Comparative Study of Modified Release (MR) Tacrolimus/Mycophenolate Mofetil (MMF) in de Novo Kidney Transplant Recipients

PHASE3CompletedINTERVENTIONAL
Enrollment

668

Participants

Timeline

Start Date

June 30, 2003

Primary Completion Date

March 31, 2005

Study Completion Date

March 31, 2009

Conditions
Kidney Transplantation
Interventions
DRUG

Tacrolimus Modified Release (MR)

The target range for whole blood tacrolimus trough concentrations was 7 to 16 ng/mL for days 0 through 90, and 5 to 15 ng/mL thereafter.

DRUG

Tacrolimus

The target range for whole blood tacrolimus trough concentrations was the recommended trough concentration range for Prograf: 7 to 16 ng/mL for days 0 through 90 and 5 to 15 ng/mL thereafter.

DRUG

cyclosporine microemulsion

The target range for whole blood cyclosporine trough concentrations was 125 to 400 ng/mL for days 0 through 90, and 100 to 300 ng/mL thereafter.

DRUG

mycophenolate mofetil

Oral

Trial Locations (57)

10029

New York

10595

Valhalla

12208

Albany

14203

Buffalo

17104

Harrisburg

19104

Philadelphia

19107

Philadelphia

20010

Washington D.C.

22031

Fairfax

27710

Durham

30912

Augusta

32216

Jacksonville

35294

Birmingham

36617

Mobile

40536

Lexington

45267

Cincinnati

46202

Indianapolis

48202

Detroit

53226

Milwaukee

60612

Chicago

60637

Chicago

70112

New Orleans

70121

New Orleans

75235

Dallas

75246

Dallas

77030

Houston

80262

Denver

84132

Salt Lake City

90033

Los Angeles

90057

Los Angeles

90058

Los Angeles

92103

San Diego

92123

San Diego

92354

Loma Linda

94115

San Francisco

94304

Palo Alto

97210

Portland

90095-7306

Los Angeles

32610-0224

Gainesville

02214

Boston

48109-0364

Ann Arbor

07039

Livingston

08901

New Brunswick

27599-7211

Chapel Hill

97239-2940

Portland

37212-4750

Nashville

78229-3900

San Antonio

53792-7375

Madison

90240-520

Porto Alegre

21041-003

Rio de Janeiro

04013-043

São Paulo

04038-002

São Paulo

05465-040

São Paulo

Unknown

Edmonton

Vancouver

Toronto

Montreal

Sponsors
All Listed Sponsors
lead

Astellas Pharma Inc

INDUSTRY