Kidney TransplantationPhase 4NCT01149993
Attenuating Ischemia Reperfusion Injury After Living Donor Renal Transplantation
A Phase 4 study testing Myfortic (mycophenolic acid) and Thymoglobulin (anti-thymocyte globulin) in people with Kidney Transplantation and Renal Transplantation, run by Georgetown University.
Trial summary
Patients undergoing living donor renal transplant will be asked to participate to determine whether pre-operative dosing of immunosuppressive medication, and the donor organ receiving an additional dose of antibody induction therapy helps to alleviate potential damage to the transplanted organ post-transplant. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Kidney Transplantation, Renal Transplantation, Reperfusion Injury
- What is being tested?
- Myfortic (mycophenolic acid) and Thymoglobulin (anti-thymocyte globulin)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to Jun 2012
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be able to provide written informed consent.
- All recipients of a kidney from a living donor only, either a de novo transplant, or re-transplant
- All patients evaluated and listed with the United Network for Organ Sharing (UNOS) who are eligible to receive a kidney transplant under GUH's standard protocol.
- Patients between 18-80 years of age
Who cannot join
- Recipients of multi-organ transplant
- Patients with known allergies of hypersensitivities to any of the drugs used in this protocol
- Recipients of kidneys from a deceased donor
- Recipients who are co-infected with Hepatitis B, Hepatitis C or HIV
- Women who are pregnant
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle or sexual orientation precludes intercourse with a male partner unless they agree to avoid pregnancy throughout the duration of the trial and for 3 months following the trial.
About this study
Patients undergoing living donor renal transplant will be asked to participate to determine whether pre-operative dosing of immunosuppressive medication, and the donor organ receiving an additional dose of antibody induction therapy helps to alleviate potential damage to the transplanted organ post-transplant. A number of lab tests will be done post-transplant to determine how well the kidney is functioning.
- Being tested
- Myfortic (mycophenolic acid), Thymoglobulin (anti-thymocyte globulin)
- Keywords
- living donation, kidney transplantation, delayed graft function, ischemia reperfusion injury
- Medical subject headings
- Reperfusion Injury, Delayed Graft Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myfortic (mycophenolic acid)Drug
720mg twice a day for 7 days prior to transplantation
Myfortic (mycophenolic acid)Drug
720mg twice a day after transplant
Thymoglobulin (anti-thymocyte globulin)Drug
up to 25 mg will be infused into the renal artery of a donor kidney prior to transplantation into the recipient.
Thymoglobulin (anti-thymocyte globulin)Drug
standard of care for Georgetown University Hospital: 1.5 mg/kg/day infused over 6 hours.
| Study group | Role | What they receive |
|---|---|---|
| pre-transplant immunosuppression | Experimental | subjects in this arm will receive Myfortic 720mg twice daily for 7 days prior to transplantation. Intra-operatively, the donor kidney will receive an infusion of Thymoglobulin, prior to the transplantation. Receives: Drug: Myfortic (mycophenolic acid); Drug: Thymoglobulin (anti-thymocyte globulin) |
| pre-transplant induction | Experimental | subjects in this arm will not receive any pre-transplant immunosuppression. However, the donor kidney will receive an infusion of Thymoglobulin prior to transplantation. Receives: Drug: Myfortic (mycophenolic acid); Drug: Thymoglobulin (anti-thymocyte globulin) |
| standard of care | Active comparator | subjects in this arm will not receive any pre-transplant immunosuppression, and the donor kidney will not receive an additional dose of Thymoglobulin prior to transplantation. This is the standard of care protocol for Georgetown University Hospital Receives: Drug: Myfortic (mycophenolic acid); Drug: Thymoglobulin (anti-thymocyte globulin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction in ischemia reperfusion injury
Monitor immediate graft functioning, mitochodrial membrane potential, serum creatinine, and cylex immunomonitoring to determine if pre-transplant immunosuppression, and an additional intra-operative dose of induction agent helps to reduce ischemic reperfusion injury.
Measured: one year
Secondary outcomes (1)
secondary outcomes
incidence of acute rejection, graft survival, patient survival, change in cylex values
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: FDA clinical hold, IND withdrawn.
