Rituximab Therapy for Patients on Kidney Transplant Waiting List With Positive Donor Specific Crossmatch to Living Donor

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00476515
• Date of registration: 18/05/2007
• Primary sponsor: Massachusetts General Hospital
• Public title: Rituximab Therapy for Patients on Kidney Transplant Waiting List With Positive Donor Specific Crossmatch to Living Donor
• Scientific title: Multicenter Trial Using Multi-Dose Rituximab as Induction and Desensitization Therapy for Patients on the Waiting List for Kidney Transplant With a Positive Donor Specific Crossmatch to a Living Donor
• Date of first enrolment: March 2007
• Target sample size: 0
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00476515
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Nina Tolkoff-Rubin, MD
• Affiliation: Massachusetts General Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Active status on a kidney transplant waiting list for over 2 years

- Donor specific antibody titer <= 1:128 (Class I, Class II or both) by cytotoxicity

- Signed and dated informed consent

- Age = 18 years

- Positive cross-match against a living donor

Exclusion Criteria:

- Donor specific antibody titer greater than 1:128 (Class I, Class II or both) by
cytotoxicity

- Inactive status on a kidney transplant list

- 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

- Positive history of HIV

- Positive history of Hepatitis B and/or Hepatitis C

- 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

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

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

- 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

- 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)

- Laboratory Exclusion Criteria (at Screening)

- Hemoglobin: < 7g/dL

- Platelets: <100,000/mm3

- AST or ALT >2X Upper limit of normal

- Known history of positive Hepatitis B or C serology

- Immunization status to be confirmed per transplant protocol. Review of the subject's
immunization status for the following vaccinations will be ascertained: tetanus;
diptheria; influenza; pneumococcal polysaccharide; Varicella; measles, mumps and
rubella (MMR); and hepatitis B. Subjects who are considered to be at high risk for
hepatitis B virus (HBV) infection and for whom the investigator has determined that
immunization is indicated should complete the entire HBV vaccine series (per routine
dialysis protocol) at least 4 weeks prior to participation in the study.

Immunization with a live vaccine is specifically excluded during the study.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Kidney Insufficiency

Intervention(s)

Drug: Rituximab

Primary Outcome(s)

Subjects who convert to a negative donor specific crossmatch or eliminate donor specific antibody will be considered a TREATMENT SUCCESS and will undergo target living donor transplantation in 3-5 days [Time Frame: 4 weeks after the final dose of Rituximab]

Secondary ID(s)

2006P002059

U2672s

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Biogen Idec

Genentech