Kidney TransplantNCT07008131
Impact of Double J Catheter in Major Urological Complications in Renal Transplant Recipients
A study testing Double J stent and No Double J stent in people with Kidney Transplant and Urinary Complications, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial summary
Renal transplantation is the renal replacement therapy of choice in patients with end-stage chronic kidney disease. Major urological complications such as urinary leakage, ureteral stricture and urinary tract infections are usually observed in the first three months post-transplantation and lead to higher morbidity… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant, Urinary Complications, Double J Stent
- What is being tested?
- Double J stent and No Double J stent
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jan 2022to 31 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Renal transplantation candidates
- They agree to participate in the study
Who cannot join
- Previous renal transplantation
- Urinary tract malformations
- Urinary reservoir carriers
- Known neurogenic disease of the urinary tract
- Cadaveric donor grafts
- Grafts with double collecting system
- Patients whose trans-surgical findings require catheter placement.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Unidad de Investigación Biomédica 02, Hospital de Especialidades, Centro Médico Nacional de Occidente
Guadalajara, Jalisco, 44298
About this study
Official title: Impact on Major Urologic Complications With Prophylactic Use of Double J Catheter in Extravesical Ureteroneocystostomy in Renal Transplant Recipients
Renal transplantation is the renal replacement therapy of choice in patients with end-stage chronic kidney disease. Major urological complications such as urinary leakage, ureteral stricture and urinary tract infections are usually observed in the first three months post-transplantation and lead to higher morbidity and mortality and lower graft function.
To evaluate the use of the double J catheter on major urological complications in extravesical ureteroneocystostomy in renal recipients.
Open clinical trial. Renal transplant recipients were included, who underwent extravesical ureteroneocystostomy with trans-surgical placement of double J catheter compared to extravesical ureteroneocystostomy without trans-surgical catheter placement. The study variables were urinary leakage, ureteral stricture, urinary tract infection, surgical complications and graft function.
- Conditions
- Kidney Transplant, Urinary Complications, Double J Stent
- Being tested
- Double J stent, No Double J stent
- Keywords
- Kidney Transplant, Urinary Complications, Double J stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double J stentDevice
Extravesical ureteroneocystostomy with double J-catheter placement
No Double J stentProcedure or surgery
Extravesical ureteroneocystostomy with no Double J stent colocation
| Study group | Role | What they receive |
|---|---|---|
| Double J catheter colocation | Experimental | Double J catheter colocation in extravesical ureteroneocystostomy Receives: Device: Double J stent |
| No double J catheter colocation | Active comparator | Extravesical ureteroneocystostomy with no double J catheter colocation Receives: Procedure: No Double J stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major urological complications
Urinary leakage, uretheral stenosis and urinary infection
Measured: From enrollment to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start1 Jan 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies 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
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Clotilde Fuentes-Orozco, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008131
- Sponsor's protocol ID
- R-2018-1001-201
- Status last verified
- May 2025
- First submitted
- 29 May 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Major Urologic Complications With Prophylactic Use of Double J Catheter in Extravesical Ureteroneocystostomy in Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT07008131
- Acronym / sponsor ID
- R-2018-1001-201
- Conditions
- Kidney Transplant, Urinary Complications, Double J Stent
- Keywords
- Kidney Transplant, Urinary Complications, Double J stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 6 Jun 2025 (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.
Renal transplantation is the renal replacement therapy of choice in patients with end-stage chronic kidney disease. Major urological complications such as urinary leakage, ureteral stricture and urinary tract infections are usually observed in the first three months post-transplantation and lead to higher morbidity and mortality and lower graft function.
To evaluate the use of the double J catheter on major urological complications in extravesical ureteroneocystostomy in renal recipients.
Open clinical trial. Renal transplant recipients were included, who underwent extravesical ureteroneocystostomy with trans-surgical placement of double J catheter compared to extravesical ureteroneocystostomy without trans-surgical catheter placement. The study variables were urinary leakage, ureteral stricture, urinary tract infection, surgical complications and graft function.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Double J catheter colocation | Experimental | Device: Double J stentDouble J catheter colocation in extravesical ureteroneocystostomy |
| No double J catheter colocation | Active comparator | Procedure: No Double J stentExtravesical ureteroneocystostomy with no double J catheter colocation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- Renal transplantation candidates
- They agree to participate in the study
Key exclusion criteria (7 listed)
- Previous renal transplantation
- Urinary tract malformations
- Urinary reservoir carriers
- Known neurogenic disease of the urinary tract
- Cadaveric donor grafts
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 |
|---|---|---|
| Double J stentExtravesical ureteroneocystostomy with double J-catheter placement | Device | Double J catheter colocation |
| No Double J stentExtravesical ureteroneocystostomy with no Double J stent colocation | Procedure or surgery | No double J catheter colocation |
Primary outcome
Major urological complications
Time frame: From enrollment to three months
Urinary leakage, uretheral stenosis and urinary infection
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 6 Jun 2025.
- Individual participant dataSharing planned: No
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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?
A study testing Double J stent and No Double J stent in people with Kidney Transplant and Urinary Complications, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
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: finished, as of the sponsor's last update on 6 Jun 2025. 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 Mexico. 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?
Major urological complications (time frame: From enrollment to three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2025.