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Head to Head Study Against Sevelamer Hydrochloride

Primary Purpose

Chronic Kidney Disease, Stage 5

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Fosrenol (Lanthanum Carbonate)
Sevelamer hydrochloride
Sponsored by
Shire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease, Stage 5

Eligibility Criteria

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

Inclusion Criteria:

  • Adults with end stage renal disease who are receiving dialysis

Exclusion Criteria:

  • Subjects with significant gastrointestinal disorders
  • Subjects who are pregnant or nursing
  • Subjects currently taking lanthanum carbonate, sevelamer hydrochloride, cinacalcet hydrochloride
  • Subjects who are HIV positive
  • Subjects with clinical significant liver disease

Sites / Locations

  • DSI Renal Inc.
  • AKDHC Medical Research Services, LLC
  • Southwest Kidney Institute, PLC
  • University of Arizona Health Service Center
  • Clinical Research Connections
  • South Valley Dialysis Center
  • VA Greater Los Angeles Health Care System, West LA
  • Apex Research of Riverside
  • North Valley Nephrology
  • Western Nephrology & Metabolic Bone Disease, PC
  • Shands University of Florida Outpatient Dialysis
  • Discovery Medical Research Group
  • Pines Clinical Research
  • Clinical Research Center of Indian River Medical Center
  • Kidney Care Associates, LLC
  • Renal Physicians of Georgia
  • Evanston Northwestern Hospital
  • Research by Design, LLC
  • Nephrology Inc.
  • Renal Associates of Baton Rouge
  • Creighton University Medical Center
  • Hypertension and Nephrology, Associates
  • Winthrop Dialysis Center
  • SUNY at Stony Brook NY
  • Wake Nephrology Associates
  • Southeastern Nephrology Associates
  • Northwest Renal Clinic
  • Carolina Nephrology, PA
  • VA Tennessee Valley Healthcare System
  • Rosa Verde Tower
  • University of Texas Health Science Center at San Antonio Medicine/Nephrology
  • Alexandria Kidney
  • Clinical Research & Consulting Center, LLC
  • KfH Nierenzentrum/Bad/Konig
  • KfH Nierenzentrum
  • KfH Dialysezentrum/Berlin
  • KfH Nierenzentrum/Dulmen
  • Georg-August-Universitat Universitatsmedizin Abt. Nephrologie u. Rheumatologie
  • Dialysezentrum Barmbeck
  • KfH-Nierenzentrum/Jena
  • KfH-Dialysezentrum/Rosenheim
  • Jose Cangiano, MD
  • Churchill Hospital Oxford Kidney Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Fosrenol (Lanthanum carbonate)

Sevelamer hydrochloride

Outcomes

Primary Outcome Measures

Change From Baseline in Serum Phosphorus Levels at 4 Weeks

Secondary Outcome Measures

Change From Baseline in Serum Calcium Levels at 4 Weeks
Levels of Intact Parathyroid Hormone (iPTH) at Baseline and 4 Weeks
Patients Achieving Kidney Disease Outcomes Quality Initiative (KDOQI) Target for Serum Phosphorous at 4 Weeks
Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous is 3.5 - 5.5 mg/dL (1.13 - 1.77 mmol/L)

Full Information

First Posted
February 27, 2007
Last Updated
June 4, 2021
Sponsor
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT00441545
Brief Title
Head to Head Study Against Sevelamer Hydrochloride
Official Title
A Prospective, Multicenter, Open-label, Randomized, Cross-over Study to Compare the Efficacy and Safety of Fosrenol® and Sevelamer Hydrochloride in Patients Receiving Hemodialysis for End Stage Renal Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 5, 2007 (Actual)
Primary Completion Date
July 31, 2008 (Actual)
Study Completion Date
July 31, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire

4. Oversight

5. Study Description

Brief Summary
To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.
Detailed Description
To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Stage 5

