End Stage Renal DiseaseORAKTxNCT05730257
Study Investigating Whether Robot-assisted Surgery Can Reduce Surgical Complications Following Kidney Transplantation
A study testing Robot-Assisted Kidney Transplantation and Open Kidney Transplantation in people with End Stage Renal Disease and Kidney Transplant; Complications, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial summary
The purpose of this study is to explore whether robot-assisted surgery can reduce 30-day surgical complications compared to open surgery in kidney transplantation. Participants are adult recipients of kidney transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Kidney Transplant; Complications
- What is being tested?
- Robot-Assisted Kidney Transplantation and Open Kidney Transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 2 sitesDenmark
- Study dates
- 8 May 2023to 26 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adult recipients for renal transplantation
- Both patients in dialysis as well as pre-emptive
- For recipients of kidney grafts from deceased donors, inclusion depends on the availabilty of the robotic platform and dedicated surgical team
Who cannot join
- High degree of calcification of the iliac vessels on the level of external iliac artery defined as occurrence of longitudinal plaques on non-contrast CT-scan or other relevant radiological imaging in recipient prior to transplantation
- Highly complex vascular anatomy in the donor kidney requiring multiple anastomoses as evaluated by surgeon
- Previous kidney transplantation with later allograft nephrectomy as evaluated by the surgeon preoperatively
- Patients whose abdominal anatomy may prohibit access to and placement of graft in the iliac fossa as evaluated by the surgeon preoperatively (i.e. previous laparotomy, rectal surgery, herniotomy, current multiple kidney cysts)
- Simultaneous multiple organ transplant
- Severe comorbidities contraindicating robot-assisted surgery
- Patients who are unable to understand relevant medical information and the implications of treatment alternatives and to make an independent, voluntary decision
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Urological Research Unit, Rigshospitalet
Copenhagen, N, 2200
Department of Nephrology, Rigshospitalet
Copenhagen, Ø, 2100
About this study
Official title: Open-label Randomized Clinical Trial Investigating Whether Robot-Assisted Kidney Transplantation Can Reduce Surgical Complications Compared to Open Kidney Transplantation; The ORAKTx Trial
The purpose of this study is to explore whether robot-assisted surgery can reduce 30-day surgical complications compared to open surgery in kidney transplantation.
Participants are adult recipients of kidney transplantation. Upon entry into the trial participants will be randomly assigned eiher open kidney transplantation or robot-assisted kidney transplantation. The participants in both groups will be treated in accordance with up-to-date guidelines and care.
Our hypothesis is that robot-assisted surgery can reduce vascular complications by 15% and/or major surgical complicatons by 20% within 30 days of kidney transplantation compared to open surgery.
Read the detailed description
Kidney transplantation is the ultimate surgical treatment for end stage renal disease, and while medical transplantation therapy has developed tremendously and now allows for transplantation and long-term survival, even in seemingly incompatible donors and recipients, kidney graft survival still, to a large extent, depends on a smooth and complication-free surgical procedure. In the past decade surgical techniques have been expanded by the introduction of surgical robots to improve minimally invasive surgery and optimize post-surgical care. Previous studies suggest that robot-assisted surgery has the potential to reduce complications such as surgical site infection and blood-loss, facilitate fast-track or even ambulatory surgery for complicated procedures and recent studies suggest this may be the case for kidney transplantation too.
The aim of this trial is therefore to explore if robot-assisted surgery can reduce surgical complications following kidney transplantation compared to open surgery (standard of care) and investigate the patient trajectory following the two procedures in terms of late complications, graft function and mortality. The study design is a superiority, open-label randomized clinical trial to be conducted at Rigshospitalet, the largest transplantation centre in Denmark.
The primary outcomes consist of 1) reduction in vascular complications (graft arterial stenosis, bleeding requiring reoperation, symptomatic haematomas, renal vascular thrombosis). The rate of vascular complications is currently 17.3%. With a power set at 80% and a significance level set at 5% we hypothesize that Robot-Assisted Kidney Transplantation (RAKT) can reduce vascular complications by 15% within 30 days after transplantation compared to Open Kidney Transplantation (OKT). 2) Reduction in surgical complications Clavien-Dindo > grade 2. The rate of Clavien-Dindo >2 is currently 22.8%.
