Kidney TransplantationNCT05651906
The Role of Endothelial Glycocalyx in Kidney Transplantation
An observational study of Kidney Transplantation, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
The goal of this observational study is detailed examination of endothelial glycocalyx in kidney transplantation. Researchers will evaluate markers of degradation of EG in blood and urine; and also perform direct visualisation of EG with sidestream dark field imaging (SDF) in both donors and recipients of kidney… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Kidney Transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Dec 2022to 31 May 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Group 1: Donors after brain death, Donors after circulatory death Group 2: Patients with end-stage renal disease who are eligible for kidney transplantation
Who may be able to join
- Patients undergoing kidney transplantation
Who cannot join
- Patients who don't sign the informed consent
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Hradec Kralove
Hradec Králové, Czech Republic, 50002
Pavel Navratil, 00420495833378, pavel.navratil2@fnhk.cz
About this study
The goal of this observational study is detailed examination of endothelial glycocalyx in kidney transplantation. Researchers will evaluate markers of degradation of EG in blood and urine; and also perform direct visualisation of EG with sidestream dark field imaging (SDF) in both donors and recipients of kidney transplantation.
The aim is to summarize the current knowledge and to point out the importance of EG in kidney transplantation.
Read the detailed description
The endothelial glycocalyx (EG) is a thin layer on the surface of the endothelium that plays an important role for microcirculation and tissue metabolism. The role of EG is diverse - it acts as a protection of the endothelium against shear stress which is mediated on the intracellular structures of endothelial cells, allows the interaction of blood elements and endothelium, prevents the formation of uncontrolled thrombosis and excessive oxidative stress by free radicals. EG dysfunction can occur with partial or complete loss of its components, resulting in impaired vascular regulation and increased vascular permeability. Disruption or dysfunction of EG has been associated with disease states such as diabetes, chronic kidney disease, inflammatory conditions, sepsis, hypernatraemia, hypervolaemia and ischaemia/reperfusion injury. Enzymes such as hyaluronidase and metalloproteinases can degrade the components of EG. Damage to EG leads to the release of breakdown products into the bloodstream which can be detected. There are also direct methods of visualization of EG. Thanks to advances in the study of EG in kidney transplantation a comprehensive relationship in this field and specific clinical aspects can be assessed. In the future exploring potential therapeutic options to protect EG may have implications for better graft function and survival.
- Conditions
- Kidney Transplantation
- Being tested
- Kidney Transplantation
- Keywords
- Endothelial, Glycocalyx
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kidney TransplantationProcedure or surgery
Kidney transplantation as the best option for patients with end-stage kidney disease.
| Study group | Role | What they receive |
|---|---|---|
| Donors | Not described | |
| Recipients | Not described Receives: Procedure: Kidney Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examination of Endothelial Glycocalyx in Donors
Correlation between the status of EG in donors and kidney function after kidney transplantation (
Measured: 1 year
Examination of Endothelial Glycocalyx in Recipients
Description of microcirculation directly from the kidney's surface in 1 and 20 minutes after reperfusion (with Side stream darkfield imaging and Perfused boundary region)
Measured: 1 year
Secondary outcomes (1)
Endothelial Glycocalyx under different settings
Description of EG in living donors, donors after brain death, donors after circulatory death (measurements of degradation products od EG - mainly syndecan-1 in blood and urine)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start1 Dec 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pavel Navrátil, MUDr., FEBU, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651906
- Sponsor's protocol ID
- GCX-KTX
- Status last verified
- Feb 2024
- First submitted
- 14 Nov 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Endothelial Glycocalyx in Kidney Transplantation
- ClinicalTrials.gov ID
- NCT05651906
- Acronym / sponsor ID
- GCX-KTX
- Conditions
- Kidney Transplantation
- Keywords
- Endothelial, Glycocalyx
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 15 Dec 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.
The goal of this observational study is detailed examination of endothelial glycocalyx in kidney transplantation. Researchers will evaluate markers of degradation of EG in blood and urine; and also perform direct visualisation of EG with sidestream dark field imaging (SDF) in both donors and recipients of kidney transplantation.
The aim is to summarize the current knowledge and to point out the importance of EG in kidney transplantation.
Detailed description
The endothelial glycocalyx (EG) is a thin layer on the surface of the endothelium that plays an important role for microcirculation and tissue metabolism. The role of EG is diverse - it acts as a protection of the endothelium against shear stress which is mediated on the intracellular structures of endothelial cells, allows the interaction of blood elements and endothelium, prevents the formation of uncontrolled thrombosis and excessive oxidative stress by free radicals. EG dysfunction can occur with partial or complete loss of its components, resulting in impaired vascular regulation and increased vascular permeability. Disruption or dysfunction of EG has been associated with disease states such as diabetes, chronic kidney disease, inflammatory conditions, sepsis, hypernatraemia, hypervolaemia and ischaemia/reperfusion injury. Enzymes such as hyaluronidase and metalloproteinases can degrade the components of EG. Damage to EG leads to the release of breakdown products into the bloodstream which can be detected. There are also direct methods of visualization of EG. Thanks to advances in the study of EG in kidney transplantation a comprehensive relationship in this field and specific clinical aspects can be assessed. In the future exploring potential therapeutic options to protect EG may have implications for better graft function and survival.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Donors | – | – |
| Recipients | – | Procedure: Kidney Transplantation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Group 1: Donors after brain death, Donors after circulatory death Group 2: Patients with end-stage renal disease who are eligible for kidney transplantation
Key inclusion criteria (1 listed)
- Patients undergoing kidney transplantation
Key exclusion criteria (1 listed)
- Patients who don't sign the informed consent
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 |
|---|---|---|
| Kidney TransplantationKidney transplantation as the best option for patients with end-stage kidney disease. | Procedure or surgery | Recipients |
Primary outcome
Examination of Endothelial Glycocalyx in Donors
Time frame: 1 year
Correlation between the status of EG in donors and kidney function after kidney transplantation (
Examination of Endothelial Glycocalyx in Recipients
Time frame: 1 year
Description of microcirculation directly from the kidney's surface in 1 and 20 minutes after reperfusion (with Side stream darkfield imaging and Perfused boundary region)
1 secondary outcome
Endothelial Glycocalyx under different settings
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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?
An observational study of Kidney Transplantation, run by Charles University, Czech Republic at 1 site in Czechia.
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 1 inclusion and 1 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 28 Feb 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 Czechia. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Examination of Endothelial Glycocalyx in Donors (time frame: 1 year). 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?
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 28 Feb 2024.