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Comparison of ATG to Thymoglobuline in Renal Transplantation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00861536
First Posted: March 13, 2009
Last Update Posted: April 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
  Purpose
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.

Condition Intervention Phase
Transplantation, Kidney Drug: ATG Fresenius Drug: Thymoglobuline Genzyme Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Adverse events [ Time Frame: Daily ]

Secondary Outcome Measures:
  • Rejection [ Time Frame: Daily ]
  • Graft function [ Time Frame: Daily ]
  • Patient survival [ Time Frame: Daily ]
  • Graft survival [ Time Frame: Daily ]

Enrollment: 40
Study Start Date: January 2009
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ATG Fresenius Drug: ATG Fresenius
Day 0: 9 mg/kg bw bolus Days 1-4: 3 mg/kg bw/d
Active Comparator: Thymoglobuline Genzyme Drug: Thymoglobuline Genzyme
Day 0-3: 1.5 mg/kg bw/d

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00861536


Locations
Switzerland
University Hospital Basel, Transplantation Immunology and Nephrology
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Juerg Steiger, MD,Prof University Hospital Basel, Transplantation Immunology and Nephrology
  More Information

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00861536     History of Changes
Other Study ID Numbers: 82/06
First Submitted: March 12, 2009
First Posted: March 13, 2009
Last Update Posted: April 14, 2015
Last Verified: April 2015

Keywords provided by University Hospital, Basel, Switzerland:
risk factors
immunology