ABOUT THIS STUDY
- Male or female patients between 15 and 75 years of age, regardless of race.
- Female patients of child bearing age agree to maintain effective birth control practice during the study.
- Patient has end stage kidney disease and is a suitable candidate for primary renal transplantation or retransplantation as assessed by the transplantation center.
- Patient has been fully informed and has given written or independent person witnessed oral informed consent.
- Patient is pregnant or breastfeeding.
- Patient has a low immunological risk constellation, defined by receiving a kidney from
a HLA-identical related living donor.
- Patient has a high immunological risk constellation, defined as having within the
previous three years a measured PRA grade of ≥25% and/or having a previous graft
survival shorter than 3 years due to rejection.
- Patient and donor have a positive T or B-cell crossmatch.
- Patient and donor are ABO incompatible.
- Age of donor > 68 years.
- Cold ischemia time > 36 hours.
- Patient has leucopenia, defined as having at transplantation less than 3000/mm3
- Patient has thrombocytopenia, defined as having at transplantation less than 75000/mm3
- Patient is allergic or intolerant to cremophor RH 60 or structurally related
compounds, steroids, Cyclosporine A Neoral, Rapamycin or MMF.
- Patient requires initial sequential or parallel therapy with immunosuppressive
- Patient or donor is known to be HIV positive.
- Patient has significant liver disease, defined as having during the past 28 days
continuously ASAT (SGOT) and/or ALAT (SGPT) levels greater than 3 fold of the upper
value of the normal range of the investigational site.
- Patient with malignancy or history of malignancy ≥ 2 years, except non metastatic
basal or squamous cell carcinoma of the skin that has been treated successfully.
- Patient has significant, uncontrolled concomitant infections and/or severe diarrhea,
vomiting, or active peptic ulcer.
- Patient is taking or has been taking an investigational drug in the past 28 days.
- Patient has previously received or is receiving another organ transplant other than
- Patient is unlikely to comply with the visits schedule in the protocol.
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in