Calcineurin Free Immunosuppression in Renal Transplant Recipients

• Status: Completed
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to obtain preliminary information on the efficacy, safety and cost of two regimens, Rapamycin / MMF / steroid therapy and Cyclosporine A Neoral / MMF / steroid therapy, used in the prevention of acute rejection following renal transplantation.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Basel, Switzerland
• Collaborator: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Cyclosporine; Cyclosporins; Everolimus; Immunosuppressive Agents; Mycophenolate mofetil; Mycophenolic Acid; Prednisone; Sirolimus

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 leukocytes.

• Patient has thrombocytopenia, defined as having at transplantation less than 75000/mm3 thrombocytes.

• 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 antibody preparation(s).

• 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 kidney.

• Patient is unlikely to comply with the visits schedule in the protocol.