Enteric-coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) in Renal Transplant Patients With Gastrointestinal (GI) Intolerance

PHASE4CompletedINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

October 31, 2006

Primary Completion Date

June 30, 2008

Conditions
Renal Transplantation
Interventions
DRUG

Enteric-coated mycophenolate sodium (EC-MPS)

Enteric-coated mycophenolate sodium supplied as 180 mg tablets.

DRUG

Mycophenolate mofetil

Mycophenolate mofetil supplied as 250 mg capsules.

DRUG

Placebo to mycophenolate sodium

Placebo to mycophenolate sodium matching tablets.

DRUG

Placebo to mycophenolate mofetil

Placebo to mycophenolate mofetil matching capsules.

Trial Locations (53)

10467

Montefiore Medical Center, The Bronx

17105

Pinnacle Health at Harrisburg Hospital, Harrisburg

19107

Thomas Jefferson University Hospital, Philadelphia

20010

Washington Hospital Transplant Research, Washington D.C.

21201

University of Maryland, Baltimore

21205

The Johns Hopkins Hospital, Baltimore

21228

Mid-Atlantic Nephrology Associates, Baltimore

23298

Virginia Commonwealth University, Richmond

27157

Wake Forest, Winston-Salem

27834

East Carolina University, Greenville

29425

Medical University of South Carolina, Charleston

30309

Piedmont Hospital, Atlanta

30912

Medical College of Georgia, Augusta

38104

The University of Tennessee Health Science Center, Memphis

40536

University of Kentucky Medical Center, Lexington

44106

University Hospitals of Cleveland, Cleveland

44195

Cleveland Clinic, Cleveland

46202

Clarian Health Partners, Indianapolis

48202

Henry Ford Health System, Detroit

48236

St. John Hospital Medical Center, Detroit

55455

University of Minnesota, Minneapolis

60153

Loyola University Medical Center, Maywood

60637

University of Chicago Medical Center, Chicago

63110

Washington University School of Medicine, St Louis

64111

Univ of KS Medical Ctr, Kansas City

St. Luke's Hospital of Kansas City, Kansas City

68198

University of Nebraska Medical Center, Omaha

71101

Northwest Louisiana Nephrology Research, Shreveport

71103

WKHS/LSUHSC Regional Transplant Center, Shreveport

75230

CRSTI, Dallas

76104

Baylor All Saints, Fort Worth

80218

Denver Nephrology, Denver

80262

University of Colorado Health Science Center, Denver

84132

University of Utah Hospitals and Clinics, Salt Lake City

85012

AKDHC Medical Research Services, LLC, Phoenix

90033

University of Southern California, Los Angeles

90048

Cedars-Sinai Medical Center, Los Angeles

90057

National Institute of Transplantation, Los Angeles

90095

David Geffen School of Medicine at UCLA, Los Angeles

92103

University of California, San Diego, San Diego

94143

University of California, San Francisco

95817

UC Davis Medical Center, Sacramento

92103-8401

University of California San Diego, San Diego

06520

Yale University Transplantation, New Haven

32610-0224

University of Florida College of Medicine, Gainesville

02115

Brigham and Women's Hospital, Boston

07039

St. Baranabas Medical Center, Livingston

27599-7211

UNC Chapel Hill, Chapel Hill

97239-3098

Oregon Health & Science University, Portland

02903

Rhode Island Hospital, Providence

37232-2372

Vanderbilt University Medical Center, Nashville

77555-0533

University of Texas Medical Branch, Galveston

98195-6521

University of Washington, Seattle

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY