Clinical trial NCT00697996 (phase 2/phase 3, status: completed)
Conditions: kidney transplantation
ICD codes: N26.2, Q63.0, Q63.2, Z52.4, I75.81, N19, N20.0
Drugs: rituximab for transplant rejection
SMILES: ClCCN(CCCl)P1(=O)NCCCO1
Eligibility 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.&#xA;

        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