Kidney Transplant; ComplicationsPTV-DSAaKTNCT06425497
DE NOVO DONOR SPECIFIC ANTIBODIES AFTER KIDNEY TRANSPLANTATION: SINGLE-CENTER RETROSPECTIVE STUDY
An observational study of Kidney Transplant; Complications and Immunosuppression, run by University of Rome Tor Vergata.
Trial summary
To investigate the variations of Donor Specific Antibodies in kidney transplant patients based on the type of immunosuppressive therapy adopted and immunosuppressive blood levels. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Kidney Transplant; Complications, Immunosuppression
- What is being tested?
- The dosage of dnDSA
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 6 May 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be composed by patients who underwent a kidney transplant, single or double, from a deceased or living donor, from 01/01/2010 to 07/31/2023 at the U.O.C. of the Hepatobiliary Surgery and Transplants of the Tor Vergata Polyclinic, with at least one year of post-transplant follow-up.
Who may be able to join
- Patients,both male and female over the age of 18
- Patients with at least one year of follow-up
Who cannot join
- Combined liver-kidney or pancreas-kidney transplants
- Re-transplants
- Patients with follow-up less than one year
About this study
To investigate the variations of Donor Specific Antibodies in kidney transplant patients based on the type of immunosuppressive therapy adopted and immunosuppressive blood levels.
Read the detailed description
Retrospective observational monocentric study at the U.O.C. of Hepatobiliary Surgery and Transplants of Tor Vergata Polyclinic. All kidney transplant patients in the indicated study period will be enrolled and followed at the U.O.C. clinic.
For each patient, demographic, transplant and post-transplant data will be collected. In the latter, data relating to dnDSA will be registered, searching for a possible triggering cause at the anamnestic level.
The dosage of dnDSA is performed in common clinical practice in a routine manner in all patients undergoing kidney transplant, using the method "Flow cytometric analysis using FlowPRA Screening Test and/or Luminex Single Antigen Beads class I and II- IgG (cut- positivity off = MFI> 1000)".
The blood dosage of the immunosuppressor is measured during routine checks and a comparison is made between Tacrolimus-based immunosuppressive therapy and other immunosuppressive therapy, highlighting the differences in the risk of developing dnDSA and in graft and patient survival.
- Being tested
- The dosage of dnDSA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The dosage of dnDSAOther
Flow cytometric analysis using FlowPRA Screening Test and/or Luminex Single Antigen Beads class I and II- IgG (cut- positivity off = MFI> 1000)
| Study group | Role | What they receive |
|---|---|---|
| Kidney transplant patients | The study population will be composed by patients who underwent a kidney transplant, single or double, from a deceased or living donor, from 01/01/2010 to 07/31/2023 at the U.O.C. of the Hepatobiliary Surgery and Transplants of the Tor Vergata Polyclinic, with at least one year of post-transplant follow-up. Receives: Other: The dosage of dnDSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of dnDSA in kidney transplant patients
Define the incidence of development of dnDSA in patients undergoing kidney transplantation.
Measured: • Pre-transplant • Baseline (I PODs) • At one week • At one month • At 3 months • At 6 months • At one year • At 5 years old • At 10 years old
Secondary outcomes (4)
Graft survival
Graft survival At 5 and 10 years
Measured: 5 and 10 years
Patient survival
Patient survival at 5 and 10 years
Measured: 5 and 10 years
Blood dosage levels of post-transplant immunosuppressive drugs
Blood dosage levels of post-transplant immunosuppressive drugs (tacrolemia, ciclosporinemia, everolemia, sirolemia);
Measured: • At one week • At one month • At 3 months • At 6 months • At one year • At 5 years old • At 10 years old
Donor-recipient HLA mismatch
Donor-recipient HLA mismatch
Measured: Pre-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start1 Jan 2010
- Primary completion31 Jul 2023
- Study completion6 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant; ComplicationsStudies 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
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberta Angelico, University of Rome Tor Vergata
- Investigators
- Roberta Angelico, MD, Principal investigator, University of Rome Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06425497
- Sponsor's protocol ID
- sperimentazioni PTV 92.24
- Acronym
- PTV-DSAaKT
- Status last verified
- May 2024
- First submitted
- 17 May 2024
- Last updated
- 29 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DE NOVO DONOR SPECIFIC ANTIBODIES AFTER KIDNEY TRANSPLANTATION: SINGLE-CENTER RETROSPECTIVE STUDY
- ClinicalTrials.gov ID
- NCT06425497
- Acronym / sponsor ID
- PTV-DSAaKT / sperimentazioni PTV 92.24
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 6 May 2024 (actual)
- First posted
- 22 May 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.
