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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT00307125
Phase
PHASE2
Status
Completed

Conditions

  • Graft Function/Survival
  • Kidney Transplant
  • Kidney Transplant Recipient
  • de Novo HLA Antibodies Development

Eligibility Criteria

Sex
ALL
Age
5 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab plus immunosuppression — DRUG
    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.
  • Placebo plus immunosuppression — DRUG
    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.

Study Details

The purpose of this study is to determine whether treatment with rituximab (anti-CD20, Rituxan®, MabThera®) in individuals who develop new anti-HLA antibodies after renal (kidney) transplant will promote longer-term survival of the transplanted kidney.The pilot study compares the use of rituximab (Rituxan®) + site-specific standard immunosuppression to placebo + site-specific standard immunosuppression in the treatment of circulating anti-HLA antibodies in subjects who develop de novo anti-HLA antibodies between 3-36 months after transplant.

Key Dates

Start date
Mar 31, 2006
Status verified
Mar 2015
Primary completion
Dec 31, 2012
Completion
Dec 31, 2012

Study Design

Enrollment
757 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pilot Phase-Rituximab plus immunosuppression
    Enrollment into a Stage 2 pilot treatment study will occur after Stage 1. Adult Rituximab Dosing (Subjects \> 18 years): 1000 mg on days 0 and 14; Pediatric Rituximab Dosing (Subjects \<\\=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.
  • Placebo Comparator: Pilot Phase-Placebo plus immunosuppression
    Adult Placebo Dosing (Subjects \>18 years): 1000 mg on days 0 and 14; Pediatric Placebo 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.

Primary Outcome Measure

During Screening Phase: Incidence of Alloantibody Development [ Time Frame: During screening window of 3-60 months post kidney transplant ]

Locations (17)

FacilityCityStateZIPSite coordinators
University of AlabamaBirminghamAlabama35294-
University of Alabama, Pediatric NephrologyBirminghamAlabama35294-
University of California, San FranciscoSan FranciscoCalifornia94143-
University of FloridaGainesvilleFlorida32601-
Northwestern UniversityChicagoIllinois60611-
University of IllinoisChicagoIllinois60607-
University of MarylandBaltimoreMaryland21201-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Brigham and Women's HospitalBostonMassachusetts02115-
Children's Hospital BostonBostonMassachusetts02115-
Massachusetts General HospitalBostonMassachusetts02114-
Saint Barnabas Medical CenterLivingstonNew Jersey07039-
Legacy Transplant ServicesPortlandOregon97210-
Oregon Health Science UniversityPortlandOregon97219-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
The Methodist HospitalHoustonTexas77030-
Children's Hospital and Regional Medical CenterSeattleWashington98105-

Find similar trials in Birmingham, AL

By research site
University of Alabama· Birmingham, ALUniversity of Alabama, Pediatric Nephrology· Birmingham, ALUniversity of California, San Francisco· San Francisco, CAUniversity of Florida· Gainesville, FLNorthwestern University· Chicago, ILUniversity of Illinois· Chicago, IL

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