B Cell Induction in Pediatric Lung Transplantation

Part of paid clinical trials in Palo Alto, California.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT02266888
Phase
PHASE2
Status
Completed

Conditions

  • Lung Transplant

Eligibility Criteria

Sex
ALL
Age
N/A - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab (Rituxan®) — BIOLOGICAL
    2 Doses: 375 mg/m\^2 on Day 0 (within 12 hours of return to ICU following transplant) and Day 12 (+/-2 days).
  • Placebo — BIOLOGICAL
    Placebo for Rituximab (Rituxan®). 2 Doses: 375 mg/m\^2 on Day 0 (within 12 hours of return to ICU following transplant) and Day 12 (+/-2 days).

Study Details

In this study, doctors are trying to see if a study drug called rituximab (Rituxan®) will lower the number of B cells in the body. Doctors are also trying to see if decreasing B cells with rituximab (Rituxan®) can prevent injury to the transplanted lung. This treatment has been studied in other types of solid organ transplants.

Key Dates

Start date
Jan 22, 2015
Status verified
Oct 2021
Primary completion
Jun 30, 2019
Completion
Jun 30, 2019

Study Design

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

Arms

  • Experimental: Rituximab Induction
    Rituximab (Rituxan®) Induction Therapy Plus Standard of Care Immunosuppression (thymoglobulin induction, tacrolimus or equivalent, mycophenolate mofetil (MMF) or equivalent, and steroids)
  • Placebo Comparator: Placebo Induction
    Placebo Induction Therapy Plus Standard of Care Immunosuppression (Thymoglobulin® induction, tacrolimus or equivalent, mycophenolate mofetil (MMF) or equivalent, and steroids)

Primary Outcome Measure

Earliest Time to Any of the Following Events: Chronic Allograft Dysfunction, Listed for Retransplant or Death [ Time Frame: Up to 35 months post-transplant ]

Locations (7)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94305-
Children's Hospital BostonBostonMassachusetts02115-
Washington UniversitySt LouisMissouri63110-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
Nationwide Children's HospitalColumbusOhio43205-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
Texas Children's HospitalHoustonTexas77030-

Find similar trials in Palo Alto, CA

By research site
Stanford University· Palo Alto, CAChildren's Hospital Boston· Boston, MAWashington University· St Louis, MOCincinnati Children's Hospital Medical Center· Cincinnati, OHNationwide Children's Hospital· Columbus, OHChildren's Hospital of Philadelphia· Philadelphia, PA

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