With a power set at 80% and a significance level set at 5%, we hypothesize that RAKT can reduce Clavien-Dindo >2 by 20% within 30 days after transplantation compared to OKT.
The study will randomize 106 participants with an anticipated drop-out of 10% (n=96). Immediate follow-up will be 30-days after kidney transplantation to observe occurrence of primary endpoints assessed by chart review including both in- and out-patient information. Follow-up through chart review will persist for 2 years in order to monitor long-term complications and assess secondary outcomes. Participants will be randomized with a 1:1 allocation ratio using the randomization module in REDCap with differing block sizes. Dropouts will be replaced by the same randomization number to ensure equal distribution.
The study is analysed as intention-to-treat. The primary endpoints are expected to be evaluated as percent of patients with complications compared between the two groups. Secondary outcomes will be represented descriptively and analysed according to the datatype. An interim analysis will be performed when 50% of the patients are enrolled in the study. Statistical analysis will be undertaken using R version 3.2 or later if available.
While robot-assisted kidney transplantation is still in its experimental phase, robot-assisted surgery is not and many urological procedures use robotic assistance with excellent results. With no randomized clinical trials to date comparing RAKT to OKT, this study aims to contribute with valuable evidence on the possible benefits of RAKT for both surgical outcomes and the post-operative and long-term patient trajectory.
- Being tested
- Robot-Assisted Kidney Transplantation, Open Kidney Transplantation
- Keywords
- Kidney Transplantation, Robotic Surgery
- Medical subject headings
- Kidney Failure, Chronic
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
Robot-Assisted Kidney Transplantation takes place with the patient under general anaesthesia. Several ports are placed in the lower abdomen, for the entry of the camera, surgical instruments and manuel access. The DaVinci robot is placed between the patient's legs and docked to the ports. The iliac vascular bed is prepared and a peritoneal cavity created laterally. The kidney is introduced through the handport, regional hypothermia obtained via iceslush in the cavity and the vessel lumens flushed with heparin. The vessels are blocked during suturing with the kidney graft vessels anastomosed end-to-side to the external iliac vessels. The kidney graft is placed in the retroperitoneal cavity and a ureterovesical anastomosis performed ad modem Woodruff over double J stent. The ureter is placed extra peritoneally, fascia closed in layers and the skin using intracutaneous suturing. Perioperative prophylactics entail piperacillin/tazobactam and an indwelling bladder catheter is placed.
Open Kidney TransplantationProcedure or surgery
Open Kidney Transplantation takes place with the patient under general anaesthesia. A jockey-stick (Gibson) incision is made in the left or right iliac fossa and the peritoneum is displaced. With the kidney under hypothermia, the iliac vascular bed is prepared, the vessel lumens flushed with heparin and a vascular clamp instrument is used to block the vessels during suturing. The kidney graft vessels are anastomosed end-to-side to the external iliac vessels and the ureterovesical anastomosis performed ad modem Woodruff over a double J stent. The kidney graft is placed in the cavity and the fascia is closed in layers and the skin using intracutaneous suturing. Perioperative prophylactics entail piperacillin/tazobactam and an indwelling bladder catheter is placed.
| Study group | Role | What they receive |
|---|---|---|
| Robot-assisted Kidney Transplantation (RAKT) | Experimental | Participants will undergo standard work-up prior to transplantation according to the KDIGO guidelines, in addition, participation in the study will require a non-contrast CT of the abdomen to exclude severe calcification of the iliac vessels.
Participants will be managed according to the standard protocol for renal transplantation at Rigshospitalet and will follow standard pre-, peri- and post-operative care aside from operating modality. The anaestethic protocol will be tailored to suit robot-assisted surgery Receives: Procedure: Robot-Assisted Kidney Transplantation |
| Open Kidney Transplantation (OKT) | Active comparator | Participants will undergo standard work-up prior to transplantation according to the KDIGO guidelines, in addition, participation in the study will require a non-contrast CT of the abdomen to exclude severe calcification of the iliac vessels.
