Status:
COMPLETED
Comparison of ATG to Thymoglobuline in Renal Transplantation
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
Transplantation, Kidney
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
An open, multicenter, randomised, parallel group pilot study to investigate two different polyclonal rabbit immunoglobulin preparations for safety and efficacy: A comparison of ATG-Fresenius S to Thym...
Eligibility Criteria
Inclusion
- Recipients, who are at least 18 years or older and have a high immunological risk defined by:
- The presence of at least one donor-specific antibody (class I and/or II) detected and specified by flow-technology (FlowPRA and single antigen beads), which are
- For class I below the threshold of detection of a current CDC T-cell-/ and B-cell cross-match
- For class II below the threshold of detection of a current CDC B-cell cross-match.
- Patient receives a renal allograft only.
- Female patients of child bearing age agree to maintain effective birth control practice during the study.
- Patient has been fully informed and has given written or independent person witnessed oral informed consent.
Exclusion
- 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 and donor have a positive T-cell crossmatch.
- Patient and donor are ABO incompatible.
- Patient with combined transplantation.
- Age of donor \>75 years.
- Cold ischemia time \>40 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 ATG-Fresenius S, Thymoglobulin, steroids, Tacrolimus or MMF.
- EBV risk constellation (recipient EBV negative and donor EBV positive).
- Patient or donor is known to be HIV positive.
- Patient has a liver disease, defined as continuously having ASAT (SGOT) and/or ALAT (SGPT) levels greater than 3fold of the upper value of the normal range of the investigational site during the past 28 days.
- 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 uncontrolled concomitant infections and/or severe diarrhea, vomiting, or active peptic ulcer.
- Patient is unlikely to comply with the visits schedule in the protocol.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00861536
Start Date
January 1 2009
End Date
February 1 2015
Last Update
April 14 2015
Active Locations (1)
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1
University Hospital Basel, Transplantation Immunology and Nephrology
Basel, Switzerland, 4031