Effects of Rituximab and Mycophenolate Mofetil (MMF) on Highly Sensitized Patients Awaiting Renal… (NCT00446251) | Clinical Trial Compass
CompletedPhase 2
Effects of Rituximab and Mycophenolate Mofetil (MMF) on Highly Sensitized Patients Awaiting Renal Transplant
14 participantsStarted 2006-12
Plain-language summary
This is a 12-month phase 2, prospective, open label study to evaluate the effect of rituximab with mycophenolate mofetil (MMF)on the PRA of 14 highly sensitized patients who just completed an 8 month trial of MMF treatment alone. PRA values obtained at study enrollment and at 6 and 12 months on combined therapy as well as the rates of transplant will be compared and evaluated using descriptive analysis.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Age range 18 - 75, inclusive
* Able and willing to give written informed consent and comply with the requirements of the study protocol
* Outpatient status
* Patients with a Panel of Reactive Antibodies (PRA) over 10% after an 8-month trial of MMF monotherapy
* Patients with updated immunizations for tetanus, influenza, hepatitis B, pneumococcus
* Patients with a negative purified protein derivative(PPD ) screen for tuberculosis (TB)within the last 6 months. If subject has a prior history of TB or positive PPD, documentation of adequate treatment is required.
* Women who are of childbearing potential must have a negative serum pregnancy test prior to being enrolled in the study and agree to use a medically acceptable method of contraception throughout the study and for twelve months (1 year) after completion of treatment.
* Men must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment.
* Liver enzymes ALT and AST less than 2 times the normal limit.
Exclusion Criteria:
* Active infection
* Receipt of live vaccine within 4 weeks prior to first infusion.
* Previous treatment with rituximab (MabThera® / Rituxan®)
* History of multiple recurrent infections defined as more than 3 urinary tract infections, 2 episodes of pneumonia or 3 episodes of otitis/sinusitis in one year, or more than two dialysis line or peritoneal infections within one year.
* Infection with hepatitis C virus (…
What they're measuring
1
The Number of Subjects Who Experience a Decrease in Their Panel of Reactive Antibodies (PRA) at 6 Months Post Rituximab Infusion.