Efficacy and Safety of ATG-Fresenius Following a Renal Transplantation, Without Corticosteroids

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2011-01-31

Brief Summary

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The main objective of the study is the assessment of the overall graft rejection rate (acute, chronic and subclinical) between a treatment with ATG-Fresenius administered in addition to standard treatment consisting of CellCept® or Myfortic®/TAC and without corticosteroids and a treatment consisting of CellCept® or Myfortic®/TAC and corticosteroids during the first year after renal transplantation.

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Detailed Description

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Conditions

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Renal Transplant Rejection

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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Study Group

immunosuppressive treatment consisting of ATG-Fresenius/TAC/MMF or Myfortic

Group Type ACTIVE_COMPARATOR

ATG-Fresenius S

Intervention Type DRUG

Dosage: Single high-dose of 9 mg/kg pre-operatively, followed by 3 mg/kg/d at day +2 and +4. ATG-Fresenius treatment at Days 0, +2, and +4 is mandatory.

(In case of persisting DGF, the treatment is left to the discretion of the investigator. Treatment options include the continuation of ATG-Fresenius treatment with 3 mg/kg/d at Day +6 and if deemed necessary also at Day +8 - but without corticosteroids).

Control Group

immunosuppressive treatment consisting of TAC, MMF or Myfortic, and corticosteroids.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ATG-Fresenius S

Dosage: Single high-dose of 9 mg/kg pre-operatively, followed by 3 mg/kg/d at day +2 and +4. ATG-Fresenius treatment at Days 0, +2, and +4 is mandatory.

(In case of persisting DGF, the treatment is left to the discretion of the investigator. Treatment options include the continuation of ATG-Fresenius treatment with 3 mg/kg/d at Day +6 and if deemed necessary also at Day +8 - but without corticosteroids).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Signed and dated informed consent form,
* End-stage renal disease,
* Candidates for a first transplantation,
* Re-transplant patients are eligible if a graft loss after transplantation was NOT due to immunological reasons,
* Availability of a heart-beating cadaveric donor up to 70 years of age with a cold ischemia time shorter than 36 hours,
* Male or female patients between 18 to 75 years of age inclusive,
* Patients able to comply with all study related requirements,
* Patients able to receive oral medication,
* Women of childbearing age with a safe contraceptive method throughout the study.

Exclusion Criteria

* Women who are pregnant or breast feeding,
* Known Human Immunodeficiency Virus,
* Hepatitis B Virus or Hepatitis C Virus infection,
* Severe actual viral, bacterial or fungal infection not adequately controlled,
* Patients with anamnestically known hypersensitivity to rabbit immunoglobulin antibodies or positive rabbit immunoglobulin skin test or known allergies to any component of the immunosuppressive drugs per protocol,
* Patients at high immunological risk defined as current PRA \> 25% or historical PRA \> 50%,
* Patients receiving pre-transplant immunosuppressive treatment, including corticosteroids,
* Patients with current or history of malignancies (exception basal cell carcinoma or squamous cell carcinoma in remission),
* Patients with previous transplantation except 1st graft loss due to surgical complications,
* Patients receiving combined transplantation,
* Patients with major organ dysfunctions,
* Serious psychiatric or psychological disorders,
* Pre-transplant thrombocytopenia: \< 50,000 thrombocytes/µl, Pre-transplant leukopenia: \< 2,000 leukocytes/µl,
* Unable or unwilling to comply fully with the protocol,
* Participation in another study of an investigational medicinal product concurrently or within the last 30 days.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No