NCT00733733

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

August 13, 2008

Status Verified

August 1, 2008

Enrollment Period

2 years

First QC Date

August 12, 2008

Last Update Submit

August 12, 2008

Conditions

Renal Transplant PatientsRecipients of a Kidney From a Non-Heart-Beating Donor

Keywords

kidneytransplantationnon-heart-beating donordelayed graft functionAntithymocyte globulinischemia-reperfusion damage

Outcome Measures

Primary Outcomes (1)

  • Incidence of initial delayed graft function (defined as need for dialysis)

    Within three months after transplantation

Secondary Outcomes (14)

  • Duration of initial delayed graft failure

    Within 3 months after transplantation

  • Incidence of primary never-functioning grafts

    Within 3 months after transplantation

  • Incidence of acute rejections (biopsy proven)

    Within 3 months after transplantation

  • Renal function as determined by MDRD

    At 1, 2, 3 months after transplantation

  • Proteinuria

    At 1, 2, 3 months after transplantation

  • +9 more secondary outcomes

Study Arms (2)

ATG

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

Standard immunosuppressive treatment for renal transplantation including tacrolimus/MMF/prednisolone without ATG treatment.

Interventions

ATG FreseniusDRUG

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)

ATG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-heart-beating-donors (Maastricht III/IV)
  • Female patients of childbearing age agree to maintain effective birth control practice during the study.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMC St Radboud Hospital

Nijmegen, 6525 GA, Netherlands

RECRUITING

MeSH Terms

Conditions

Delayed Graft Function

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • andries hoitsma, prof.dr.

    UMC St Radboud Hospital, Nijmegen, the Netherlands

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andries Hoitsma, Prof. Dr.

CONTACT

+31243614761a.hoitsma@nier.umcn.nl

Luuk Hilbrands, Dr.

CONTACT

+31243614761l.hilbrands@nier.umcn.nl

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 12, 2008

First Posted

August 13, 2008

Study Start

January 1, 2008

Primary Completion

January 1, 2010

Study Completion

June 1, 2010

Last Updated

August 13, 2008

Record last verified: 2008-08

Locations

NL(1)