Completed

Phase 4
Age: 18Years +
All Genders
ID00324571

A Randomized, Open Label, Parallel Design Study of Renagel® Phosphate Binder Versus Calcium-Based Phosphate Binders in Hemodialysis Patients

Led by Genzyme, a Sanofi Company · Updated on 2015-03-18

2000

Participants Needed

73

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a randomized, open-label, parallel-design study to be conducted at 75 centers within the United States. The study will be described to hemodialysis patients. Informed consent will be obtained and the inclusion/exclusion criteria reviewed. Eligible patients will be randomized to receive either Renagel or a calcium-based binder. Starting from the randomization date, mortality data including survival, death date and cause of death (vital status information) and morbidity data including hospitalization date will be recorded for all patients. These data will be collected until the end of the study (December 31, 2004, ± 2 weeks). Patients completing or terminating from the study will return to the phosphate binder prescribed by their usual healthcare provider.

CONDITIONS

Brief Title

Dialysis Clinical Outcomes Revisited (DCOR) Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • patients must be 18 years of age or older,
  • on dialysis for more than 3 months,
  • require phosphate binder therapy,
  • have Medicare as their primary insurance.
Not Eligible

You will not qualify if you...

  • dysphagia,
  • swallowing disorders,
  • severe gastrointestinal motility disorders,
  • bowel obstruction.

Trial Site Locations

Total: 73 locations

1

Gambro Healthcare-Gadsden

Gadsden, Alabama, United States

Status Unknown

2

nTouch Research

Huntsville, Alabama, United States

Status Unknown

3

Kidney Health Institute, LLC

Tucson, Arizona, United States

Status Unknown

4

Gambro Healthcare

El Cerrito, California, United States

Status Unknown

5

Palomar Medical Group

Escondido, California, United States

Status Unknown

6

Gambro Healthcare-Los Angeles

Los Angeles, California, United States

Status Unknown

7

Balboa Nephrology Medical Group

San Diego, California, United States

Status Unknown

8

Nephrology Educational Services and Research

Tarzana, California, United States

Status Unknown

9

Lowry Dialysis Center

Denver, Colorado, United States

Status Unknown

10

Nephrology Associates, P.C.

Bridgeport, Connecticut, United States

Status Unknown

11

Gambro Healthcare-Hartford

Hartford, Connecticut, United States

Status Unknown

12

Nephrology Associates

New Britain, Connecticut, United States

Status Unknown

13

InterAmerican Dialysis

Coral Gables, Florida, United States

Status Unknown

14

DaVita Crystal River Dialysis

Crystal River, Florida, United States

Status Unknown

15

Gambro Healthcare-Miami

Miami, Florida, United States

Status Unknown

16

Miami Kidney Group

Miami, Florida, United States

Status Unknown

17

Pensacola Nephrology, P.A.

Pensacola, Florida, United States

Status Unknown

18

Gambro Healthcare-Plantation

Plantation, Florida, United States

Status Unknown

19

America Dialysis

St. Petersburg, Florida, United States

Status Unknown

20

Genesis Clinical Research Corp

Tampa, Florida, United States

Status Unknown

21

Gambro Healthcare-Americus

Americus, Georgia, United States

Status Unknown

22

nTouch Research

Atlanta, Georgia, United States

Status Unknown

23

Gambro Healthcare-Douglas

Douglas, Georgia, United States

Status Unknown

24

Gambro Healthcare-Douglasville

Douglasville, Georgia, United States

Status Unknown

25

Dublin Nephrology

Dublin, Georgia, United States

Status Unknown

26

Georgia Kidney Associates, Inc.

Marietta, Georgia, United States

Status Unknown

27

Gambro Healthcare-Rome

Rome, Georgia, United States

Status Unknown

28

Gambro Healthcare-Savannah

Savannah, Georgia, United States

Status Unknown

29

MacNeal Renal Lifeline Services

Berwyn, Illinois, United States

Status Unknown

30

Southwest Nephrology

Evergreen Park, Illinois, United States

Status Unknown

31

Horizon Healthcare Associates

Olympia Fields, Illinois, United States

Status Unknown

32

Renal Care Associates, S.C.

