Transplanted Kidney Ischemia Reperfusion InjuryPhase 2NCT01731457
Limitation of Ischemic Injury of a Kidney Stored in Machine Perfusion in Hypothermia - Evaluation of the Impact on Kidney Allograft Function
A Phase 2 study testing etanercept in people with Transplanted Kidney Ischemia Reperfusion Injury, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The aims of this study are: 1. assessment of ischemia injury of kidney retrieved from standard and expanded criteria deceased donor before transplantation 2. assessment of efficacy of kidney ischemia injury decreasing 3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplanted Kidney Ischemia Reperfusion Injury
- What is being tested?
- etanercept
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 sitePoland
- Study dates
- Apr 2011to Feb 2016
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DONOR STAGE
- donor after brain death
- seronegative HCV (hepatitis C virus)
- procurement of two kidneys from the same donor
- donor center distance up to 220 kilometres from Warsaw
- availability of fluid KPS-1 and cartridge of Organ Recovery System
Show all 10Show fewer
- RECIPIENT STAGE
- recipient of kidneys from deceased donor
- at least eighteen recipient
- expression of informed consent
Who cannot join
- DONOR STAGE
- live kidney donor
- seropositive HCV (hepatitis C virus)
- get only one from the kidneys
- "doubtful" donor - e.g. need for biopsy because of proteinuria or due to histological lesions (e.g. tumor)
- donor center distance above 220 kilometres from Warsaw
Show all 16Show fewer
- lack of fluid KPS-1 and cartridge of Organ Recovery System
- RECIPIENT STAGE
- recipient of kidney form living donor
- minor recipient
- no expression of informed consent
- multiple organ recipient
- recipient "EN BLOC" kidneys or two kidneys
- recipient of kidney from donor under 14 years old
- a need of atypical urinary diversion in kidney recipient
- participation in another study at least in the last 30 days
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of General Surgery and Transplantation
Warsaw, Masovian Voivodeship, 02-006
About this study
The aims of this study are:
- assessment of ischemia injury of kidney retrieved from standard and expanded criteria deceased donor before transplantation
- assessment of efficacy of kidney ischemia injury decreasing
- assessment of influence of kidney ischemia injury decreasing on its function after transplantation For the purpose of this research one hundred kidney will be retrieved from deceased donors (standard and expanded criteria deceased donors) for transplantation. All kidneys before transplantation will be stored in machine perfusion in hypothermia with continuous flow - Organ Recovery Systems LifePort - each single kidney in self-contained perfusion system.
Read more
For the kidney allograft assessment will be used measurements performed during machine perfusion in hypothermia: renal flow, resistance, lactate dehydrogenase, lactates and ischemia injury markers measured in the fourth hour of perfusion in perfusion fluid.
For kidney ischemia injury assessment such markers will be measured: tumour necrosis factor (TNF alfa), interleukin 2 (IL-2), interleukin 6 (IL-6), high sensitivity C-reactive protein (hsCRP), platelet-derived growth factor (PDGF), cystatin C, kidney Injury Molecule (KIM-1), neutrophil Gelatinase-associated Lipocalin (NGAL), complement component C3, caspase 3.
Every time from pair of retrieved kidneys each kidney will be randomise for one of the group:
- group 1) - 50 kidneys - examined group - "cured" with etanercept (ENBREL) in the first hour of perfusion by adding drug to perfusion fluid,
- group 2) - 50 kidneys - control group - without intervention. Ischemia injury markers will be measured in perfusion fluid by kidney two times (in the first and fourth hour of perfusion) for assessment of efficacy kidney ischemia injury decreasing.
Results of measurements of kidney ischemia injury before transplantation, parameters during machine perfusion in hypothermia and donor parameters will be correlated with kidney allograft function post transplantation.
Immediate, delayed and slow graft function, primary non-function, kidney function assessed by creatinine concentration and creatinine clearance at one day, seven days, two weeks, 1, 6 and 12 months post transplantation and kidney graft survival 6 and 12 months post transplantation will be analysed.
