Rituximab for Pediatric Renal Transplant Rejection

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Rituximab will be tested for its safety and potential efficacy in treating B cell dense renal allograft rejection episodes in children receiving renal transplants at Stanford University

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborator: Genentech and Biogen IDEC
• Treatments: Rituximab

Criteria

Inclusion Criteria:Patients must meet the following inclusion criteria to be eligible for study entry:

• Pediatric renal allograft recipients aged 2-21 years with biopsy proven acute rejection episodes.

• Able and willing to give written informed consent and comply with the requirements of the study protocol (patients >18 years of age or parents)

• Greater than 30% decline in baseline renal function as indicated by a rise in the serum creatinine.

• Adequate liver function, as indicated by AST or ALT <2x upper limit of normal unless related to primary disease.

• Negative serum pregnancy test (for women of child bearing age)

• Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment.

Exclusion Criteria:Patients will be excluded from the study based on the following criteria:

• Treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer)

• Receipt of a live vaccine within 4 weeks prior to randomization

• Previous Treatment with Rituximab (MabThera® / Rituxan®)

• History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies

• History of HIV (positive HIV, HIV conducted during screening if applicable)

• History of Hepatitis B and/or Hepatitis C (Hep B/C at screening)

• History of recurrent significant infection or history of recurrent bacterial infections

• Known active bacterial, viral, fungal, mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening

• Ongoing use of high dose steroids (>10mg/day) or unstable steroid dose in the past 4 weeks.

• Lack of peripheral venous access

• History of drug, alcohol, or chemical abuse within 6 months prior to screening

• Pregnancy (a negative serum pregnancy test should be performed for all women of childbearing potential within 7 days of treatment) or lactation

• Concomitant malignancies or previous malignancies within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.

• History of psychiatric disorder

• Significant cardiac or pulmonary disease (including obstructive pulmonary disease)

• Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications

• Inability to comply with study and follow-up procedures