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 Georgetown UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Keith Melancon,MD, Georgetown University
- Investigators
- Joseph K Melancon, MD, Principal investigator, Georgetown University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01149993
- Sponsor's protocol ID
- 2009-496
- Status last verified
- Jun 2014
- First submitted
- 21 Jun 2010
- Last updated
- 9 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attenuating Ischemia Reperfusion Injury After Living Donor Renal Transplantation
- ClinicalTrials.gov ID
- NCT01149993
- Acronym / sponsor ID
- 2009-496
- Keywords
- living donation, kidney transplantation, delayed graft function, ischemia reperfusion injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: FDA clinical hold, IND withdrawn.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Jun 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 24 Jun 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.
Patients undergoing living donor renal transplant will be asked to participate to determine whether pre-operative dosing of immunosuppressive medication, and the donor organ receiving an additional dose of antibody induction therapy helps to alleviate potential damage to the transplanted organ post-transplant. A number of lab tests will be done post-transplant to determine how well the kidney is functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pre-transplant immunosuppression | Experimental | Drug: Myfortic (mycophenolic acid), Drug: Thymoglobulin (anti-thymocyte globulin)subjects in this arm will receive Myfortic 720mg twice daily for 7 days prior to transplantation. Intra-operatively, the donor kidney will receive an infusion of Thymoglobulin, prior to the transplantation. |
| pre-transplant induction | Experimental | Drug: Myfortic (mycophenolic acid), Drug: Thymoglobulin (anti-thymocyte globulin)subjects in this arm will not receive any pre-transplant immunosuppression. However, the donor kidney will receive an infusion of Thymoglobulin prior to transplantation. |
| standard of care | Active comparator | Drug: Myfortic (mycophenolic acid), Drug: Thymoglobulin (anti-thymocyte globulin)subjects in this arm will not receive any pre-transplant immunosuppression, and the donor kidney will not receive an additional dose of Thymoglobulin prior to transplantation. This is the standard of care protocol for Georgetown University Hospital |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be able to provide written informed consent.
- All recipients of a kidney from a living donor only, either a de novo transplant, or re-transplant
- All patients evaluated and listed with the United Network for Organ Sharing (UNOS) who are eligible to receive a kidney transplant under GUH's standard protocol.
- Patients between 18-80 years of age
Key exclusion criteria (6 listed)
- Recipients of multi-organ transplant
- Patients with known allergies of hypersensitivities to any of the drugs used in this protocol
- Recipients of kidneys from a deceased donor
- Recipients who are co-infected with Hepatitis B, Hepatitis C or HIV
- Women who are pregnant
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 |
|---|---|---|
| Myfortic (mycophenolic acid)720mg twice a day for 7 days prior to transplantation | Drug | pre-transplant immunosuppression |
| Myfortic (mycophenolic acid)720mg twice a day after transplant | Drug | pre-transplant immunosuppression, pre-transplant induction, standard of care |
| Thymoglobulin (anti-thymocyte globulin)up to 25 mg will be infused into the renal artery of a donor kidney prior to transplantation into the recipient. | Drug | pre-transplant immunosuppression, pre-transplant induction |
| Thymoglobulin (anti-thymocyte globulin)standard of care for Georgetown University Hospital: 1.5 mg/kg/day infused over 6 hours. | Drug | pre-transplant immunosuppression, pre-transplant induction, standard of care |
Primary outcome
reduction in ischemia reperfusion injury
Time frame: one year
Monitor immediate graft functioning, mitochodrial membrane potential, serum creatinine, and cylex immunomonitoring to determine if pre-transplant immunosuppression, and an additional intra-operative dose of induction agent helps to reduce ischemic reperfusion injury.
1 secondary outcome
secondary outcomes
Time frame: one year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2014.
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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.
Joseph K Melancon, MD principal investigator
Georgetown University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Myfortic (mycophenolic acid) and Thymoglobulin (anti-thymocyte globulin) in people with Kidney Transplantation and Renal Transplantation, run by Georgetown University.
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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 9 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction in ischemia reperfusion injury (time frame: one year). 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 9 Jun 2014.