I5NP for Prophylaxis of Delayed Graft Function in Kidney Transplantation

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

374

Participants

Timeline

Start Date

December 31, 2008

Primary Completion Date

November 30, 2013

Study Completion Date

May 31, 2014

Conditions
Delayed Graft FunctionOther Complication of Kidney Transplant
Interventions
DRUG

I5NP

"Single IV injection of I5NP~Part A: dose-escalation study; cohort 1 = 0.5 mg/kg; cohort 2 = 1.5 mg/kg; cohort 3 = 5.0 mg/kg; cohort 4 = 10.0 mg/kg~Part B: 10.0 mg/kg"

DRUG

Saline

"Single IV injection of saline~Part A: dose-escalation study; cohort 1 = 0.5 mg/kg; cohort 2 = 1.5 mg/kg; cohort 3 = 5.0 mg/kg; cohort 4 = 10.0 mg/kg~Part B: 10.0 mg/kg"

Trial Locations (50)

10032

Columbia University, New York

10065

Cornell University, New York

20010

Washington Hospital Center, Washington D.C.

21201

University of Maryland, Baltimore

21205

Johns Hopkins University, Baltimore

22908

University of Virginia, Charlottesville

23298

Virginia Commonwealth University (MCV), Richmond

27157

Wake Forest University Medical Center, Winston-Salem

27710

Duke University, Durham

29425

Medical University of South Carolina, Charleston

30309

Piedmont Hospital, Atlanta

30322

Emory University, Atlanta

32610

University of Florida, Gainesville

33136

University of Miami, Miami

33606

Lifelink Healthcare Institute, Tampa

35294

University of Alabama Birmingham, Birmingham

48109

University of Michigan, Ann Arbor

55905

Mayo Clinic Rochester, Rochester

60612

Rush University, Chicago

University of Illinois Chicago, Chicago

75246

Baylor University Medical Center, Dallas

76104

Baylor All Saints Medical Center, Fort Worth

77030

The Methodist Hospital, Houston

80045

University of Colorado Health Science Center, Aurora

90033

University of Southern California, Los Angeles

90048

Cedars-Sinai Medical Center, Los Angeles

90057

Transplant Research Institute (TRI; formerly NIT), Los Angeles

90095

UCLA Medical Center, Los Angeles

92354

Loma Linda University Medical Center, Loma Linda

94115

California Pacific Medical Center, San Francisco

94143

UCSF Medical Center, San Francisco

95817

UC Davis Medical Center, Sacramento

07039

Saint Barnabas Medical Center, Livingston

Unknown

St. Paul's Hospital, Univeristy of BC, Vancouver

UBC - Division of Nephrology, Vancouver

QE II Capital District Health Authority, Halifax, Halifax

MUHC Royal Victoria Hospital, Montreal

Hôpital Pasteur, Nice

Hôpital Necker, Paris

CHU Rangueil, Toulouse

Charité - Universitätsmedizin Berlin, Berlin

Charité, Campus Virchow-Klinikum, Berlin

Kliniken der Stadt Köln gGmbH, Cologne

Universitätklinikum Hamburg-Eppendorf, Hamburg

Universitätsklinikum Heidelberg, Heidelberg

Universitätsmedizin Mannheim, Mannheim

Universitätsklinikum Tübingen, Tübingen

Hospital de bellvitge, Barcelona

Hospital del mar, Barcelona

Hospital Vall Hebron, Barcelona

Sponsors
All Listed Sponsors
lead

Quark Pharmaceuticals

INDUSTRY