Rituximab in Renal Allograft Recipients Who Develop Early De Novo Anti-HLA Alloantibodies

PHASE2CompletedINTERVENTIONAL
Enrollment

757

Participants

Timeline

Start Date

March 31, 2006

Primary Completion Date

December 31, 2012

Study Completion Date

December 31, 2012

Conditions
Kidney TransplantKidney Transplant RecipientGraft Function/Survivalde Novo HLA Antibodies Development
Interventions
DRUG

Rituximab plus immunosuppression

"Genetically engineered monoclonal antibody directed against the CD20 antigen on B cells and is known to deplete B cells when administered intravenously. Generally used in the treatment of non-Hodgkin's lymphoma~Standard immunosuppression is site-specific."

DRUG

Placebo plus immunosuppression

"Placebo dosing: Adult Dosing (Subjects \>18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject \<\\=18 years): 375 mg/m\^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression is site-specific."

Trial Locations (17)

19104

Children's Hospital of Philadelphia, Philadelphia

21201

University of Maryland, Baltimore

32601

University of Florida, Gainesville

35294

University of Alabama, Pediatric Nephrology, Birmingham

University of Alabama, Birmingham

60607

University of Illinois, Chicago

60611

Northwestern University, Chicago

77030

The Methodist Hospital, Houston

94143

University of California, San Francisco, San Francisco

97210

Legacy Transplant Services, Portland

97219

Oregon Health Science University, Portland

98105

Children's Hospital and Regional Medical Center, Seattle

02114

Massachusetts General Hospital, Boston

02115

Brigham and Women's Hospital, Boston

Children's Hospital Boston, Boston

02215

Beth Israel Deaconess Medical Center, Boston

07039

Saint Barnabas Medical Center, Livingston

All Listed Sponsors
collaborator

Clinical Trials in Organ Transplantation

NETWORK

collaborator

Cooperative Clinical Trials in Pediatric Transplantation (CCTPT)

UNKNOWN

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT00307125 - Rituximab in Renal Allograft Recipients Who Develop Early De Novo Anti-HLA Alloantibodies | Biotech Hunter | Biotech Hunter