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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Radboud University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Erasmus Medical Center
Maastricht University
Leiden University Medical Center
UMC Utrecht
University Medical Centre Groningen
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00733733
First received: August 12, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

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

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Incidence of initial delayed graft function (defined as need for dialysis) [ Time Frame: Within three months after transplantation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of initial delayed graft failure [ Time Frame: Within 3 months after transplantation ] [ Designated as safety issue: No ]
  • Incidence of primary never-functioning grafts [ Time Frame: Within 3 months after transplantation ] [ Designated as safety issue: No ]
  • Incidence of acute rejections (biopsy proven) [ Time Frame: Within 3 months after transplantation ] [ Designated as safety issue: No ]
  • Renal function as determined by MDRD [ Time Frame: At 1, 2, 3 months after transplantation ] [ Designated as safety issue: No ]
  • Proteinuria [ Time Frame: At 1, 2, 3 months after transplantation ] [ Designated as safety issue: No ]
  • Percentage of patients with arterial hypertension [ Time Frame: At 3 months after transplantation ] [ Designated as safety issue: No ]
  • Percentage of patients with antihypertensive drugs (and the number of different classes of antihypertensive drugs) [ Time Frame: At 3 months after transplantation ] [ Designated as safety issue: No ]
  • Percentage of hyperlipidemic patients [ Time Frame: At 3 months after transplantation ] [ Designated as safety issue: No ]
  • Percentage of post transplant diabetes mellitus [ Time Frame: During 3 months after transplantation ] [ Designated as safety issue: No ]
  • Incidence of cytomegalovirus infection [ Time Frame: During 3 months after transplantation ] [ Designated as safety issue: No ]
  • Incidence of tumours/PTLD [ Time Frame: At 3 months after transplantation ] [ Designated as safety issue: Yes ]
  • Patient and graft survival [ Time Frame: At 3 months after transplantation ] [ Designated as safety issue: No ]
  • Incidence of other infections [ Time Frame: During 3 months after transplantation ] [ Designated as safety issue: Yes ]
  • Microalbuminuria [ Time Frame: At 1, 2, 3 months after transplantation ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: January 2008
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00733733

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

Locations
Netherlands
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 Centre Groningen
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
Principal Investigator: andries hoitsma, prof.dr. UMC St Radboud Hospital, Nijmegen, the Netherlands
  More Information

No publications provided

Responsible Party: Prof. Dr. A.J. Hoitsma, UMC St Radboud Hospital
ClinicalTrials.gov Identifier: NCT00733733     History of Changes
Other Study ID Numbers: Euro-NHB
Study First Received: August 12, 2008
Last Updated: August 12, 2008
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

Additional relevant MeSH terms:
Immunosuppressive Agents
Tacrolimus
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013