Comparison of ATG to Thymoglobuline in Renal Transplantation

April 13, 2015 updated by: University Hospital, Basel, Switzerland

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

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 Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Basel, Switzerland, 4031
        • University Hospital Basel, Transplantation Immunology and Nephrology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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.
  2. Patient receives a renal allograft only.
  3. Female patients of child bearing age agree to maintain effective birth control practice during the study.
  4. Patient has been fully informed and has given written or independent person witnessed oral informed consent.

Exclusion Criteria:

  1. Patient is pregnant or breastfeeding.
  2. Patient has a low immunological risk constellation, defined by receiving a kidney from a HLA-identical related living donor.
  3. Patient and donor have a positive T-cell crossmatch.
  4. Patient and donor are ABO incompatible.
  5. Patient with combined transplantation.
  6. Age of donor >75 years.
  7. Cold ischemia time >40 hours.
  8. Patient has leucopenia, defined as having at transplantation less than 3000/mm3 leukocytes.
  9. Patient has thrombocytopenia, defined as having at transplantation less than 75000/mm3 thrombocytes.
  10. Patient is allergic or intolerant to ATG-Fresenius S, Thymoglobulin, steroids, Tacrolimus or MMF.
  11. EBV risk constellation (recipient EBV negative and donor EBV positive).
  12. Patient or donor is known to be HIV positive.
  13. 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.
  14. 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.
  15. Patient has uncontrolled concomitant infections and/or severe diarrhea, vomiting, or active peptic ulcer.
  16. Patient is unlikely to comply with the visits schedule in the protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ATG Fresenius
Day 0: 9 mg/kg bw bolus Days 1-4: 3 mg/kg bw/d
ACTIVE_COMPARATOR: Thymoglobuline Genzyme
Day 0-3: 1.5 mg/kg bw/d

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: Daily
Daily

Secondary Outcome Measures

Outcome Measure
Time Frame
Rejection
Time Frame: Daily
Daily
Graft function
Time Frame: Daily
Daily
Patient survival
Time Frame: Daily
Daily
Graft survival
Time Frame: Daily
Daily

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Juerg Steiger, MD,Prof, University Hospital Basel, Transplantation Immunology and Nephrology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

February 1, 2015

Study Completion (ACTUAL)

February 1, 2015

Study Registration Dates

First Submitted

March 12, 2009

First Submitted That Met QC Criteria

March 12, 2009

First Posted (ESTIMATE)

March 13, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 14, 2015

Last Update Submitted That Met QC Criteria

April 13, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 82/06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Transplantation, Kidney

Clinical Trials on ATG Fresenius

3
Subscribe