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

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ClinicalTrials.gov Identifier: NCT00733733
Recruitment Status : Unknown
Verified August 2008 by Radboud University.
Recruitment status was:  Recruiting
First Posted : August 13, 2008
Last Update Posted : August 13, 2008
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Renal Transplant Patients Recipients of a Kidney From a Non-Heart-Beating Donor Drug: ATG Fresenius Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : January 2008
Estimated Primary Completion Date : January 2010
Estimated Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus
U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :
  1. Incidence of initial delayed graft function (defined as need for dialysis) [ Time Frame: Within three months after transplantation ]

Secondary Outcome Measures :
  1. Duration of initial delayed graft failure [ Time Frame: Within 3 months after transplantation ]
  2. Incidence of primary never-functioning grafts [ Time Frame: Within 3 months after transplantation ]
  3. Incidence of acute rejections (biopsy proven) [ Time Frame: Within 3 months after transplantation ]
  4. Renal function as determined by MDRD [ Time Frame: At 1, 2, 3 months after transplantation ]
  5. Proteinuria [ Time Frame: At 1, 2, 3 months after transplantation ]
  6. Percentage of patients with arterial hypertension [ Time Frame: At 3 months after transplantation ]
  7. Percentage of patients with antihypertensive drugs (and the number of different classes of antihypertensive drugs) [ Time Frame: At 3 months after transplantation ]
  8. Percentage of hyperlipidemic patients [ Time Frame: At 3 months after transplantation ]
  9. Percentage of post transplant diabetes mellitus [ Time Frame: During 3 months after transplantation ]
  10. Incidence of cytomegalovirus infection [ Time Frame: During 3 months after transplantation ]
  11. Incidence of tumours/PTLD [ Time Frame: At 3 months after transplantation ]
  12. Patient and graft survival [ Time Frame: At 3 months after transplantation ]
  13. Incidence of other infections [ Time Frame: During 3 months after transplantation ]
  14. Microalbuminuria [ Time Frame: At 1, 2, 3 months after transplantation ]

Eligibility Criteria

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

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.
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): NCT00733733

Contact: Andries Hoitsma, Prof. Dr. +31243614761 a.hoitsma@nier.umcn.nl
Contact: Luuk Hilbrands, Dr. +31243614761 l.hilbrands@nier.umcn.nl

UMC St Radboud Hospital Recruiting
Nijmegen, Netherlands, 6525 GA
Contact: andries hoitsma, prof. dr.    +31243614761    a.hoitsma@nier.umcn.nl   
Contact: Luuk Hilbrands, Dr.    +31243614761    l.hilbrands@nier.umcn.nl   
Principal Investigator: Martijn hoogen vd, drs.         
Sponsors and Collaborators
Radboud University
Erasmus Medical Center
Maastricht University
Leiden University Medical Center
UMC Utrecht
University Medical Center Groningen
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Principal Investigator: andries hoitsma, prof.dr. UMC St Radboud Hospital, Nijmegen, the Netherlands
More Information

Responsible Party: Prof. Dr. A.J. Hoitsma, UMC St Radboud Hospital
ClinicalTrials.gov Identifier: NCT00733733     History of Changes
Other Study ID Numbers: Euro-NHB
First Posted: August 13, 2008    Key Record Dates
Last Update Posted: August 13, 2008
Last Verified: August 2008

Keywords provided by Radboud University:
non-heart-beating donor
delayed graft function
Antithymocyte globulin
ischemia-reperfusion damage

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents