End-Stage Renal DiseasePhase 2NCT01756508
Eculizumab for Prevention and Treatment of Kidney Graft Reperfusion Injury
A Phase 2 study testing eculizumab in people with End-Stage Renal Disease and Kidney Failure, run by Russian Academy of Medical Sciences at 1 site in Russia.
Trial summary
Study of eculizumab ability to correct the reperfusion injury of the kidney allograft. Read more about this study
- Who is it for?
- Ages 12 months to 80 years
- Conditions the study is for
- End-Stage Renal Disease, Kidney Failure, Graft Reperfusion Injury
- What is being tested?
- eculizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteRussia
- Study dates
- 1 Sep 2012to 1 Dec 2017
- 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 12 months to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age 1-80
- weight - >6 kg
- male or female
- recipient of first kidney graft either from standard criteria deceased or live donor
- end stage renal disease or congenital nephrotic syndrome -
Who cannot join
- Blood group (ABO) incompatible transplantation
- presence of donor-specific anti-human leukocyte antigen (HLA) antibodies
- multiorgan transplantation
- previous transplant
- patients infected with HIV, hepatitis C virus (HCV) or hepatitis B virus (HBV)
- patients with haemolytic-uraemic syndrome (HUS) -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Eculizumab for Prevention and Treatment Reperfusion Injury in Kidney Transplantation.
Study of eculizumab ability to correct the reperfusion injury of the kidney allograft.
Read the detailed description
Based on experimental data and supportive observations in humans associating complement gene upregulation with ischemic reperfusion injury, it is hypothesized that C5 cleavage is a key step in the pathogenesis of ischemic reperfusion injury following transplantation. It was further hypothesized that eculizumab, antibody that blocks C5 cleavage in humans will be an effective prophylactic agent to prevent ischemic reperfusion injury in high risk recipients. For testing this hypothesis, this study is a pilot prospective study to test the efficacy of eculizumab in preventing the development of reperfusion injury and contribute graft survival.
- Being tested
- eculizumab
- Keywords
- eculizumab, kidney transplantation, reperfusion, rejection, infection
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Rejection, Psychology, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eculizumabDrug
Also called Soliris
Eculizumab 1200 mg/m2 will be administered once, 1 hour before graft reperfusion
| Study group | Role | What they receive |
|---|---|---|
| eculizumab | Experimental | Eculizumab 1200 mg/m2 will be administered once, 1 hour before graft reperfusion Receives: Drug: eculizumab |
| control | No intervention | No intervention will be applied instead eculizumab infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
speed of the graft warming
The speed of the graft surface warming in the range 15-20°C is accessed on the the infrared video record, taken during graft reperfusion by Nec Thermo Tracer.
Measured: at the time of engraftment
Secondary outcomes (3)
graft morphology changes
Protocol biopsy will be obtained at one month and one year. Progression of allograft nephropathy will be compared between groups.
Measured: one year after transplantation
One-year graft and patient survival, as well as rejection and infection rates will be calculated
Measured: one year after Tx
primary graft function
initial graft function will be accessed daily during the first week post Tx and measured as follows:
- the rate of serum creatinine decrease expressed as percent per day, where 100% will be the creatinine on the day before;
- intragraft blood flow by Doppler indexes (acceleration, resistance) and blood flow velocity on the three levels - main, interlobar and arcuate arteries;
Measured: first week after Tx
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2012 (estimated)
- Study start1 Sep 2012
- Primary completion15 Apr 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for End-Stage Renal DiseaseStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Russian Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Kaabak, Russian Academy of Medical Sciences
- Investigators
- Michael M Kaabak, MD, Principal investigator, Russian Scientific Center of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01756508
- Sponsor's protocol ID
- Eculizumab for reperfusion
- Status last verified
- Aug 2018
- First submitted
- 20 Dec 2012
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Individual participant data, except for personal data like Name, Forename, and address, will be shared by request
Publications
de Vries DK, van der Pol P, van Anken GE, van Gijlswijk DJ, Damman J, Lindeman JH, Reinders ME, Schaapherder AF, Kooten Cv. Acute but transient release of terminal complement complex after reperfusion in clinical kidney transplantation. Transplantation. 2013 Mar 27;95(6):816-20. doi: 10.1097/TP.0b013e31827e31c9.
