Anti-T-Lymphocyte Globulin (ATG) in Renal Transplantation... | NCT00733733

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

NCT00733733

Sponsor

Radboud University Medical Center

Status

Unknown status

Last Update Posted

Aug 13, 2008Estimated

Enrollment

180Estimated

Phase

Phase 3

Conditions

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

Interventions

ATG Fresenius

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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.

Status Module

Record Verification Date

Aug 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Jan 2010Estimated

Completion Date

Jun 2010Estimated

First Submitted Date

Aug 12, 2008

First Submission Date that Met QC Criteria

Aug 12, 2008

First Posted Date

Aug 13, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 12, 2008

Last Update Posted Date

Aug 13, 2008Estimated

Name	Class
Erasmus Medical Center	OTHER
Maastricht University	OTHER
Leiden University Medical Center	OTHER
UMC Utrecht

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
ATG Fresenius	Drug	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)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of initial delayed graft function (defined as need for dialysis)		Within three months after transplantation

Secondary Outcomes

Measure	Description	Time Frame
Duration of initial delayed graft failure		Within 3 months after transplantation
Incidence of primary never-functioning grafts		Within 3 months after transplantation

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andries Hoitsma, Prof. Dr.	Contact	+31243614761		a.hoitsma@nier.umcn.nl
Luuk Hilbrands, Dr.	Contact	+31243614761		l.hilbrands@nier.umcn.nl

Overall Officials

Name	Affiliation	Role
andries hoitsma, prof.dr.	UMC St Radboud Hospital, Nijmegen, the Netherlands	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UMC St Radboud Hospital	Recruiting	Nijmegen		6525 GA	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D051799	Delayed Graft Function

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

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