Kidney TransplantationNCT05179434
A Study of Retrograde Reperfusion of Renal Graft to Reduce Ischemic-reperfusion Injury
A study testing Retrograde renal graft reperfusion and Conventional antegrade renal graft reperfusion (without retrograde reperfusion) in people with Kidney Transplantation and Ischemic Reperfusion Injury, run by West Kazakhstan Medical University at 1 site in Kazakhstan.
Trial summary
To evaluate whether retrograde venous reperfusion of a renal graft before antegrade arterial reperfusion can reduce ischemic-reperfusion injury. All registered eligible candidates for kidney transplant will be randomized to receive either: retrograde venous, then arterial reperfusion or antegrade arterial reperfusion. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Kidney Transplantation, Ischemic Reperfusion Injury, Reperfusion
- What is being tested?
- Retrograde renal graft reperfusion and Conventional antegrade renal graft reperfusion (without retrograde reperfusion)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteKazakhstan
- Study dates
- 1 Dec 2020to 1 Mar 2023
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with end-stage kidney disease who are ready for kidney transplantation;
- Panel reactive antibodies (PRA) less than 20%.
- informed consent to participate in the study.
Who cannot join
- recipients preparing for combined organ transplantation;
- recipients with previously performed transplantation of another organ;
- recipients preparing for transplantation with a different immunosuppressive regimen;
- upcoming blood group incompatibility (AB0-i) transplant;
- PRA antibodies more than 20%;
Trial locations and contacts
1 site in 1 country.
Kazakhstan1 site, 1 recruiting
- Recruiting
West Kazakhstan Medical University
Aktobe, 040017
Myltykbay Rysmakhanov, MD, +7 777 036 5690, mrtransplantolog@gmail.com
Aibolat Smagulov, MD, +7 778 869 6644, smagulov.aibolat@gmail.com
About this study
Official title: A Randomized Clinical Study of Retrograde Reperfusion of Renal Graft to Reduce Ischemic-Reperfusion Injury
To evaluate whether retrograde venous reperfusion of a renal graft before antegrade arterial reperfusion can reduce ischemic-reperfusion injury.
All registered eligible candidates for kidney transplant will be randomized to receive either:
- retrograde venous, then arterial reperfusion or
- antegrade arterial reperfusion.
Read the detailed description
According to our hypothesis, retrograde venous reperfusion prevents and reduces the immediate and long-term effects of renal allograft ischemic-reperfusion injury.
For the study Chi-square method of sample size estimation with a=0,05, b=0,20 required a 14 subject per group.
The study will include 30 potential kidney recipients for both group aged 18-60 years who will receive kidney transplants. Only adult patients undergoing primary living donor kidney transplantation with standard three-component immunosuppression will be enrolled to the study.The main study group will consist of 15 patients with retrograde graft reperfusion, and control group - will include 15 kidney recipients with only conventional antegrade arterial reperfusion (without retrograde reperfusion).
Patients of the study group with standard kidney implantation surgery will undergo retrograde reperfusion through the renal vein after venous anastomosis. After the venous anastomosis of the graft, an arterial anastomosis is applied with the renal artery without tightening the suture to leave a lumen sufficient for the outflow of retrograde blood. Then the retrograde blood flow through the renal vein is started, venous blood fills the graft and flows through the renal artery through the lumen of the anastomosis in a volume of 80-100 ml. Retrograde blood collected for gas and lactate analysis at the beginning of reperfusion, at the first minute and at the fifth minute. Further, the sutures of the arterial anastomosis are tightened, and after tying, a typical antegrade reperfusion of the graft through the renal artery is performed.
Patients in the control group will undergo standard kidney implantation surgery with typical antegrade arterial reperfusion.
T-test and Mann-Whitney test will be used to compare the median of urea, creatinine levels in serum and glomerular filtration rate (GFR) on the 1st, 7th, 14th, 30th, 60th postoperative day.
- Being tested
- Retrograde renal graft reperfusion, Conventional antegrade renal graft reperfusion (without retrograde reperfusion)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrograde renal graft reperfusionProcedure or surgery
Also called Venous reperfusion
Retrograde venous reperfusion of the renal graft during the kidney transplant procedure with consequent arterial reperfusion
Conventional antegrade renal graft reperfusion (without retrograde reperfusion)Procedure or surgery
Also called Arterial reperfusion
Conventional arterial antegrade renal graft reperfusion during the kidney transplant procedure
| Study group | Role | What they receive |
|---|---|---|
| Retrograde graft reperfusion | Experimental | Kidney transplantation with retrograde venous reperfusion of renal graft followed by arterial reperfusion Receives: Procedure: Retrograde renal graft reperfusion |
| conventional antegrade perfusion | Active comparator | Kidney transplantation with conventional arterial reperfusion of renal graft (without retrograde venous reperfusion) Receives: Procedure: Conventional antegrade renal graft reperfusion (without retrograde reperfusion) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal graft and recipients survival
Renal graft function quality and recipients survival
Measured: 3 months
Secondary outcomes (3)
Median serum creatinine levels
Normalization of creatinine levels in dynamics
Measured: 1 months
Median serum urea levels
Normalization of serum urea levels in dynamics
Measured: 1 months
Median glomerular filtration rate (GFR) levels
Normalization of glomerular filtration ratio (GFR) in dynamics
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start1 Dec 2020
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Mar 2023 (estimated)
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 Kidney TransplantationStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West Kazakhstan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myltykbay Rysmakhanov, West Kazakhstan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05179434
- Sponsor's protocol ID
- 116.23.11.2020
- Status last verified
- Jan 2022
- First submitted
- 16 Dec 2021
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tasoulis MK, Douzinas EE. Hypoxemic reperfusion of ischemic states: an alternative approach for the attenuation of oxidative stress mediated reperfusion injury. J Biomed Sci. 2016 Jan 19;23:7. doi: 10.1186/s12929-016-0220-0.