PubMed 23348894Kaabak M, Babenko N, Shapiro R, Zokoyev A, Dymova O, Kim E. A prospective randomized, controlled trial of eculizumab to prevent ischemia-reperfusion injury in pediatric kidney transplantation. Pediatr Transplant. 2018 Mar;22(2). doi: 10.1111/petr.13129. Epub 2018 Jan 29.
PubMed 29377474
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Eculizumab for Prevention and Treatment Reperfusion Injury in Kidney Transplantation.
- ClinicalTrials.gov ID
- NCT01756508
- Acronym / sponsor ID
- Eculizumab for reperfusion
- Keywords
- eculizumab, kidney transplantation, reperfusion, rejection, infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Russian Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Sep 2012 (actual)
- Primary completion
- 15 Apr 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 27 Dec 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.
Study of eculizumab ability to correct the reperfusion injury of the kidney allograft.
Detailed description
Based on experimental data and supportive observations in humans associating complement gene upregulation with ischemic reperfusion injury, it is hypothesized that C5 cleavage is a key step in the pathogenesis of ischemic reperfusion injury following transplantation. It was further hypothesized that eculizumab, antibody that blocks C5 cleavage in humans will be an effective prophylactic agent to prevent ischemic reperfusion injury in high risk recipients. For testing this hypothesis, this study is a pilot prospective study to test the efficacy of eculizumab in preventing the development of reperfusion injury and contribute graft survival.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eculizumab | Experimental | Drug: eculizumabEculizumab 1200 mg/m2 will be administered once, 1 hour before graft reperfusion |
| control | No intervention | –No intervention will be applied instead eculizumab infusion |
Who may qualify
- Ages
- 12 months to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- age 1-80
- weight - >6 kg
- male or female
- recipient of first kidney graft either from standard criteria deceased or live donor
- end stage renal disease or congenital nephrotic syndrome -
Key exclusion criteria (6 listed)
- Blood group (ABO) incompatible transplantation
- presence of donor-specific anti-human leukocyte antigen (HLA) antibodies
- multiorgan transplantation
- previous transplant
- patients infected with HIV, hepatitis C virus (HCV) or hepatitis B virus (HBV)
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 |
|---|---|---|
| eculizumabAlso: SolirisEculizumab 1200 mg/m2 will be administered once, 1 hour before graft reperfusion | Drug | eculizumab |
Primary outcome
speed of the graft warming
Time frame: at the time of engraftment
The speed of the graft surface warming in the range 15-20°C is accessed on the the infrared video record, taken during graft reperfusion by Nec Thermo Tracer.
3 secondary outcomes
graft morphology changes
Time frame: one year after transplantation
One-year graft and patient survival, as well as rejection and infection rates will be calculated
Time frame: one year after Tx
primary graft function
Time frame: first week after Tx
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 31 Aug 2018.
- Background: PubMed 23348894de Vries DK, van der Pol P, van Anken GE, van Gijlswijk DJ, Damman J, Lindeman JH, Reinders ME, Schaapherder AF, Kooten Cv. Acute but transient release of terminal complement complex after reperfusion in clinical kidney transplantation. Transplantation. 2013 Mar 27;95(6):816-20. doi: 10.1097/TP.0b013e31827e31c9.
- Background: PubMed 29377474Kaabak M, Babenko N, Shapiro R, Zokoyev A, Dymova O, Kim E. A prospective randomized, controlled trial of eculizumab to prevent ischemia-reperfusion injury in pediatric kidney transplantation. Pediatr Transplant. 2018 Mar;22(2). doi: 10.1111/petr.13129. Epub 2018 Jan 29.
- Individual participant dataSharing planned: Yes. Individual participant data, except for personal data like Name, Forename, and address, will be shared by request
Related trials for End-Stage Renal Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
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.
Michael M Kaabak, MD principal investigator
Russian Scientific Center of Surgery
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 eculizumab in people with End-Stage Renal Disease and Kidney Failure, run by Russian Academy of Medical Sciences at 1 site in Russia.
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 5 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: finished, as of the sponsor's last update on 31 Aug 2018. 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 Russia. 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?
speed of the graft warming (time frame: at the time of engraftment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01756508, which also lists 2 linked publications.
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 31 Aug 2018.