- Being tested
- etanercept
- Keywords
- ischemia, reperfusion, kidney, transplantation
- Medical subject headings
- Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etanerceptDrug
adding appropriate dose of etanercept to the perfusion fluid
| Study group | Role | What they receive |
|---|---|---|
| Etanercept | Experimental | Not described Receives: Drug: etanercept |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
delayed graft function
a need at least one dialysis during first week after transplantation
Measured: one week
12 months graft survival
survival of kidney grafts 12 months after transplantation
Measured: 12 months
Secondary outcomes (2)
acute rejection
biopsy proven acute rejection episodes during the first year after transplantation
Measured: 12 months
kidney ischemia injury assessment
ischemia injury markers measured two times (in the first and fourth hour of perfusion) in perfusion fluid: tumour necrosis factor (TNF alfa), interleukin 2 (IL-2), interleukin 6 (IL-6), high sensitivity C-reactive protein (hsCRP), platelet-derived growth factor (PDGF), cystatin C, kidney Injury Molecule (KIM-1), neutrophil Gelatinase-associated Lipocalin (NGAL), complement component C3, caspase 3
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startApr 2011
- Primary completionFeb 2014
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplanted Kidney Ischemia Reperfusion InjuryStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piotr Domagała, Medical University of Warsaw
- Investigators
- Piotr Domagala, MD, PhD, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01731457
- Sponsor's protocol ID
- N N403 589338-WUM-PD-Poland
- Status last verified
- Dec 2016
- First submitted
- 15 Nov 2012
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Limitation of Ischemic Injury of a Kidney Stored in Machine Perfusion in Hypothermia - Evaluation of the Impact on Kidney Allograft Function
- ClinicalTrials.gov ID
- NCT01731457
- Acronym / sponsor ID
- N N403 589338-WUM-PD-Poland
- Keywords
- ischemia, reperfusion, kidney, transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 21 Nov 2012 (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 aims of this study are:
- assessment of ischemia injury of kidney retrieved from standard and expanded criteria deceased donor before transplantation
- assessment of efficacy of kidney ischemia injury decreasing
- assessment of influence of kidney ischemia injury decreasing on its function after transplantation For the purpose of this research one hundred kidney will be retrieved from deceased donors (standard and expanded criteria deceased donors) for transplantation. All kidneys before transplantation will be stored in machine perfusion in hypothermia with continuous flow - Organ Recovery Systems LifePort - each single kidney in self-contained perfusion system.
For the kidney allograft assessment will be used measurements performed during machine perfusion in hypothermia: renal flow, resistance, lactate dehydrogenase, lactates and ischemia injury markers measured in the fourth hour of perfusion in perfusion fluid.
For kidney ischemia injury assessment such markers will be measured: tumour necrosis factor (TNF alfa), interleukin 2 (IL-2), interleukin 6 (IL-6), high sensitivity C-reactive protein (hsCRP), platelet-derived growth factor (PDGF), cystatin C, kidney Injury Molecule (KIM-1), neutrophil Gelatinase-associated Lipocalin (NGAL), complement component C3, caspase 3.
Every time from pair of retrieved kidneys each kidney will be randomise for one of the group:
- group 1) - 50 kidneys - examined group - "cured" with etanercept (ENBREL) in the first hour of perfusion by adding drug to perfusion fluid,
- group 2) - 50 kidneys - control group - without intervention. Ischemia injury markers will be measured in perfusion fluid by kidney two times (in the first and fourth hour of perfusion) for assessment of efficacy kidney ischemia injury decreasing.
Results of measurements of kidney ischemia injury before transplantation, parameters during machine perfusion in hypothermia and donor parameters will be correlated with kidney allograft function post transplantation.
Immediate, delayed and slow graft function, primary non-function, kidney function assessed by creatinine concentration and creatinine clearance at one day, seven days, two weeks, 1, 6 and 12 months post transplantation and kidney graft survival 6 and 12 months post transplantation will be analysed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etanercept | Experimental | Drug: etanercept |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- DONOR STAGE
- donor after brain death
- seronegative HCV (hepatitis C virus)
- procurement of two kidneys from the same donor
- donor center distance up to 220 kilometres from Warsaw
Key exclusion criteria (16 listed)
- DONOR STAGE
- live kidney donor
- seropositive HCV (hepatitis C virus)
- get only one from the kidneys
- "doubtful" donor - e.g. need for biopsy because of proteinuria or due to histological lesions (e.g. tumor)
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 |
|---|---|---|
| etanerceptadding appropriate dose of etanercept to the perfusion fluid | Drug | Etanercept |
Primary outcome
delayed graft function
Time frame: one week
a need at least one dialysis during first week after transplantation
12 months graft survival
Time frame: 12 months
survival of kidney grafts 12 months after transplantation
2 secondary outcomes
acute rejection
Time frame: 12 months
kidney ischemia injury assessment
Time frame: 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
Related trials for Transplanted Kidney Ischemia Reperfusion Injury
Recruiting
The Impact of Intraoperative Diuretic Use on Delayed Graft Function Following Deceased Donor Renal Transplantation
Delayed Graft Function, Kidney Transplantation
Recruiting
Multi-parametric MRI Evaluation of Renal Graft Performance After Living Donor Donation.
Renal Insufficiency, Chronic
Not yet recruiting
Effect of Discarding Initial Reperfusion Blood on Hemodynamics, Liver Function, and 30-Day Outcomes in Liver Transplantation
Liver Transplantation, Ischaemia Reperfusion Injury
RecruitingPhase 1/2
Safety and Efficacy of Treprostinil (Remodulin®) In Reducing Ischemia-Reperfusion Injury During Kidney Transplantation
Ischemia Reperfusion Injury, Delayed Graft Function
Active, not recruitingPhase 1/2
Intravenous Estrogen in Kidney Transplant Study
Ischemia Reperfusion Injury
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.
Piotr Domagala, MD, PhD principal investigator
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing etanercept in people with Transplanted Kidney Ischemia Reperfusion Injury, run by Medical University of Warsaw at 1 site in Poland.
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 10 inclusion and 16 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: finished, as of the sponsor's last update on 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
delayed graft function (time frame: one week). The study lists 2 primary outcomes in all. 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 10 May 2017.