To investigate the variations of Donor Specific Antibodies in kidney transplant patients based on the type of immunosuppressive therapy adopted and immunosuppressive blood levels.
Detailed description
Retrospective observational monocentric study at the U.O.C. of Hepatobiliary Surgery and Transplants of Tor Vergata Polyclinic. All kidney transplant patients in the indicated study period will be enrolled and followed at the U.O.C. clinic.
For each patient, demographic, transplant and post-transplant data will be collected. In the latter, data relating to dnDSA will be registered, searching for a possible triggering cause at the anamnestic level.
The dosage of dnDSA is performed in common clinical practice in a routine manner in all patients undergoing kidney transplant, using the method "Flow cytometric analysis using FlowPRA Screening Test and/or Luminex Single Antigen Beads class I and II- IgG (cut- positivity off = MFI> 1000)".
The blood dosage of the immunosuppressor is measured during routine checks and a comparison is made between Tacrolimus-based immunosuppressive therapy and other immunosuppressive therapy, highlighting the differences in the risk of developing dnDSA and in graft and patient survival.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kidney transplant patients | – | Other: The dosage of dnDSAThe study population will be composed by patients who underwent a kidney transplant, single or double, from a deceased or living donor, from 01/01/2010 to 07/31/2023 at the U.O.C. of the Hepatobiliary Surgery and Transplants of the Tor Vergata Polyclinic, with at least one year of post-transplant follow-up. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be composed by patients who underwent a kidney transplant, single or double, from a deceased or living donor, from 01/01/2010 to 07/31/2023 at the U.O.C. of the Hepatobiliary Surgery and Transplants of the Tor Vergata Polyclinic, with at least one year of post-transplant follow-up.
Key inclusion criteria (2 listed)
- Patients,both male and female over the age of 18
- Patients with at least one year of follow-up
Key exclusion criteria (3 listed)
- Combined liver-kidney or pancreas-kidney transplants
- Re-transplants
- Patients with follow-up less than one year
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 |
|---|---|---|
| The dosage of dnDSAFlow cytometric analysis using FlowPRA Screening Test and/or Luminex Single Antigen Beads class I and II- IgG (cut- positivity off = MFI> 1000) | Other | Kidney transplant patients |
Primary outcome
Development of dnDSA in kidney transplant patients
Time frame: • Pre-transplant • Baseline (I PODs) • At one week • At one month • At 3 months • At 6 months • At one year • At 5 years old • At 10 years old
Define the incidence of development of dnDSA in patients undergoing kidney transplantation.
4 secondary outcomes
Graft survival
Time frame: 5 and 10 years
Patient survival
Time frame: 5 and 10 years
Blood dosage levels of post-transplant immunosuppressive drugs
Time frame: • At one week • At one month • At 3 months • At 6 months • At one year • At 5 years old • At 10 years old
Donor-recipient HLA mismatch
Time frame: Pre-transplant
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 29 May 2024.
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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.
Roberta Angelico, MD principal investigator
University of Rome Tor Vergata
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant; Complications and Immunosuppression, run by University of Rome Tor Vergata.
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 2 inclusion and 3 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 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Development of dnDSA in kidney transplant patients (time frame: • Pre-transplant • Baseline (I PODs) • At one week • At one month • At 3 months • At 6 months • At one year • At 5 years old • At 10 years old). 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 29 May 2024.