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Thymoglobulin Induction in Kidney Transplant Recipients

NCT ID: NCT01239563

Last Updated: 2010-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2016-05-31

Brief Summary

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The purpose of this study is to determine if anti-thymocyte globulin (Thymoglobuline) administration in the kidney transplant recipient is able to reduce the amount of damage that kidneys transplanted from deceased donors sustains on reperfusion.

Detailed Description

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The increasing disparity between organ availability and the number of patients on waiting list for a transplant has led to different strategies to improve half life of all transplants. One such method is to reduce the amount of damage the organ sustains during the period of preservation and reperfusion in the recipient. Thymoglobulin, an anti-lymphocyte antibody has been shown to have the ability to reduce this damage in experimental studies. This study aims to ascertain the role of Thymoglobulin in kidney transplants from donors after cardiac death, the type of kidney transplants at highest risk of sustaining injury during preservation. The study will involve comparison with conventional immunosuppressant therapy, comparison between Thymoglobulin administered in different doses, and observation of the patterns of blood cell repopulation (lymphocytes mainly) in the first year following kidney transplantation.

Conditions

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Kidney Transplantation Ischemia-Reperfusion Injury

Keywords

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kidney transplantation donation after cardiac death ischemia-reperfusion injury thymoglobulin steroid avoidance lymphocyte

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Thymoglobulin

Thymoglobulin induction group

Group Type EXPERIMENTAL

antithymocyte globulin

Intervention Type DRUG

Thymoglobulin 1.5mg/kg, 4 doses Thymoglobulin 6mg/kg, single dose

Basiliximab

Basiliximab induction - 20 mg, day 0 and day 4

Group Type ACTIVE_COMPARATOR

Basiliximab

Intervention Type DRUG

Intravenous 20mg, day 0\&4

Interventions

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antithymocyte globulin

Thymoglobulin 1.5mg/kg, 4 doses Thymoglobulin 6mg/kg, single dose

Intervention Type DRUG

Basiliximab

Intravenous 20mg, day 0\&4

Intervention Type DRUG

Other Intervention Names

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Thymoglobulin, L04AA04 Simulect

Eligibility Criteria

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Inclusion Criteria

* Participant is willing and able to give informed consent for participation in the study
* Male or Female, aged 18 years or above
* Recipient of DCD kidney transplant
* Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the first 12 months of the study
* Able (in the Investigators opinion) and willing to comply with all study requirements
* Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study

Exclusion Criteria

* The participant may not enter the study if ANY of the following apply:
* Failure of either recipient of a pair of kidneys to give consent
* Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
* History of specific viral infection that would contraindicate depleting antibody therapy e.g. hepatitis B\&C, HIV
* Significant hepatic impairment-.i.e. Values 3 times upper limit of normal (unless this is usual for the subject)
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study
* Participants who have participated in another research study involving an investigational product in the previous 12 weeks
* Previous administration of Thymoglobuline
* Patients with functioning non-renal transplants and on immunosuppression
* The patient is not suitable, in the opinion of the Investigator, to take part in the trial
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oxford University Hospitals NHS Trust

OTHER

Sponsor Role collaborator

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role lead

Responsible Party

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University of Oxford

Principal Investigators

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Peter J Friend, MD FRCS

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Susan V Fuggle, DPhil MRCPath

Role: STUDY_DIRECTOR

Oxford Radclifffe Hospitals NHS Trust

Kathryn Wood, DPhil BSc

Role: STUDY_DIRECTOR

University of Oxford

Locations

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Oxford Transplant Centre, Churchill Hospital

Oxford, Oxfordshire, United Kingdom

Site Status

University of Oxford

Oxford, Oxfordshire, United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Anand Sivaprakash Rathnasamy Muthusamy, MBBS MRCS

Role: CONTACT

Phone: 44 1865 741841

Email: [email protected]

Jens Brockmann, MD

Role: CONTACT

Phone: 44 1865 741841

Email: [email protected]

Facility Contacts

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Susan V Fuggle, DPhil MRCPath

Role: primary

Kathryn Wood, DPhil BSc

Role: primary

Other Identifiers

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2009-016676-73

Identifier Type: REGISTRY

Identifier Source: secondary_id

Oxford/OTC/TIKT

Identifier Type: -

Identifier Source: org_study_id