Kidney TransplantationPhase 3TIKTNCT01239563
Thymoglobulin Induction in Kidney Transplant Recipients
A Phase 3 study testing antithymocyte globulin and Basiliximab in people with Kidney Transplantation and Ischemia-Reperfusion Injury, run by University of Oxford at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Transplantation, Ischemia-Reperfusion Injury
- What is being tested?
- antithymocyte globulin and Basiliximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jan 2011to May 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Oxford Transplant Centre, Churchill Hospital
Oxford, Oxfordshire, OX3 7LJ
Susan V Fuggle, DPhil MRCPath, 44 1864 226162, susan.fuggle@nds.ox.ac.uk
University of Oxford
Oxford, Oxfordshire, OX3 9DU
Kathryn Wood, DPhil BSc
Peter J Friend, MD FRCS
About this study
Official title: THYMOGLOBULIN INDUCTION AND STEROID-FREE IMMUNOSUPPRESSION IN KIDNEY TRANSPLANTATION FROM DECEASED DONORS AFTER CARDIAC DEATH-AN OPEN LABEL RANDOMISED CONTROLLED TRIAL TO EVALUATE THE ROLE OF THYMOGLOBULIN AS INDUCTION IMMUNOSUPPRESSION IN KIDNEY TRANSPLANTS FROM DECEASED DONORS AFTER CARDIAC DEATH
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.
Read the detailed description
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.
- Being tested
- antithymocyte globulin, Basiliximab
- Keywords
- kidney transplantation, donation after cardiac death, ischemia-reperfusion injury, thymoglobulin, steroid avoidance, lymphocyte
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antithymocyte globulinDrug
Also called Thymoglobulin, L04AA04
Thymoglobulin 1.5mg/kg, 4 doses Thymoglobulin 6mg/kg, single dose
BasiliximabDrug
Also called Simulect
Intravenous 20mg, day 0\&4
| Study group | Role | What they receive |
|---|---|---|
| Thymoglobulin | Experimental | Thymoglobulin induction group Receives: Drug: antithymocyte globulin |
| Basiliximab | Active comparator | Basiliximab induction - 20 mg, day 0 and day 4 Receives: Drug: Basiliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
delayed graft function
Measured: 7 days
Secondary outcomes (2)
steroid avoidance
Measured: 1 year
lymphocyte repopulation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
- Study startJan 2011
- Primary completionMay 2012 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust, Genzyme, a Sanofi Company
- Investigators
- Peter J Friend, MD FRCS, Principal investigator, University of OxfordSusan V Fuggle, DPhil MRCPath, Study director, Oxford Radclifffe Hospitals NHS TrustKathryn Wood, DPhil BSc, Study director, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01239563
- Sponsor's protocol ID
- Oxford/OTC/TIKT
- Other IDs
- 2009-016676-73, 2009
- Acronym
- TIKT
- Status last verified
- Nov 2010
- First submitted
- 10 Nov 2010
- Last updated
- 11 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THYMOGLOBULIN INDUCTION AND STEROID-FREE IMMUNOSUPPRESSION IN KIDNEY TRANSPLANTATION FROM DECEASED DONORS AFTER CARDIAC DEATH-AN OPEN LABEL RANDOMISED CONTROLLED TRIAL TO EVALUATE THE ROLE OF THYMOGLOBULIN AS INDUCTION IMMUNOSUPPRESSION IN KIDNEY TRANSPLANTS FROM DECEASED DONORS AFTER CARDIAC DEATH
- ClinicalTrials.gov ID
- NCT01239563
- Acronym / sponsor ID
- TIKT / Oxford/OTC/TIKT
- Keywords
- kidney transplantation, donation after cardiac death, ischemia-reperfusion injury, thymoglobulin, steroid avoidance, lymphocyte
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust, Genzyme, a Sanofi Company
- Study start
- Jan 2011
- Primary completion
- May 2012 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 11 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thymoglobulin | Experimental | Drug: antithymocyte globulinThymoglobulin induction group |
| Basiliximab | Active comparator | Drug: BasiliximabBasiliximab induction - 20 mg, day 0 and day 4 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antithymocyte globulinAlso: Thymoglobulin, L04AA04Thymoglobulin 1.5mg/kg, 4 doses Thymoglobulin 6mg/kg, single dose | Drug | Thymoglobulin |
| BasiliximabAlso: SimulectIntravenous 20mg, day 0\&4 | Drug | Basiliximab |
Primary outcome
delayed graft function
Time frame: 7 days
2 secondary outcomes
steroid avoidance
Time frame: 1 year
lymphocyte repopulation
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter J Friend, MD FRCS principal investigator
University of Oxford
Susan V Fuggle, DPhil MRCPath study director
Oxford Radclifffe Hospitals NHS Trust
Kathryn Wood, DPhil BSc study director
University of Oxford
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing antithymocyte globulin and Basiliximab in people with Kidney Transplantation and Ischemia-Reperfusion Injury, run by University of Oxford at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anand Sivaprakash Rathnasamy Muthusamy, MBBS MRCS (44 1865 741841, anand.muthusamy@orh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
delayed graft function (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2010.