Kidney TransplantationI/RNCT02644915
Edaravone on the Ischemia-Reperfusion(I/R) Injury in Kidney Transplantation Patients
A study testing Edaravone and 0.9%%NaCl solution in people with Kidney Transplantation, run by Xijing Hospital.
Trial summary
Ischemia-reperfusion (I/R) injury is a prominent cause of delayed graft function(DGF) after kidney transplantation. Reactive oxygen species play a crucial role in I/R injury. Edaravone is a synthetic radical scavenger that has been used in acute stroke. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Edaravone and 0.9%%NaCl solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Oct 2016
- Phase
- Interventional
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASAⅡ-Ⅲ,elective operation patients with end-stage renal disease
- Age 18yrs-55yrs for donors and the recipients
- patients under hemodialysis
- no other severe complications history for the donors and recipients
- the first kidney transplant recipients
- patients with written informed consent
Who cannot join
- ASA Ⅳ
- a second renal transplant,a multiorgan transplant or a dual kidney transplant
- having severe comorbidity history,for example,severe cardiac dysfunction
- cold ischemia time>24h or warm ischemia time>45min
- variation of blood vessel ，operation time more than 2 hours
- bleeding volume in operation>500ml and need for blood transfusion
- participate in the other clinical trial 3 months before the enrollment
- no suitable to participate in this experiment
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Edaravone on the Ischemia-Reperfusion(I/R) Injury in Kidney Transplantation Patients: A Single-Center, Double-Blinded, Randomised Controlled Trial
Ischemia-reperfusion (I/R) injury is a prominent cause of delayed graft function(DGF) after kidney transplantation. Reactive oxygen species play a crucial role in I/R injury. Edaravone is a synthetic radical scavenger that has been used in acute stroke. Some animal experiments have revealed its beneficial effects against I/R injury, our goal is therefore to investigate the effectiveness of a recipient pretreatment with Edaravone at reducing the occurrence of DGF after kidney transplantation.
Read the detailed description
Participants will be randomly assigned, in a 1:1 ratio, to receive Edaravone or control (0.9 %Sodium Chloride Solution,0.9%NaCl). The randomization sequence will be computer-generated, and randomization will be performed in blocks and will be stratified according to participating center.Edaravone and 0.9 %NaCl solution will be treated at 10 minutes before kidney reperfusion, ending in 30 minutes. The number of dialysis and the serum creatinine level within the first week after the transplantation will be recorded. The participation of each patient is scheduled for 1 month.
- Conditions
- Kidney Transplantation
- Being tested
- Edaravone, 0.9%%NaCl solution
- Keywords
- ischemia-reperfusion(I/R) injury, Edaravone
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EdaravoneDrug
Also called Edaravone Injection
Edaravone 30mg dissolved in 0.9%NaCl 100ml will be treated at 10 minutes before kidney reperfusion , ending in 30 minutes.The number of dialysis and the serum creatinine level within the first week after the transplantation will be recorded.The participation of each patient is scheduled for 1 month.
0.9%%NaCl solutionDrug
Also called normal saline
100ml 0.9%%NaCl solution,but without edaravone ,will be treated at 10 minutes before kidney reperfusion , ending in 30 minutes.
Standard anaesthesia and standard cure are given for all patients. During the operation we maintain the target blood pressure by keeping Central Venous Pressure(CVP)> 6 mmHg
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Edaravone 30mg dissolved in 0.9%NaCl 100ml will be treated at 10 minutes before kidney reperfusion, ending in 30 minutes.
Standard anaesthesia and standard cure are given for all patients. During the operation we maintain the target blood pressure by keeping Central Venous Pressure(CVP)> 6 mmHg. Receives: Drug: Edaravone |
| control group | Placebo comparator | 100ml 0.9%%NaCl solution,but without edaravone, will be treated at 10 minutes before kidney reperfusion, ending in 30 minutes.
