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

Renal Transplant Patients Clinical Trial

— ATG  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00733733
• Other study ID #: Euro-NHB
• Status: Recruiting
• Phase: Phase 3
• First received: August 12, 2008
• Last updated: August 12, 2008
• Start date: January 2008
• Est. completion date: June 2010

Study information

• Verified date: August 2008
• Source: Radboud University
• Contact: Andries Hoitsma, Prof. Dr.
• Phone: +31243614761
• Email: a.hoitsma[@]nier.umcn.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: June 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Recipients of a Kidney From a Non-Heart-Beating Donor
• Renal Transplant Patients

Intervention

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)

Locations

Country	Name	City	State
Netherlands	UMC St Radboud Hospital	Nijmegen

Sponsors (7)

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

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of initial delayed graft function (defined as need for dialysis)		Within three months after transplantation	No
Secondary	Duration of initial delayed graft failure		Within 3 months after transplantation	No
Secondary	Incidence of primary never-functioning grafts		Within 3 months after transplantation	No
Secondary	Incidence of acute rejections (biopsy proven)		Within 3 months after transplantation	No
Secondary	Renal function as determined by MDRD		At 1, 2, 3 months after transplantation	No
Secondary	Proteinuria		At 1, 2, 3 months after transplantation	No
Secondary	Percentage of patients with arterial hypertension		At 3 months after transplantation	No
Secondary	Percentage of patients with antihypertensive drugs (and the number of different classes of antihypertensive drugs)		At 3 months after transplantation	No
Secondary	Percentage of hyperlipidemic patients		At 3 months after transplantation	No
Secondary	Percentage of post transplant diabetes mellitus		During 3 months after transplantation	No
Secondary	Incidence of cytomegalovirus infection		During 3 months after transplantation	No
Secondary	Incidence of tumours/PTLD		At 3 months after transplantation	Yes
Secondary	Patient and graft survival		At 3 months after transplantation	No
Secondary	Incidence of other infections		During 3 months after transplantation	Yes
Secondary	Microalbuminuria		At 1, 2, 3 months after transplantation	No