NCT01239563

Brief Summary

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.

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
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2011

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

November 10, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

November 11, 2010

Status Verified

November 1, 2010

Enrollment Period

1.3 years

First QC Date

November 10, 2010

Last Update Submit

November 10, 2010

Conditions

Kidney TransplantationIschemia-Reperfusion Injury

Keywords

kidney transplantationdonation after cardiac deathischemia-reperfusion injurythymoglobulinsteroid avoidancelymphocyte

Outcome Measures

Primary Outcomes (1)

  • delayed graft function

    7 days

Secondary Outcomes (2)

  • steroid avoidance

    1 year

  • lymphocyte repopulation

    1 year

Study Arms (2)

Thymoglobulin

EXPERIMENTAL

Thymoglobulin induction group

Drug: antithymocyte globulin

Basiliximab

ACTIVE COMPARATOR

Basiliximab induction - 20 mg, day 0 and day 4

Drug: Basiliximab

Interventions

antithymocyte globulinDRUG

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

Also known as: Thymoglobulin, L04AA04
Thymoglobulin
BasiliximabDRUG

Intravenous 20mg, day 0\&4

Also known as: Simulect
Basiliximab

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Oxford Transplant Centre, Churchill Hospital

Oxford, Oxfordshire, OX3 7LJ, United Kingdom

Location

University of Oxford

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Reperfusion Injury

Interventions

Antilymphocyte SerumthymoglobulinBasiliximab

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immune SeraAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsBiological ProductsComplex MixturesAntibodies, Monoclonal, HumanizedAntibodies, Monoclonal

Study Officials

  • Peter J Friend, MD FRCS

    University of Oxford

    PRINCIPAL INVESTIGATOR

  • Susan V Fuggle, DPhil MRCPath

    Oxford Radclifffe Hospitals NHS Trust

    STUDY DIRECTOR

  • Kathryn Wood, DPhil BSc

    University of Oxford

    STUDY DIRECTOR

Central Study Contacts

Anand Sivaprakash Rathnasamy Muthusamy, MBBS MRCS

CONTACT

44 1865 741841anand.muthusamy@orh.nhs.uk

Jens Brockmann, MD

CONTACT

44 1865 741841jens.brockmann@nds.ox.ac.uk

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

November 10, 2010

First Posted

November 11, 2010

Study Start

January 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2016

Last Updated

November 11, 2010

Record last verified: 2010-11

Locations

GB(2)