PubMed 26786360Molacek J, Opatrny V, Matejka R, Baxa J, Treska V. Retrograde Oxygen Persufflation of Kidney - Experiment on an Animal. In Vivo. 2016 11-12;30(6):801-805. doi: 10.21873/invivo.10997.
PubMed 27815464
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Study of Retrograde Reperfusion of Renal Graft to Reduce Ischemic-Reperfusion Injury
- ClinicalTrials.gov ID
- NCT05179434
- Acronym / sponsor ID
- 116.23.11.2020
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- West Kazakhstan Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 5 Jan 2022 (actual)
- 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.
To evaluate whether retrograde venous reperfusion of a renal graft before antegrade arterial reperfusion can reduce ischemic-reperfusion injury.
All registered eligible candidates for kidney transplant will be randomized to receive either:
- retrograde venous, then arterial reperfusion or
- antegrade arterial reperfusion.
Detailed description
According to our hypothesis, retrograde venous reperfusion prevents and reduces the immediate and long-term effects of renal allograft ischemic-reperfusion injury.
For the study Chi-square method of sample size estimation with a=0,05, b=0,20 required a 14 subject per group.
The study will include 30 potential kidney recipients for both group aged 18-60 years who will receive kidney transplants. Only adult patients undergoing primary living donor kidney transplantation with standard three-component immunosuppression will be enrolled to the study.The main study group will consist of 15 patients with retrograde graft reperfusion, and control group - will include 15 kidney recipients with only conventional antegrade arterial reperfusion (without retrograde reperfusion).
Patients of the study group with standard kidney implantation surgery will undergo retrograde reperfusion through the renal vein after venous anastomosis. After the venous anastomosis of the graft, an arterial anastomosis is applied with the renal artery without tightening the suture to leave a lumen sufficient for the outflow of retrograde blood. Then the retrograde blood flow through the renal vein is started, venous blood fills the graft and flows through the renal artery through the lumen of the anastomosis in a volume of 80-100 ml. Retrograde blood collected for gas and lactate analysis at the beginning of reperfusion, at the first minute and at the fifth minute. Further, the sutures of the arterial anastomosis are tightened, and after tying, a typical antegrade reperfusion of the graft through the renal artery is performed.
Patients in the control group will undergo standard kidney implantation surgery with typical antegrade arterial reperfusion.
T-test and Mann-Whitney test will be used to compare the median of urea, creatinine levels in serum and glomerular filtration rate (GFR) on the 1st, 7th, 14th, 30th, 60th postoperative day.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrograde graft reperfusion | Experimental | Procedure: Retrograde renal graft reperfusionKidney transplantation with retrograde venous reperfusion of renal graft followed by arterial reperfusion |
| conventional antegrade perfusion | Active comparator | Procedure: Conventional antegrade renal graft reperfusion (without retrograde reperfusion)Kidney transplantation with conventional arterial reperfusion of renal graft (without retrograde venous reperfusion) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients with end-stage kidney disease who are ready for kidney transplantation;
- Panel reactive antibodies (PRA) less than 20%.
- informed consent to participate in the study.
Key exclusion criteria (5 listed)
- recipients preparing for combined organ transplantation;
- recipients with previously performed transplantation of another organ;
- recipients preparing for transplantation with a different immunosuppressive regimen;
- upcoming blood group incompatibility (AB0-i) transplant;
- PRA antibodies more than 20%;
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 |
|---|---|---|
| Retrograde renal graft reperfusionAlso: Venous reperfusionRetrograde venous reperfusion of the renal graft during the kidney transplant procedure with consequent arterial reperfusion | Procedure or surgery | Retrograde graft reperfusion |
| Conventional antegrade renal graft reperfusion (without retrograde reperfusion)Also: Arterial reperfusionConventional arterial antegrade renal graft reperfusion during the kidney transplant procedure | Procedure or surgery | conventional antegrade perfusion |
Primary outcome
Renal graft and recipients survival
Time frame: 3 months
Renal graft function quality and recipients survival
3 secondary outcomes
Median serum creatinine levels
Time frame: 1 months
Median serum urea levels
Time frame: 1 months
Median glomerular filtration rate (GFR) levels
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Background: PubMed 26786360Tasoulis MK, Douzinas EE. Hypoxemic reperfusion of ischemic states: an alternative approach for the attenuation of oxidative stress mediated reperfusion injury. J Biomed Sci. 2016 Jan 19;23:7. doi: 10.1186/s12929-016-0220-0.
- Background: PubMed 27815464Molacek J, Opatrny V, Matejka R, Baxa J, Treska V. Retrograde Oxygen Persufflation of Kidney - Experiment on an Animal. In Vivo. 2016 11-12;30(6):801-805. doi: 10.21873/invivo.10997.
- Individual participant dataSharing planned: No
Related trials for Kidney Transplantation
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retrograde renal graft reperfusion and Conventional antegrade renal graft reperfusion (without retrograde reperfusion) in people with Kidney Transplantation and Ischemic Reperfusion Injury, run by West Kazakhstan Medical University at 1 site in Kazakhstan.
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 3 inclusion and 5 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 24 Jan 2022. 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 Kazakhstan. 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.
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 Myltykbay Rysmakhanov (+7 777 036 5690, mrtransplantolog@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal graft and recipients survival (time frame: 3 months). 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 NCT05179434, 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 24 Jan 2022.