Standard anaesthesia and standard cure are given for all patients. During the operation we maintain the target blood pressure by keeping Central Venous Pressure(CVP)> 6 mmHg. Receives: Drug: 0.9%%NaCl solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of DGF(postoperative complication after kidney transplantation)（%）
Measured: in the first week after the kidney transplantation
serum creatinine value (umoI/L)
Measured: within the first week
Secondary outcomes (6)
average daily urinary volume（ml）
Measured: within the first week
Hospital stays after operation(d)
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
graft survival
Measured: within 30 days after surgery
other postoperative complication:acute rejection episodes、thrombosis、infections
Measured: within 30 days after surgery
Content of Malondialdehyde（mol/m l）in the blood
Measured: before transplantation and 1, 2, 3 days after transplantation
Content of Superoxide dismutase（U /m l) in the blood
Measured: before transplantation and 1, 2, 3 days after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital Xi'an Jiaotong University
- Responsible party
- Principal investigator, wangqiang, Xijing Hospital
- Investigators
- Qiang Wang, Study chair, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02644915
- Sponsor's protocol ID
- zxy
- Acronym
- I/R
- Status last verified
- Dec 2015
- First submitted
- 10 Dec 2015
- Last updated
- 1 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhang L, Wang F, Wang L, Wang W, Liu B, Liu J, Chen M, He Q, Liao Y, Yu X, Chen N, Zhang JE, Hu Z, Liu F, Hong D, Ma L, Liu H, Zhou X, Chen J, Pan L, Chen W, Wang W, Li X, Wang H. Prevalence of chronic kidney disease in China: a cross-sectional survey. Lancet. 2012 Mar 3;379(9818):815-22. doi: 10.1016/S0140-6736(12)60033-6.
PubMed 22386035Shah VR, Butala BP, Parikh GP, Vora KS, Parikh BK, Modi MP, Bhosale GP, Mehta T. Combined epidural and general anesthesia for paediatric renal transplantation-a single center experience. Transplant Proc. 2008 Dec;40(10):3451-4. doi: 10.1016/j.transproceed.2008.06.065.
PubMed 19100411Kontodimopoulos N, Niakas D. Overcoming inherent problems of preference-based techniques for measuring health benefits: an empirical study in the context of kidney transplantation. BMC Health Serv Res. 2006 Jan 14;6:3. doi: 10.1186/1472-6963-6-3.
PubMed 16412242Ibrahim S, Jacobs F, Zukin Y, Enriquez D, Holt D, Baldwin W 3rd, Sanfilippo F, Ratner LE. Immunohistochemical manifestations of unilateral kidney ischemia. Clin Transplant. 1996 Dec;10(6 Pt 2):646-52.
PubMed 8996759Ojo AO, Wolfe RA, Held PJ, Port FK, Schmouder RL. Delayed graft function: risk factors and implications for renal allograft survival. Transplantation. 1997 Apr 15;63(7):968-74. doi: 10.1097/00007890-199704150-00011.
PubMed 9112349Perico N, Cattaneo D, Sayegh MH, Remuzzi G. Delayed graft function in kidney transplantation. Lancet. 2004 Nov 13-19;364(9447):1814-27. doi: 10.1016/S0140-6736(04)17406-0.
PubMed 15541456
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Edaravone on the Ischemia-Reperfusion(I/R) Injury in Kidney Transplantation Patients: A Single-Center, Double-Blinded, Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02644915
- Acronym / sponsor ID
- I/R / zxy
- Conditions
- Kidney Transplantation
- Keywords
- ischemia-reperfusion(I/R) injury, Edaravone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital Xi'an Jiaotong University
- Study start
- Mar 2016
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 1 Jan 2016 (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.
Ischemia-reperfusion (I/R) injury is a prominent cause of delayed graft function(DGF) after kidney transplantation. Reactive oxygen species play a crucial role in I/R injury. Edaravone is a synthetic radical scavenger that has been used in acute stroke. Some animal experiments have revealed its beneficial effects against I/R injury, our goal is therefore to investigate the effectiveness of a recipient pretreatment with Edaravone at reducing the occurrence of DGF after kidney transplantation.
