Kidney Transplant RejectionNCT03714113
Donor-specific Anti-HLA Antibodies Monitoring in Kidney Transplant Recipients
A study testing Anti-HLA donor-specific antibodies monitoring in people with Kidney Transplant Rejection, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The aim of this study is to evaluate whether anti-HLA donor-specific antibodies monitoring can be used as an effective tool for stratification of immunological risk in Polish kidney transplant recipients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Rejection
- What is being tested?
- Anti-HLA donor-specific antibodies monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 1 Oct 2018to Dec 2021
- 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
- Deceased-donor kidney transplant recipient
- Older than 18 years
- Written consent by the patient
Who cannot join
- Younger than 18 years
- Lack of written consent by the patient
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Transplantation Medicine, Nephrology and Internal Medicine
Warsaw, 02-006
About this study
Official title: Clinical Significance of Donor-specific Anti-HLA Antibodies Monitoring in Kidney Transplant Recipients
The aim of this study is to evaluate whether anti-HLA donor-specific antibodies monitoring can be used as an effective tool for stratification of immunological risk in Polish kidney transplant recipients.
Read the detailed description
Monitoring of immune response is one of the most important goals in the management of the patients after kidney transplantation. Researchers and clinicians are trying to extend the survival of the renal graft. Currently, it is believed that the main cause of late transplant loss is antibody-mediated rejection (ABMR). Anti-HLA donor-specific antibodies (DSA) are a proven risk factor for the development of humoral rejection and transplant loss. Antibodies in sensitized recipients occur before transplantation (preformed) or may develop de novo (in 13% -30% of patients).
DSA damage the graft in various mechanisms (complement activation, direct influence on endothelial cells, antibody-dependent cytotoxicity) leading to different clinical-morphological phenotypes. The pathogenicity of DSA is determined by number of their additional characteristics, such as: class, specificity, strength, C1q complement binding, IgG subclass . Monitoring the presence of DSA in the kidney recipient serum with the determination of their characteristics may improve the stratification of the risk of immunological loss of the renal allograft.
There is no effective treatment for ABMR, hence DSA monitoring allows for early intervention such as biopsy or modification of immunosuppressive therapy at an early stage of rejection.
- Conditions
- Kidney Transplant Rejection
- Being tested
- Anti-HLA donor-specific antibodies monitoring
- Keywords
- Donor-specific antibodies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-HLA donor-specific antibodies monitoringDiagnostic test
Monitoring anti-HLA donor-specific antibodies in the patients serum at the time of kidney transplantation and 3, 12 and 24 months after the procedure. Blood samples from patients will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Kidney transplant recipients. | Experimental | Patients who undergo kidney transplant in 2018 or 2019. Receives: Diagnostic Test: Anti-HLA donor-specific antibodies monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of anti-HLA donor-specific antibodies.
Binary variable (positive/negative).
Measured: 24 months
Secondary outcomes (6)
Mean fluorescence intensity (MFI) of anti-HLA DSA.
Assessed when anti-HLA DSA positive. Mean fluorescence intensity (MFI) of anti-HLA DSA. [units]
Measured: 24 months
Presence of C1q complement binding anti-HLA DSA.
Assessed when anti-HLA DSA positive. Binary variable (positive/negative).
Measured: 24 months
Presence of IgG1 subclass of anti-HLA DSA.
Assessed when anti-HLA DSA positive. Binary variable (positive/negative).
Measured: 24 months
Presence of IgG2 subclass of anti-HLA DSA.
Assessed when anti-HLA DSA positive. Binary variable (positive/negative).
Measured: 24 months
Presence of IgG3 subclass of anti-HLA DSA.
Assessed when anti-HLA DSA positive. Binary variable (positive/negative).
Measured: 24 months
Presence of IgG4 subclass of anti-HLA DSA.
Assessed when anti-HLA DSA positive. Binary variable (positive/negative).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start1 Oct 2018
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant RejectionStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Higher Education, Poland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714113
- Sponsor's protocol ID
- DI2017 002147
- Status last verified
- Mar 2021
- First submitted
- 3 Oct 2018
- Last updated
- 9 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Significance of Donor-specific Anti-HLA Antibodies Monitoring in Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT03714113
- Acronym / sponsor ID
- DI2017 002147
- Conditions
- Kidney Transplant Rejection
- Keywords
- Donor-specific antibodies
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- Ministry of Science and Higher Education, Poland
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 22 Oct 2018 (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 aim of this study is to evaluate whether anti-HLA donor-specific antibodies monitoring can be used as an effective tool for stratification of immunological risk in Polish kidney transplant recipients.
Detailed description
Monitoring of immune response is one of the most important goals in the management of the patients after kidney transplantation. Researchers and clinicians are trying to extend the survival of the renal graft. Currently, it is believed that the main cause of late transplant loss is antibody-mediated rejection (ABMR). Anti-HLA donor-specific antibodies (DSA) are a proven risk factor for the development of humoral rejection and transplant loss. Antibodies in sensitized recipients occur before transplantation (preformed) or may develop de novo (in 13% -30% of patients).
DSA damage the graft in various mechanisms (complement activation, direct influence on endothelial cells, antibody-dependent cytotoxicity) leading to different clinical-morphological phenotypes. The pathogenicity of DSA is determined by number of their additional characteristics, such as: class, specificity, strength, C1q complement binding, IgG subclass . Monitoring the presence of DSA in the kidney recipient serum with the determination of their characteristics may improve the stratification of the risk of immunological loss of the renal allograft.
There is no effective treatment for ABMR, hence DSA monitoring allows for early intervention such as biopsy or modification of immunosuppressive therapy at an early stage of rejection.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kidney transplant recipients. | Experimental | Diagnostic Test: Anti-HLA donor-specific antibodies monitoringPatients who undergo kidney transplant in 2018 or 2019. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Deceased-donor kidney transplant recipient
- Older than 18 years
- Written consent by the patient
Key exclusion criteria (2 listed)
- Younger than 18 years
- Lack of written consent by the patient
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 |
|---|---|---|
| Anti-HLA donor-specific antibodies monitoringMonitoring anti-HLA donor-specific antibodies in the patients serum at the time of kidney transplantation and 3, 12 and 24 months after the procedure. Blood samples from patients will be collected. | Diagnostic test | Kidney transplant recipients. |
Primary outcome
Presence of anti-HLA donor-specific antibodies.
Time frame: 24 months
Binary variable (positive/negative).
6 secondary outcomes
Mean fluorescence intensity (MFI) of anti-HLA DSA.
Time frame: 24 months
Presence of C1q complement binding anti-HLA DSA.
Time frame: 24 months
Presence of IgG1 subclass of anti-HLA DSA.
Time frame: 24 months
Presence of IgG2 subclass of anti-HLA DSA.
Time frame: 24 months
Presence of IgG3 subclass of anti-HLA DSA.
Time frame: 24 months
Presence of IgG4 subclass of anti-HLA DSA.
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Kidney Transplant Rejection
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Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
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(TNX-1500) in Kidney Transplant Recipients
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A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
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Not yet recruitingObservational study
Assessment of Perceived Stress in an Observational Study Evaluating a Biopsy-sparing Surveillance Strategy in Kidney Transplant Recipients With Blood and Urinary Biomarkers Predictive of the Absence of Rejection
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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 Anti-HLA donor-specific antibodies monitoring in people with Kidney Transplant Rejection, run by Medical University of Warsaw at 1 site in Poland.
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 2 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 9 Mar 2021. 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 Poland. 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?
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?
Presence of anti-HLA donor-specific antibodies. (time frame: 24 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 9 Mar 2021.