Participants will be managed according to the standard protocol for anaesthesia and renal transplantation at Rigshospitalet and will follow standard pre-, peri- and post-operative care aside from operating modality. Receives: Procedure: Open Kidney Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular complications
Composite outcome consisting of a) bleeding requiring reoperation, b) renal/graft vascular thrombosis, c) symptomatic hematomas d) renal/graft arterial stenosis
Measured: 30 days after surgery
Surgical complications Clavien-Dindo >grade 2
All postoperative complications will be recorded and graded according to the Clavien-Dindo classification with major complications defined as >grade 2.
Measured: 30 days after surgery
Secondary outcomes (26)
Length of Stay (LOS)
Duration (days) of primary hospitalization. From the date of admission until the date of discharge from hospital
Measured: 12 months
Days Alive and Out of Hospital (DAOH)
Number of days alive and out of hospital within 30 days from surgery
Measured: 30 days after surgery
Days Alive and Out of Hospital (DAOH)
Number of days alive and out of hospital within 90 days from surgery
Measured: 90 days after surgery
Quality of Life (QOL): SF-36
Patient reported health related QOL using the Short Form 36-item Health Survey
Measured: 30 days after surgery
Quality of Life (QOL): SF-36
Patient reported health related QOL using the Short Form 36-item Health Survey
Measured: 90 days after surgery
Use of analgesics
Average administered dose of any opiod agent (MME/day) post surgery, during in-hospital stay
Measured: 12 months
Transfusion rate
Total amount of red blood cells administered (units)
Measured: 30 days after surgery
Kidney Function
30-day creatinine and estimated Glomerular Filtration Rate (eGFR). Creatinine: μmol/L. eGFR calculated according to the CKD-EPI equation
Measured: 30 days after surgery
Kidney Function
90-day creatinine and estimated Glomerular Filtration Rate (eGFR). Creatinine: μmol/L. eGFR calculated according to the CKD-EPI equation
Measured: 90 days after surgery
Kidney Function
1-year creatinine and estimated Glomerular Filtration Rate (eGFR). Creatinine: μmol/L. eGFR calculated according to the CKD-EPI equation
Measured: 12 months after surgery
Kidney Function
2-year creatinine and estimated Glomerular Filtration Rate (eGFR). Creatinine: μmol/L. eGFR calculated according to the CKD-EPI equation
Measured: 24 months after surgery
Delayed Graft Function (DGF)
Need for dialysis in the first post-operative week beyond day 0, due to lack of increase in kidney function and where the cause is not urological/surgical complications or hyperkalaemia alone
Measured: 7 days after surgery
Graft loss
Start of permanent dialysis and/or allograft nephrectomy
Measured: 30 days after surgery
Graft loss
Start of permanent dialysis and/or allograft nephrectomy
Measured: 90 days after surgery
Graft loss
Start of permanent dialysis and/or allograft nephrectomy
Measured: 24 months after surgery
30-day Mortality
30-day all cause mortality rate and cause of death
Measured: 30 days after surgery
90-day Mortality
90-day mortality rate and cause of death
Measured: 90 days after surgery
1-year Mortality
1-year mortality rate and cause of death
Measured: 12 months after surgery
2-year Mortality
2-year mortality rate and cause of death
Measured: 24 months after surgery
Specific urological surgical complications
Ureteral strictures, urinary leak, hydronephrosis, symptomatic lymphocele; including, when needed, designated intervention (nephrostomy, JJ stent, reimplantation, drain, surgery)
Measured: 30 days after surgery
Late & specific urological surgical complications
Ureteral strictures, urinary leak, hydronephrosis, symptomatic lymphocele; including, when needed, designated intervention (nephrostomy, JJ stent, reimplantation, drain, surgery)
Measured: 90 days after surgery
Late & specific urological surgical complications
Ureteral strictures, urinary leak, hydronephrosis, symptomatic lymphocele; including, when needed, designated intervention (nephrostomy, JJ stent, reimplantation, drain, surgery)
Measured: 24 months after surgery
Time to return to work
Whether participants have resumed a paying job 90 days after surgery. If yes: time in months from operation until any degree of work is resumed
Measured: 90 days after surgery
Recurrent urinary tract infection (UTI)
Culture confirmed recurrent UTI as defined by EAU guidelines (3 per year or 2 within 6 months)
Measured: 90 days after surgery
Recurrent urinary tract infection (UTI)
Culture confirmed recurrent UTI as defined by EAU guidelines (3 per year or 2 within 6 months)
Measured: 24 months after surgery
Rejection
Rejection within 12 months of surgery. If rejection has occurred, diagnostic category according to Banff Classification of Renal Allograft Pathology.
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start8 May 2023
- Primary completion26 Oct 2025
- Study completion26 Oct 2027 (estimated)
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 End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Milla Ortved, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Andreas Roeder, MD, PhD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730257
- Sponsor's protocol ID
- H-22065569
- Other IDs
- P-2022-834
- Acronym
- ORAKTx
- Status last verified
- Oct 2025
- First submitted
- 7 Feb 2023
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All study data including study protocol, statistical analysis plan, informed consent form, and clinical study report can be shared when a proper agreement is formed according to the European Union (EU) General Data Protection Regulation (GDPR) protection statement.
Publications
Ortved M, Dagnaes-Hansen J, Stroomberg HV, Kistorp T, Rohrsted M, Sorensen SS, Roder A. Open-label randomised clinical trial investigating whether robot-assisted kidney transplantation can reduce surgical complications compared to open kidney transplantation (ORAKTx): study protocol for a randomised clinical trial. Trials. 2025 Jan 6;26(1):8. doi: 10.1186/s13063-024-08706-5.
PubMed 39762978
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Randomized Clinical Trial Investigating Whether Robot-Assisted Kidney Transplantation Can Reduce Surgical Complications Compared to Open Kidney Transplantation; The ORAKTx Trial
- ClinicalTrials.gov ID
- NCT05730257
- Acronym / sponsor ID
- ORAKTx / H-22065569
- Keywords
- Kidney Transplantation, Robotic Surgery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 8 May 2023 (actual)
- Primary completion
- 26 Oct 2025 (actual)
- Study completion
- 26 Oct 2027 (estimated)
- First posted
- 15 Feb 2023 (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.
The purpose of this study is to explore whether robot-assisted surgery can reduce 30-day surgical complications compared to open surgery in kidney transplantation.
Participants are adult recipients of kidney transplantation. Upon entry into the trial participants will be randomly assigned eiher open kidney transplantation or robot-assisted kidney transplantation. The participants in both groups will be treated in accordance with up-to-date guidelines and care.
Our hypothesis is that robot-assisted surgery can reduce vascular complications by 15% and/or major surgical complicatons by 20% within 30 days of kidney transplantation compared to open surgery.
Detailed description
Kidney transplantation is the ultimate surgical treatment for end stage renal disease, and while medical transplantation therapy has developed tremendously and now allows for transplantation and long-term survival, even in seemingly incompatible donors and recipients, kidney graft survival still, to a large extent, depends on a smooth and complication-free surgical procedure. In the past decade surgical techniques have been expanded by the introduction of surgical robots to improve minimally invasive surgery and optimize post-surgical care. Previous studies suggest that robot-assisted surgery has the potential to reduce complications such as surgical site infection and blood-loss, facilitate fast-track or even ambulatory surgery for complicated procedures and recent studies suggest this may be the case for kidney transplantation too.
The aim of this trial is therefore to explore if robot-assisted surgery can reduce surgical complications following kidney transplantation compared to open surgery (standard of care) and investigate the patient trajectory following the two procedures in terms of late complications, graft function and mortality. The study design is a superiority, open-label randomized clinical trial to be conducted at Rigshospitalet, the largest transplantation centre in Denmark.
The primary outcomes consist of 1) reduction in vascular complications (graft arterial stenosis, bleeding requiring reoperation, symptomatic haematomas, renal vascular thrombosis). The rate of vascular complications is currently 17.3%. With a power set at 80% and a significance level set at 5% we hypothesize that Robot-Assisted Kidney Transplantation (RAKT) can reduce vascular complications by 15% within 30 days after transplantation compared to Open Kidney Transplantation (OKT). 2) Reduction in surgical complications Clavien-Dindo > grade 2. The rate of Clavien-Dindo >2 is currently 22.8%.
With a power set at 80% and a significance level set at 5%, we hypothesize that RAKT can reduce Clavien-Dindo >2 by 20% within 30 days after transplantation compared to OKT.
The study will randomize 106 participants with an anticipated drop-out of 10% (n=96). Immediate follow-up will be 30-days after kidney transplantation to observe occurrence of primary endpoints assessed by chart review including both in- and out-patient information. Follow-up through chart review will persist for 2 years in order to monitor long-term complications and assess secondary outcomes. Participants will be randomized with a 1:1 allocation ratio using the randomization module in REDCap with differing block sizes. Dropouts will be replaced by the same randomization number to ensure equal distribution.
The study is analysed as intention-to-treat. The primary endpoints are expected to be evaluated as percent of patients with complications compared between the two groups. Secondary outcomes will be represented descriptively and analysed according to the datatype. An interim analysis will be performed when 50% of the patients are enrolled in the study. Statistical analysis will be undertaken using R version 3.2 or later if available.
While robot-assisted kidney transplantation is still in its experimental phase, robot-assisted surgery is not and many urological procedures use robotic assistance with excellent results. With no randomized clinical trials to date comparing RAKT to OKT, this study aims to contribute with valuable evidence on the possible benefits of RAKT for both surgical outcomes and the post-operative and long-term patient trajectory.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot-assisted Kidney Transplantation (RAKT) | Experimental | Procedure: Robot-Assisted Kidney TransplantationParticipants will undergo standard work-up prior to transplantation according to the KDIGO guidelines, in addition, participation in the study will require a non-contrast CT of the abdomen to exclude severe calcification of the iliac vessels. Participants will be managed according to the standard protocol for renal transplantation at Rigshospitalet and will follow standard pre-, peri- and post-operative care aside from operating modality. The anaestethic protocol will be tailored to suit robot-assisted surgery |
| Open Kidney Transplantation (OKT) | Active comparator | Procedure: Open Kidney TransplantationParticipants will undergo standard work-up prior to transplantation according to the KDIGO guidelines, in addition, participation in the study will require a non-contrast CT of the abdomen to exclude severe calcification of the iliac vessels. Participants will be managed according to the standard protocol for anaesthesia and renal transplantation at Rigshospitalet and will follow standard pre-, peri- and post-operative care aside from operating modality. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult recipients for renal transplantation
- Both patients in dialysis as well as pre-emptive
- For recipients of kidney grafts from deceased donors, inclusion depends on the availabilty of the robotic platform and dedicated surgical team
Key exclusion criteria (7 listed)
- High degree of calcification of the iliac vessels on the level of external iliac artery defined as occurrence of longitudinal plaques on non-contrast CT-scan or other relevant radiological imaging in recipient prior to transplantation
- Highly complex vascular anatomy in the donor kidney requiring multiple anastomoses as evaluated by surgeon
- Previous kidney transplantation with later allograft nephrectomy as evaluated by the surgeon preoperatively
- Patients whose abdominal anatomy may prohibit access to and placement of graft in the iliac fossa as evaluated by the surgeon preoperatively (i.e. previous laparotomy, rectal surgery, herniotomy, current multiple kidney cysts)
- Simultaneous multiple organ transplant
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 TransplantationRobot-Assisted Kidney Transplantation takes place with the patient under general anaesthesia. Several ports are placed in the lower abdomen, for the entry of the camera, surgical instruments and manuel access. The DaVinci robot is placed between the patient's legs and docked to the ports. The iliac vascular bed is prepared and a peritoneal cavity created laterally. The kidney is introduced through the handport, regional hypothermia obtained via iceslush in the cavity and the vessel lumens flushed with heparin. The vessels are blocked during suturing with the kidney graft vessels anastomosed end-to-side to the external iliac vessels. The kidney graft is placed in the retroperitoneal cavity and a ureterovesical anastomosis performed ad modem Woodruff over double J stent. The ureter is placed extra peritoneally, fascia closed in layers and the skin using intracutaneous suturing. Perioperative prophylactics entail piperacillin/tazobactam and an indwelling bladder catheter is placed. | Procedure or surgery | Robot-assisted Kidney Transplantation (RAKT) |
| Open Kidney TransplantationOpen Kidney Transplantation takes place with the patient under general anaesthesia. A jockey-stick (Gibson) incision is made in the left or right iliac fossa and the peritoneum is displaced. With the kidney under hypothermia, the iliac vascular bed is prepared, the vessel lumens flushed with heparin and a vascular clamp instrument is used to block the vessels during suturing. The kidney graft vessels are anastomosed end-to-side to the external iliac vessels and the ureterovesical anastomosis performed ad modem Woodruff over a double J stent. The kidney graft is placed in the cavity and the fascia is closed in layers and the skin using intracutaneous suturing. Perioperative prophylactics entail piperacillin/tazobactam and an indwelling bladder catheter is placed. | Procedure or surgery | Open Kidney Transplantation (OKT) |
Primary outcome
Vascular complications
Time frame: 30 days after surgery
Composite outcome consisting of a) bleeding requiring reoperation, b) renal/graft vascular thrombosis, c) symptomatic hematomas d) renal/graft arterial stenosis
Surgical complications Clavien-Dindo >grade 2
Time frame: 30 days after surgery
All postoperative complications will be recorded and graded according to the Clavien-Dindo classification with major complications defined as >grade 2.
26 secondary outcomes
Length of Stay (LOS)
Time frame: 12 months
Days Alive and Out of Hospital (DAOH)
Time frame: 30 days after surgery
Days Alive and Out of Hospital (DAOH)
Time frame: 90 days after surgery
Quality of Life (QOL): SF-36
Time frame: 30 days after surgery
Quality of Life (QOL): SF-36
Time frame: 90 days after surgery
Use of analgesics
Time frame: 12 months
Transfusion rate
Time frame: 30 days after surgery
Kidney Function
Time frame: 30 days after surgery
Kidney Function
Time frame: 90 days after surgery
Kidney Function
Time frame: 12 months after surgery
Kidney Function
Time frame: 24 months after surgery
Delayed Graft Function (DGF)
Time frame: 7 days after surgery
Graft loss
Time frame: 30 days after surgery
Graft loss
Time frame: 90 days after surgery
Graft loss
Time frame: 24 months after surgery
30-day Mortality
Time frame: 30 days after surgery
90-day Mortality
Time frame: 90 days after surgery
1-year Mortality
Time frame: 12 months after surgery
2-year Mortality
Time frame: 24 months after surgery
Specific urological surgical complications
Time frame: 30 days after surgery
Late & specific urological surgical complications
Time frame: 90 days after surgery
Late & specific urological surgical complications
Time frame: 24 months after surgery
Time to return to work
Time frame: 90 days after surgery
Recurrent urinary tract infection (UTI)
Time frame: 90 days after surgery
Recurrent urinary tract infection (UTI)
Time frame: 24 months after surgery
Rejection
Time frame: 12 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Derived from this study: PubMed 39762978Ortved M, Dagnaes-Hansen J, Stroomberg HV, Kistorp T, Rohrsted M, Sorensen SS, Roder A. Open-label randomised clinical trial investigating whether robot-assisted kidney transplantation can reduce surgical complications compared to open kidney transplantation (ORAKTx): study protocol for a randomised clinical trial. Trials. 2025 Jan 6;26(1):8. doi: 10.1186/s13063-024-08706-5.
- Individual participant dataSharing planned: No. All study data including study protocol, statistical analysis plan, informed consent form, and clinical study report can be shared when a proper agreement is formed according to the European Union (EU) General Data Protection Regulation (GDPR) protection statement.
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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.
Andreas Roeder, MD, PhD principal investigator
Copenhagen University Hospital, Rigshospitalet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-Assisted Kidney Transplantation and Open Kidney Transplantation in people with End Stage Renal Disease and Kidney Transplant; Complications, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
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 7 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: under way, not looking for participants, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
This study is still under way. Results are not available in the source record yet.
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?
Vascular complications (time frame: 30 days after surgery). 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 NCT05730257, 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 9 Dec 2025.