Trials / Unknown
UnknownNCT00733733
Anti-T-Lymphocyte Globulin (ATG) in Renal Transplantation of Kidneys With a Non-Heart-Beating (NHB) Donor
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.
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- Sponsor
- Radboud University Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2008-01-01
- Primary completion
- 2010-01-01
- Completion
- 2010-06-01
- First posted
- 2008-08-13
- Last updated
- 2008-08-13
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT00733733. Inclusion in this directory is not an endorsement.