Kidney TransplantationNCT06287008
ABO-Incompatible Kidney Transplants Between Robot-Assisted vs. Open Surgery
An observational study of Kidney Transplantation, run by Asan Medical Center at 1 site in South Korea.
Trial summary
While robot-assisted kidney transplantation (RAKT) offers potential benefits such as minimal postoperative pain, better cosmesis, fewer wound infections, and shorter hospital stay, its efficacy in ABO-incompatible (ABO-i) KT compared to open KT (OKT) remains understudied. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- robot-assisted kidney transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 239 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2020to 31 Jan 2024
- Phase
- Observational
- 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
Study population: study includes 210 patients who undergo ABOi-open kidney transplantation and 29 who undergo ABOi-robot assisted kidney transplantation
Who may be able to join
- Patient eligible for living donor ABO incompatible kidney transplantation
- Presenting an IsoAgglutinin immunoglobulin G titer (anti-A-B) between 1/8 and 1/128 before operation
- Patient older than 18 years and young than 80 years
- Patient able to sign an informed consent form
Who cannot join
- Patient with comorbidities or hypersensitivity that prevent desensitization protocols
- Women who are pregnant, or who may become pregnant or breastfeeding women
- Subjects under legal protection
- Subjects participating in another interventional research protocol or in an exclusion period from another interventional research protocolPatient affiliated with a social security scheme
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study on Outcomes of ABO-Incompatible Kidney Transplants Between Robot-Assisted vs. Open Surgery: A Retrospective Cohort Study
While robot-assisted kidney transplantation (RAKT) offers potential benefits such as minimal postoperative pain, better cosmesis, fewer wound infections, and shorter hospital stay, its efficacy in ABO-incompatible (ABO-i) KT compared to open KT (OKT) remains understudied. This study aims to compare ABO-i KT outcomes between RAKT and OKT.
The study utilized data from 29 ABO-i RAKT and 210 ABO-i OKT cases performed at Asan Medical Center from October 2020 to February 2023. Univariate and multivariate analyses were performed to evaluate factors associated with a composite of biopsy-proven acute rejection (BPAR), de novo donor-specific antibodies (DSA), and overall graft failure.
- Conditions
- Kidney Transplantation
- Being tested
- robot-assisted kidney transplantation
- Keywords
- robot-assisted kidney transplantation, ABO incompatible, biopsy-proven acute rejection, immunologically high-risk patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robot-assisted kidney transplantationProcedure or surgery
The interventional surgery is a robot-assisted kidney transplantation and its efficacy will be measured against that of open kidney transplantation
| Study group | Role | What they receive |
|---|---|---|
| OKT | patients who underwent "open kidney transplantation" | |
| RAKT | patients who underwent "robot-assisted kidney transplantation" Receives: Procedure: robot-assisted kidney transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft survival
allograft (kidney) survival
Measured: 1 year post-operative
renal function
renal function measured in terms of eGFR (Estimated Glomerular Filtration Rate)
Measured: 1 year post-operative
Secondary outcomes (1)
. A composite of biopsy-proven acute rejection, graft failure, and the development of de novo donor-specific antibodies
. A composite of biopsy-proven acute rejection, graft failure, and the development of de novo donor-specific antibodies
Measured: 1 year post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start1 Oct 2020
- Primary completion30 Sep 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sei Won Lee, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06287008
- Sponsor's protocol ID
- 2023-0085
- Status last verified
- Feb 2024
- First submitted
- 24 Feb 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kim JM, Kwon HE, Ko Y, Jung JH, Kwon H, Kim YH, Shin S. A comparative study on outcomes of ABO-incompatible kidney transplants between robot-assisted vs. open surgery-propensity score-matched analysis: a retrospective cohort study. BMC Nephrol. 2024 Nov 14;25(1):410. doi: 10.1186/s12882-024-03842-1.
PubMed 39543527
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study on Outcomes of ABO-Incompatible Kidney Transplants Between Robot-Assisted vs. Open Surgery: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06287008
- Acronym / sponsor ID
- 2023-0085
- Conditions
- Kidney Transplantation
- Keywords
- robot-assisted kidney transplantation, ABO incompatible, biopsy-proven acute rejection, immunologically high-risk patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 29 Feb 2024 (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.
While robot-assisted kidney transplantation (RAKT) offers potential benefits such as minimal postoperative pain, better cosmesis, fewer wound infections, and shorter hospital stay, its efficacy in ABO-incompatible (ABO-i) KT compared to open KT (OKT) remains understudied. This study aims to compare ABO-i KT outcomes between RAKT and OKT.
The study utilized data from 29 ABO-i RAKT and 210 ABO-i OKT cases performed at Asan Medical Center from October 2020 to February 2023. Univariate and multivariate analyses were performed to evaluate factors associated with a composite of biopsy-proven acute rejection (BPAR), de novo donor-specific antibodies (DSA), and overall graft failure.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OKT | – | –patients who underwent "open kidney transplantation" |
| RAKT | – | Procedure: robot-assisted kidney transplantationpatients who underwent "robot-assisted kidney transplantation" |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- study includes 210 patients who undergo ABOi-open kidney transplantation and 29 who undergo ABOi-robot assisted kidney transplantation
Key inclusion criteria (4 listed)
- Patient eligible for living donor ABO incompatible kidney transplantation
- Presenting an IsoAgglutinin immunoglobulin G titer (anti-A-B) between 1/8 and 1/128 before operation
- Patient older than 18 years and young than 80 years
- Patient able to sign an informed consent form
Key exclusion criteria (4 listed)
- Patient with comorbidities or hypersensitivity that prevent desensitization protocols
- Women who are pregnant, or who may become pregnant or breastfeeding women
- Subjects under legal protection
- Subjects participating in another interventional research protocol or in an exclusion period from another interventional research protocolPatient affiliated with a social security scheme
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 |
|---|---|---|
| robot-assisted kidney transplantationThe interventional surgery is a robot-assisted kidney transplantation and its efficacy will be measured against that of open kidney transplantation | Procedure or surgery | RAKT |
Primary outcome
Graft survival
Time frame: 1 year post-operative
allograft (kidney) survival
renal function
Time frame: 1 year post-operative
renal function measured in terms of eGFR (Estimated Glomerular Filtration Rate)
1 secondary outcome
. A composite of biopsy-proven acute rejection, graft failure, and the development of de novo donor-specific antibodies
Time frame: 1 year post-operative
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 1 Mar 2024.
- Derived from this study: PubMed 39543527Kim JM, Kwon HE, Ko Y, Jung JH, Kwon H, Kim YH, Shin S. A comparative study on outcomes of ABO-incompatible kidney transplants between robot-assisted vs. open surgery-propensity score-matched analysis: a retrospective cohort study. BMC Nephrol. 2024 Nov 14;25(1):410. doi: 10.1186/s12882-024-03842-1.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplantation, run by Asan Medical Center at 1 site in South Korea.
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 4 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 1 Mar 2024. 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 South Korea. 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?
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?
Graft survival (time frame: 1 year post-operative). 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 NCT06287008, which also lists 1 linked publication.
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 Mar 2024.