Clinical trial NCT00733733: Anti-T-Lymphocyte Globulin (ATG) in Renal Transplantation of Kidneys With a Non-Heart-Beating (NHB) Donor
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Renal Transplant Patients
Recipients of a Kidney From a Non-Heart-Beating Donor
Keywords: kidney
transplantation
non-heart-beating donor
delayed graft function
Antithymocyte globulin
ischemia-reperfusion damage
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Erasmus Medical Center
name: Maastricht University
name: Leiden University Medical Center
name: UMC Utrecht
name: University Medical Center Groningen
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
First posted: 2008-08-13
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Incidence of initial delayed graft function (defined as need for dialysis)
timeFrame: Within three months after transplantation
Secondary outcomes:
measure: Duration of initial delayed graft failure
timeFrame: Within 3 months after transplantation
measure: Incidence of primary never-functioning grafts
timeFrame: Within 3 months after transplantation
measure: Incidence of acute rejections (biopsy proven)
timeFrame: Within 3 months after transplantation
measure: Renal function as determined by MDRD
timeFrame: At 1, 2, 3 months after transplantation
measure: Proteinuria
timeFrame: At 1, 2, 3 months after transplantation
measure: Percentage of patients with arterial hypertension
timeFrame: At 3 months after transplantation
measure: Percentage of patients with antihypertensive drugs (and the number of different classes of antihypertensive drugs)
timeFrame: At 3 months after transplantation
measure: Percentage of hyperlipidemic patients
timeFrame: At 3 months after transplantation
measure: Percentage of post transplant diabetes mellitus
timeFrame: During 3 months after transplantation
measure: Incidence of cytomegalovirus infection
timeFrame: During 3 months after transplantation
measure: Incidence of tumours/PTLD
timeFrame: At 3 months after transplantation
measure: Patient and graft survival
timeFrame: At 3 months after transplantation
measure: Incidence of other infections
timeFrame: During 3 months after transplantation
measure: Microalbuminuria
timeFrame: At 1, 2, 3 months after transplantation
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: UMC St Radboud Hospital
Study officials:
affiliation: UMC St Radboud Hospital, Nijmegen, the Netherlands
name: andries hoitsma, prof.dr.
role: PRINCIPAL_INVESTIGATOR
References: