Anti-T-Lymphocyte Globulin (ATG) in Renal Transplantation of Kidneys With a Non-Heart-Beating (NHB) Donor (ATG)

August 12, 2008 updated by: Radboud University Medical Center

A Prospective, Randomized, Open, Multicenter Study to Evaluate the Efficacy and Tolerability of Induction Therapy With a Single High-Dose Anti-T-Lymphocyte Globulin (ATG) in Renal Transplant Patients With a Kidney From a Non-Heart-Beating Donor and Tacrolimus, Mycophenolate Mofetil, and Steroids as Basic Immunosuppression.

One of the greatest problems in renal transplantation is the shortage of donor kidneys. Kidneys of non-heart-beating donors (NHB) are a possible solution, but transplantation is accompanied with a high percentage of acute renal failure, caused by ischemia-reperfusion injury. The increased ischemia-reperfusion injury results in an increased immune activation, which can lead to more injury of the kidney and additional acute rejections. The hypothesis of this trial is that ischemia-reperfusion injury can be diminished by ATG. ATG could have additional favourable effects. To investigate this half of the patients is treated with additional ATG to the standard immunosuppressive treatment. Calcineurin inhibitors are not diminished during the first days after transplantation to investigate whether ATG has special effects on ischemia-reperfusion injury.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 3

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

  • Netherlands
      • Nijmegen, Netherlands, 6525 GA
        • Recruiting
        • UMC St Radboud Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Martijn hoogen vd, drs.

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:

  • Non-heart-beating-donors (Maastricht III/IV)
  • Female patients of childbearing age agree to maintain effective birth control practice during the study.

Exclusion Criteria:

  • Pregnant or lactating women at the time of randomization.
  • Patients and donors are ABO incompatible.
  • Women having had >3 pregnancies (including abortions if no consistent data on PRA or anti-donor antibodies are available).
  • Patients with hypersensibility to rabbit proteins, previous treatment with rabbit IgG, or known intolerance to any component of basal immunosuppression.
  • Patients with leukocytes <3,000/mm3 and/or platelets <50,000/mm3 before initiation of transplant.
  • Patients, who are HIV positive.
  • Patients subjected to previous transplants or candidates for multiple transplants (e.g. SKP).
  • Patients, who are unlikely to comply with the visit schedule in the protocol and patients who cannot communicate reliably with the investigator.
  • Patients with pulmonary oedema or with other signs of overhydration.

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
ACTIVE_COMPARATOR: ATG
One gift of ATG Fresenius (9 mg/kg body weight) intravenously during the transplantation procedure. ATG is given in addition to standard immunosuppressive treatment (tacrolimus/MMF/prednisolone)
Drug: ATG Fresenius
One gift of ATG Fresenius (9 mg/kg body weight) intravenously during the transplantation procedure. ATG is given in addition to standard immunosuppressive treatment (tacrolimus/MMF/prednisolone)
NO_INTERVENTION: Control
Standard immunosuppressive treatment for renal transplantation including tacrolimus/MMF/prednisolone without ATG treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of initial delayed graft function (defined as need for dialysis)
Time Frame: Within three months after transplantation
Within three months after transplantation

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of initial delayed graft failure
Time Frame: Within 3 months after transplantation
Within 3 months after transplantation
Incidence of primary never-functioning grafts
Time Frame: Within 3 months after transplantation
Within 3 months after transplantation
Incidence of acute rejections (biopsy proven)
Time Frame: Within 3 months after transplantation
Within 3 months after transplantation
Renal function as determined by MDRD
Time Frame: At 1, 2, 3 months after transplantation
At 1, 2, 3 months after transplantation
Proteinuria
Time Frame: At 1, 2, 3 months after transplantation
At 1, 2, 3 months after transplantation
Percentage of patients with arterial hypertension
Time Frame: At 3 months after transplantation
At 3 months after transplantation
Percentage of patients with antihypertensive drugs (and the number of different classes of antihypertensive drugs)
Time Frame: At 3 months after transplantation
At 3 months after transplantation
Percentage of hyperlipidemic patients
Time Frame: At 3 months after transplantation
At 3 months after transplantation
Percentage of post transplant diabetes mellitus
Time Frame: During 3 months after transplantation
During 3 months after transplantation
Incidence of cytomegalovirus infection
Time Frame: During 3 months after transplantation
During 3 months after transplantation
Incidence of tumours/PTLD
Time Frame: At 3 months after transplantation
At 3 months after transplantation
Patient and graft survival
Time Frame: At 3 months after transplantation
At 3 months after transplantation
Incidence of other infections
Time Frame: During 3 months after transplantation
During 3 months after transplantation
Microalbuminuria
Time Frame: At 1, 2, 3 months after transplantation
At 1, 2, 3 months after transplantation

Collaborators and Investigators

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

Sponsor

Radboud University Medical Center

Collaborators

University Medical Center Groningen
UMC Utrecht
Erasmus Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Leiden University Medical Center
Maastricht University

Investigators

  • Principal Investigator: andries hoitsma, prof.dr., UMC St Radboud Hospital, Nijmegen, the Netherlands

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, 2008

Primary Completion (ANTICIPATED)

January 1, 2010

Study Completion (ANTICIPATED)

June 1, 2010

Study Registration Dates

First Submitted

August 12, 2008

First Submitted That Met QC Criteria

August 12, 2008

First Posted (ESTIMATE)

August 13, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 13, 2008

Last Update Submitted That Met QC Criteria

August 12, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Euro-NHB

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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