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Clinical Trials/NCT00861536
NCT00861536
Completed
Phase 4

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 Thymoglobulin in Prophylaxis for Immunological High Risk Patients Following Renal Transplantation

University Hospital, Basel, Switzerland1 site in 1 country40 target enrollmentStarted: January 2009Last updated:
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ConditionsTransplantation, Kidney
InterventionsATG FreseniusThymoglobuline Genzyme
DrugsATG FreseniusThymoglobuline Genzyme

Overview

Phase
Phase 4
Status
Completed
Sponsor
University Hospital, Basel, Switzerland
Enrollment
40
Locations
1
Primary Endpoint
Adverse events
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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 Thymoglobulin in prophylaxis for immunological high risk patients following renal transplantation. This non-inferiority trial shall demonstrate that ATG-Fresenius S is as efficacious as Thymoglobulin but has a better tolerance and fewer side effects.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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 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 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.

Arms & Interventions

ATG Fresenius

Experimental

Intervention: ATG Fresenius (Drug)

Thymoglobuline Genzyme

Active Comparator

Intervention: Thymoglobuline Genzyme (Drug)

Outcomes

Primary Outcomes

Adverse events

Time Frame: Daily

Secondary Outcomes

  • Rejection(Daily)
  • Patient survival(Daily)
  • Graft function(Daily)
  • Graft survival(Daily)

Investigators

Sponsor
University Hospital, Basel, Switzerland
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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