- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00861536
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
Conditions
Intervention / Treatment
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
-
-
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Basel, Switzerland, 4031
- University Hospital Basel, Transplantation Immunology and Nephrology
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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:
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.
- 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.
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
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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
Keywords
Additional Relevant MeSH Terms
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.
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