
39601
Country
United States
Facility Name
Nephrology Associates, P.C.
City
Columbus
State/Province
Mississippi
ZIP/Postal Code
39705
Country
United States
Facility Name
Nephrology & Hypertension Associates, LTD
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Hypertension and Nephrology Associates
City
Eatontown
State/Province
New Jersey
ZIP/Postal Code
07724
Country
United States
Facility Name
Davita
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Winthrop University Dialysis Center
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Kidney and Hypertension Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
Renal Care Group
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Lewiston Dialysis Center
City
Lewistown
State/Province
Pennsylvania
ZIP/Postal Code
17044
Country
United States
Facility Name
Medical Nephrology Associates
City
Dyersburg
State/Province
Tennessee
ZIP/Postal Code
38024
Country
United States
Facility Name
Nephrology Associates, P.C.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Renal Research Inc. at the Kidney Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Gambro Healthcare - Charlottesville
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States
Facility Name
Clinical Research of Tidewater
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Virginia Commonwealth University, Division of Nephrology
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study to Compare Sevelamer Carbonate Powder to Sevelamer Hydrochloride Tablets in Patients With CKD on Hemodialysis

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