Comparison of ATG to Thymoglobuline in Renal Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2015-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Transplantation, Kidney

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ATG Fresenius

Group Type EXPERIMENTAL

ATG Fresenius

Intervention Type DRUG

Day 0: 9 mg/kg bw bolus Days 1-4: 3 mg/kg bw/d

Thymoglobuline Genzyme

Group Type ACTIVE_COMPARATOR

Thymoglobuline Genzyme

Intervention Type DRUG

Day 0-3: 1.5 mg/kg bw/d

Interventions

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ATG Fresenius

Day 0: 9 mg/kg bw bolus Days 1-4: 3 mg/kg bw/d

Intervention Type DRUG

Thymoglobuline Genzyme

Day 0-3: 1.5 mg/kg bw/d

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No