Peoria, Illinois, United States

Status Unknown

33

Gambro Healthcare-Springfield Central

Springfield, Illinois, United States

Status Unknown

34

Lincolnland Dialysis

Springfield, Illinois, United States

Status Unknown

35

Nephrology Specialists, PC.

Valparaiso, Indiana, United States

Status Unknown

36

Wichita Dialysis Center East

Wichita, Kansas, United States

Status Unknown

37

Wichita Nephrology

Wichita, Kansas, United States

Status Unknown

38

Northwest Louisiana Nephrology, LLC.

Shreveport, Louisiana, United States

Status Unknown

39

BMA of Washington

Bethesda, Maryland, United States

Status Unknown

40

Gambro Healthcare-Frederick

Frederick, Maryland, United States

Status Unknown

41

Associates in Nephrology, P.C.

Brockton, Massachusetts, United States

Status Unknown

42

Western New England Renal and Transplant Associates, Inc.

Springfield, Massachusetts, United States

Status Unknown

43

DaVita Clinical Research

Minneapolis, Minnesota, United States

Status Unknown

44

Nephrology Associates, P.C.

Columbus, Mississippi, United States, 39705

Status Unknown

45

University of Missouri-Kansas City

Kansas City, Missouri, United States

Status Unknown

46

DaVita Crystal City Dialysis

St Louis, Missouri, United States

Status Unknown

47

Nephrology and Endocrine Associates

Las Vegas, Nevada, United States

Status Unknown

48

Bronx Westchester Medical Group

The Bronx, New York, United States

Status Unknown

49

Mountain Kidney Associates, P.A.

Asheville, North Carolina, United States

Status Unknown

50

nTouch Research

Raleigh, North Carolina, United States

Status Unknown

51

Wake Nephrology/Wake Dialysis Clinic

Raleigh, North Carolina, United States

Status Unknown

52

Gambro Healthcare-Wilson

Wilson, North Carolina, United States

Status Unknown

53

Kidney and Hypertension Center

Cincinnati, Ohio, United States, 45220

Status Unknown

54

Ohio State University College of Pharmacy

Columbus, Ohio, United States

Status Unknown

55

FMC of Bethlehem

Allentown, Pennsylvania, United States

Status Unknown

56

Fresenius Medical Care

Greensburg, Pennsylvania, United States

Status Unknown

57

Hypertension and Kidney Specialists

Lancaster, Pennsylvania, United States

Status Unknown

58

DaVita Lewistown Dialysis Center

Lewistown, Pennsylvania, United States

Status Unknown

59

Albert Einstein Medical Center

Philadelphia, Pennsylvania, United States, 19141

Status Unknown

60

P.C. & Associates

Philadelphia, Pennsylvania, United States

Status Unknown

61

Nesbitt College of Pharmacy and Nursing Department of Pharmacy Practice

Wilkes-Barre, Pennsylvania, United States

Status Unknown

62

Gambro Healthcare-Aiken

Aiken, South Carolina, United States

Status Unknown

63

Midsouth Nephrology Consultants

Memphis, Tennessee, United States

Status Unknown

64

Dallas Nephrology Associates

Dallas, Texas, United States

Status Unknown

65

Nephrology, Dialysis and Transplant Association

Houston, Texas, United States

Status Unknown

66

West Houston Dialysis

Houston, Texas, United States

Status Unknown

67

San Antonio Kidney Disease Center

San Antonio, Texas, United States

Status Unknown

68

Gambro Healthcare - Charlottesville

Charlottesville, Virginia, United States, 22902

Status Unknown

69

Clinical Research and Consulting Center, LLC

Fairfax, Virginia, United States

Status Unknown

70

Clinical Research of Tidewater

Norfolk, Virginia, United States, 23507

Status Unknown

71

Virginia Commonwealth University, Division of Nephrology

Richmond, Virginia, United States, 23298

Status Unknown

72

Vancouver Clinic Inc., P.S.

Vancouver, Washington, United States

Status Unknown

73

Clinical Las Americas

San Juan, Puerto Rico

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

0

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