Status:
COMPLETED
An Open, Single Centre, Randomised, Parallel Group Study to Investigate Three Different Immunosuppressive Regimens
Lead Sponsor:
University Hospital, Basel, Switzerland
Collaborating Sponsors:
Novartis
Conditions:
Comparative Study
Immunosuppressive Agents
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
An open, single center, randomised study to investigate three different immunosuppressive regimens for de novo renal transplant recipients: 1. st sirolimus / EC-MPS / tacrolimus regimen \- After ...
Detailed Description
This study is designed to show similar efficacy but a different adverse event profile between the three regimens. Its main purpose is to provide more information, if steroid free immunosuppressive tre...
Eligibility Criteria
Inclusion
- Male or female patients between 18 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 centre.
- Patient has been fully informed and has given written or independent person witnessed oral informed consent.
Exclusion
- in 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 donor specific HLA-antibodies 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 \> 75 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, everolimus, tacrolimus, Sirolimus or EC-MPS.
- 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 the protocol.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT01183247
Start Date
July 1 2008
End Date
June 1 2010
Last Update
August 17 2010
Active Locations (1)
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1
Clinic for transplantation immunology and nephrology
Basel, Switzerland, 4031