Detailed description
Participants will be randomly assigned, in a 1:1 ratio, to receive Edaravone or control (0.9 %Sodium Chloride Solution,0.9%NaCl). The randomization sequence will be computer-generated, and randomization will be performed in blocks and will be stratified according to participating center.Edaravone and 0.9 %NaCl solution will be treated at 10 minutes before kidney reperfusion, ending in 30 minutes. The number of dialysis and the serum creatinine level within the first week after the transplantation will be recorded. The participation of each patient is scheduled for 1 month.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Drug: EdaravoneEdaravone 30mg dissolved in 0.9%NaCl 100ml will be treated at 10 minutes before kidney reperfusion, ending in 30 minutes. Standard anaesthesia and standard cure are given for all patients. During the operation we maintain the target blood pressure by keeping Central Venous Pressure(CVP)> 6 mmHg. |
| control group | Placebo comparator | Drug: 0.9%%NaCl solution100ml 0.9%%NaCl solution,but without edaravone, will be treated at 10 minutes before kidney reperfusion, ending in 30 minutes. Standard anaesthesia and standard cure are given for all patients. During the operation we maintain the target blood pressure by keeping Central Venous Pressure(CVP)> 6 mmHg. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- ASAⅡ-Ⅲ,elective operation patients with end-stage renal disease
- Age 18yrs-55yrs for donors and the recipients
- patients under hemodialysis
- no other severe complications history for the donors and recipients
- the first kidney transplant recipients
Key exclusion criteria (8 listed)
- ASA Ⅳ
- a second renal transplant,a multiorgan transplant or a dual kidney transplant
- having severe comorbidity history,for example,severe cardiac dysfunction
- cold ischemia time>24h or warm ischemia time>45min
- variation of blood vessel ，operation time more than 2 hours
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 |
|---|---|---|
| EdaravoneAlso: Edaravone InjectionEdaravone 30mg dissolved in 0.9%NaCl 100ml will be treated at 10 minutes before kidney reperfusion , ending in 30 minutes.The number of dialysis and the serum creatinine level within the first week after the transplantation will be recorded.The participation of each patient is scheduled for 1 month. | Drug | study group |
| 0.9%%NaCl solutionAlso: normal saline100ml 0.9%%NaCl solution,but without edaravone ,will be treated at 10 minutes before kidney reperfusion , ending in 30 minutes. Standard anaesthesia and standard cure are given for all patients. During the operation we maintain the target blood pressure by keeping Central Venous Pressure(CVP)> 6 mmHg | Drug | control group |
Primary outcome
Incidence of DGF(postoperative complication after kidney transplantation)（%）
Time frame: in the first week after the kidney transplantation
serum creatinine value (umoI/L)
Time frame: within the first week
6 secondary outcomes
average daily urinary volume（ml）
Time frame: within the first week
Hospital stays after operation(d)
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
graft survival
Time frame: within 30 days after surgery
other postoperative complication:acute rejection episodes、thrombosis、infections
Time frame: within 30 days after surgery
Content of Malondialdehyde（mol/m l）in the blood
Time frame: before transplantation and 1, 2, 3 days after transplantation
Content of Superoxide dismutase（U /m l) in the blood
Time frame: before transplantation and 1, 2, 3 days after transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2016.
- Background: PubMed 22386035Zhang L, Wang F, Wang L, Wang W, Liu B, Liu J, Chen M, He Q, Liao Y, Yu X, Chen N, Zhang JE, Hu Z, Liu F, Hong D, Ma L, Liu H, Zhou X, Chen J, Pan L, Chen W, Wang W, Li X, Wang H. Prevalence of chronic kidney disease in China: a cross-sectional survey. Lancet. 2012 Mar 3;379(9818):815-22. doi: 10.1016/S0140-6736(12)60033-6.
- Background: PubMed 19100411Shah VR, Butala BP, Parikh GP, Vora KS, Parikh BK, Modi MP, Bhosale GP, Mehta T. Combined epidural and general anesthesia for paediatric renal transplantation-a single center experience. Transplant Proc. 2008 Dec;40(10):3451-4. doi: 10.1016/j.transproceed.2008.06.065.
- Background: PubMed 16412242Kontodimopoulos N, Niakas D. Overcoming inherent problems of preference-based techniques for measuring health benefits: an empirical study in the context of kidney transplantation. BMC Health Serv Res. 2006 Jan 14;6:3. doi: 10.1186/1472-6963-6-3.
- Background: PubMed 8996759Ibrahim S, Jacobs F, Zukin Y, Enriquez D, Holt D, Baldwin W 3rd, Sanfilippo F, Ratner LE. Immunohistochemical manifestations of unilateral kidney ischemia. Clin Transplant. 1996 Dec;10(6 Pt 2):646-52.
- Background: PubMed 9112349Ojo AO, Wolfe RA, Held PJ, Port FK, Schmouder RL. Delayed graft function: risk factors and implications for renal allograft survival. Transplantation. 1997 Apr 15;63(7):968-74. doi: 10.1097/00007890-199704150-00011.
- Background: PubMed 15541456Perico N, Cattaneo D, Sayegh MH, Remuzzi G. Delayed graft function in kidney transplantation. Lancet. 2004 Nov 13-19;364(9447):1814-27. doi: 10.1016/S0140-6736(04)17406-0.
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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.
Qiang Wang study chair
Xijing Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Edaravone and 0.9%%NaCl solution in people with Kidney Transplantation, run by Xijing Hospital.
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 8 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 1 Jan 2016. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Xiao-ying Zhao (13513616985, zhaoxy06@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of DGF(postoperative complication after kidney transplantation)（%） (time frame: in the first week after the kidney transplantation). 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?
On the ClinicalTrials.gov record for NCT02644915, which also lists 6 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 1 Jan 2016.