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Fosrenol (Lanthanum carbonate)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Sevelamer hydrochloride
Intervention Type
Drug
Intervention Name(s)
Fosrenol (Lanthanum Carbonate)
Other Intervention Name(s)
FOSRENOL
Intervention Description
The starting dose is a total daily dose of 2250mg of Fosrenol (Lanthanum carbonate) to a maximum dose of 3000mg daily. Chewable tablets will be administered orally with meals in 750mg and 1000mg strength tablets.
Intervention Type
Drug
Intervention Name(s)
Sevelamer hydrochloride
Intervention Description
The starting dose is a total daily dose of 4800mg of sevelamer hydrochloride up to a maximum of 6400 mg daily. Sevelamer hydrochloride 800mg tablets, administered orally with meals.
Primary Outcome Measure Information:
Title
Change From Baseline in Serum Phosphorus Levels at 4 Weeks
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Serum Calcium Levels at 4 Weeks
Time Frame
4 weeks
Title
Levels of Intact Parathyroid Hormone (iPTH) at Baseline and 4 Weeks
Time Frame
Baseline and 4 weeks
Title
Patients Achieving Kidney Disease Outcomes Quality Initiative (KDOQI) Target for Serum Phosphorous at 4 Weeks
Description
Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous is 3.5 - 5.5 mg/dL (1.13 - 1.77 mmol/L)
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults with end stage renal disease who are receiving dialysis Exclusion Criteria: Subjects with significant gastrointestinal disorders Subjects who are pregnant or nursing Subjects currently taking lanthanum carbonate, sevelamer hydrochloride, cinacalcet hydrochloride Subjects who are HIV positive Subjects with clinical significant liver disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
DSI Renal Inc.
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85202
Country
United States
Facility Name
AKDHC Medical Research Services, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Southwest Kidney Institute, PLC
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85284
Country
United States
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85284
Country
United States
Facility Name
University of Arizona Health Service Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Clinical Research Connections
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
South Valley Dialysis Center
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
VA Greater Los Angeles Health Care System, West LA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Apex Research of Riverside
City
Riverside
State/Province
California
ZIP/Postal Code
92505
Country
United States
Facility Name
North Valley Nephrology
City
Yuba City
State/Province
California
ZIP/Postal Code
95991
Country
United States
Facility Name
Western Nephrology & Metabolic Bone Disease, PC
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80260
Country
United States
Facility Name
Shands University of Florida Outpatient Dialysis
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Discovery Medical Research Group
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Pines Clinical Research
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Clinical Research Center of Indian River Medical Center
City
Vero Beach
State/Province
Florida
Country
United States
Facility Name
Kidney Care Associates, LLC
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
Renal Physicians of Georgia
City
Macon
State/Province
Georgia
ZIP/Postal Code
31217
Country
United States
Facility Name
Evanston Northwestern Hospital
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Research by Design, LLC
City
Evergreen Park
State/Province
Illinois
ZIP/Postal Code
60805
Country
United States
Facility Name
Nephrology Inc.
City
Mishawaka
State/Province
Indiana
ZIP/Postal Code
46545
Country
United States
Facility Name
Renal Associates of Baton Rouge
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Creighton University Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Hypertension and Nephrology, Associates
City
Eatontown
State/Province
New Jersey
ZIP/Postal Code
07724
Country
United States
Facility Name
Winthrop Dialysis Center
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
SUNY at Stony Brook NY
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Wake Nephrology Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Southeastern Nephrology Associates
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Northwest Renal Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Carolina Nephrology, PA
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
VA Tennessee Valley Healthcare System
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Rosa Verde Tower
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio Medicine/Nephrology
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Alexandria Kidney
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22304
Country
United States
Facility Name
Clinical Research & Consulting Center, LLC
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22030
Country
United States
Facility Name
KfH Nierenzentrum/Bad/Konig
City
Bad Konig
ZIP/Postal Code
64732
Country
Germany
Facility Name
KfH Nierenzentrum
City
Berlin
ZIP/Postal Code
10559
Country
Germany
Facility Name
KfH Dialysezentrum/Berlin
City
Berlin
ZIP/Postal Code
12045
Country
Germany
Facility Name
KfH Nierenzentrum/Dulmen
City
Dulmen
ZIP/Postal Code
48249
Country
Germany
Facility Name
Georg-August-Universitat Universitatsmedizin Abt. Nephrologie u. Rheumatologie
City
Gottingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Dialysezentrum Barmbeck
City
Hamburg
ZIP/Postal Code
22297
Country
Germany
Facility Name
KfH-Nierenzentrum/Jena
City
Jena
ZIP/Postal Code
07751
Country
Germany
Facility Name
KfH-Dialysezentrum/Rosenheim
City
Rosenheim
ZIP/Postal Code
83022
Country
Germany
Facility Name
Jose Cangiano, MD
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Facility Name
Churchill Hospital Oxford Kidney Unit
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19825330
Citation
Sprague SM, Ross EA, Nath SD, Zhang P, Pratt RD, Krause R. Lanthanum carbonate vs. sevelamer hydrochloride for the reduction of serum phosphorus in hemodialysis patients: a crossover study. Clin Nephrol. 2009 Oct;72(4):252-8. doi: 10.5414/cnp72252.
Results Reference
background
Links:
URL
http://www.fda.gov/opacom/7alerts.html
Description
FDA recall information

Learn more about this trial

Head to Head Study Against Sevelamer Hydrochloride

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