Project

Comparison of ATG-Fresenius S to Thymoglobulin in prophylaxis for immunological high risk patients following renal transplantion

Completed · 2009 until 2010

Type
Clinical Studies
Range
Multicentric, KSSG as participating partner
Units
Status
Completed
Start Date
2009
End Date
2010
Financing
Self Financed
Study Design
Open, multicenter, randomised, parallel group pilot study
Keywords
ATG-Fresenius, Thymoglobulin, Inductionstherapie
Partner
Universitätsspital Basel
Brief description/objective

Two poyclonal depleting antibody products as an immunosuppresive induction therapy will be compared regarding safety profile and efficacy in immunological high risk patients after renal transplantion.

1. a regimen consisting of a triple drug therapy with Tacrolimus, MMF, and steroids as basis therapy plus IVIG for 5 days (total dose 2g/kg bw. max. 140g). in addition, the patients receive intra-operative 9 mg/kg bw.ATG-Fresenius S (completed before reperfusion), followed by 3 mg/kg bw/d for the next 4 consecutive days.

2. a regimen consisting of a triple drug therapy with Tacrolimus, MMF, and steroids as basis therapy plus IVIG for 5 days (total dose 2g/kg bw. max. 140g). in addition, the patients receive intra-operative 1.5 mg/kg bw Thymoglobulin (completed before reperfusion), followed by 1.5mg/kg bw/d for the next 3 consecutive days.