Kidney Transplant RejectionNCT04154267
Protocol Biopsies in High-risk Renal Transplant Recipients
A study testing Percutaneous renal biopsy. in people with Kidney Transplant Rejection and Kidney Transplant Failure, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The present study aims to evaluate the usefulness of protocol biopsies in a cohort of renal transplant patients of high immunological risk for graft injury and loss. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Transplant Rejection, Kidney Transplant Failure, Kidney Transplant Infection
- What is being tested?
- Percutaneous renal biopsy.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2020to 28 Feb 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult kidney transplants, with high immunological risk, who consented to participate in the study by signing the informed consent form. The high immune risk is defined by:
- Positive pre-transplant T-lymphocyte cross-test by flow cytometry (channel deviation greater than 62);
- Flow cytometry pre-transplantation positive B lymphocyte cross-test (channel deviation greater than 112);
- Calculated panel reactivity greater than 50% in class I and / or class II;
- Presence in the pre-transplantation serum of donor class I and / or II anti-Human Leukocyte Antigen antibodies with intensity and fluorescence greater than 1000;
- Occurrence of cellular or antibody-mediated rejection within 30 days prior to the date of the protocol biopsy.
Who cannot join
- Patients with contraindication to renal graft biopsy;
- Patients whose biopsy fragments are not representative;
- Patients with graft dysfunction in whom renal graft biopsy is indicated within 4 weeks prior to protocol biopsy.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clinicas of Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-003
About this study
Official title: Utility Evaluation of Protocolar Renal Transplant Biopsies in High Risk Patients for Immunological Loss of Graft
The present study aims to evaluate the usefulness of protocol biopsies in a cohort of renal transplant patients of high immunological risk for graft injury and loss.
Read the detailed description
This will be a prospective study undertaken at the Renal Transplant Unit of Hospital of Clinics of Porto Alegre. In addition to the routine evaluation commonly carried-out at this post-transplant period, protocol biopsies will be performed at the 10th-week post-transplantation in high-risk transplant recipients. Biopsy fragments will be evaluated for tissue immune aggression (mainly cellular and antibody-mediated rejections) and other conditions such as infections, particularly polyomavirus and cytomegalovirus and medication toxicities. The presence of donor-specific antibodies and graft-damaging infectious agents will also be searched in the peripheral blood at the time of biopsy.One hundred patients will be randomized to a protocol biopsy and noninvasive assessment or only for noninvasive assessment. The hypothesis of the study is that biopsies will lead to treatments that may allow better outcomes of renal transplants, related to lowering the progression of subclinical aggressions, avoiding or delaying graft loss and preserving or decreasing the rate of loss of the glomerular filtration rate. Therefore, this strategy has the possibility of reaching clinical practice routine and thus contribute positively to the management of renal transplant patients.
- Conditions
- Kidney Transplant Rejection, Kidney Transplant Failure, Kidney Transplant Infection, Kidney Transplant Failure and Rejection
- Being tested
- Percutaneous renal biopsy.
- Keywords
- Kidney Transplantation, Protocol Biopsies, Kidney Transplant Rejection
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous renal biopsy.Procedure or surgery
The biopsy will be performed with a 16 Gauge semi-automatic needle gun for renal biopsy under real-time ultrasound control. After the procedure will be done ultrasound control
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | In addition to the routine evaluation commonly carried-out at this post-transplant period, protocol biopsies will be performed at the 10th-week post-transplantation in high-risk transplant recipients. Biopsy fragments will be evaluated for tissue immune aggression (mainly cellular and antibody-mediated rejections) and other conditions such as infections, particularly polyomavirus and cytomegalovirus and medication toxicities. Receives: Procedure: Percutaneous renal biopsy. |
| Control | No intervention | Patients will only undergo routine noninvasive evaluation at this post-transplant period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of rejection.
To evaluate the incidence of subclinical, cellular and antibody-mediated rejections in protocol biopsies performed on patients at high immune risk who underwent kidney transplantation.
Measured: Three months post transplant.
Secondary outcomes (1)
Graft survival
Comparison of glomerular filtration rate at 2 years after transplantation between groups of patients with and without protocol biopsy using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
Measured: Two years post transplant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start1 Feb 2020
- Primary completion15 Dec 2023 (estimated)
- Study completion28 Feb 2024 (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 Hospital de Clinicas de Porto AlegreThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will include 100 patients in this work. In the first 48 hours after transplantation 50 patients will be randomized in the protocol biopsy and noninvasive evaluation group and 50 patients for noninvasive evaluation only.
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roberto Ceratti Manfro, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04154267
- Sponsor's protocol ID
- 20180625
- Status last verified
- Jun 2023
- First submitted
- 21 Oct 2019
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- 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 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility Evaluation of Protocolar Renal Transplant Biopsies in High Risk Patients for Immunological Loss of Graft
- ClinicalTrials.gov ID
- NCT04154267
- Acronym / sponsor ID
- 20180625
- Conditions
- Kidney Transplant Rejection, Kidney Transplant Failure, Kidney Transplant Infection, Kidney Transplant Failure and Rejection
- Keywords
- Kidney Transplantation, Protocol Biopsies, Kidney Transplant Rejection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 6 Nov 2019 (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 present study aims to evaluate the usefulness of protocol biopsies in a cohort of renal transplant patients of high immunological risk for graft injury and loss.
Detailed description
This will be a prospective study undertaken at the Renal Transplant Unit of Hospital of Clinics of Porto Alegre. In addition to the routine evaluation commonly carried-out at this post-transplant period, protocol biopsies will be performed at the 10th-week post-transplantation in high-risk transplant recipients. Biopsy fragments will be evaluated for tissue immune aggression (mainly cellular and antibody-mediated rejections) and other conditions such as infections, particularly polyomavirus and cytomegalovirus and medication toxicities. The presence of donor-specific antibodies and graft-damaging infectious agents will also be searched in the peripheral blood at the time of biopsy.One hundred patients will be randomized to a protocol biopsy and noninvasive assessment or only for noninvasive assessment. The hypothesis of the study is that biopsies will lead to treatments that may allow better outcomes of renal transplants, related to lowering the progression of subclinical aggressions, avoiding or delaying graft loss and preserving or decreasing the rate of loss of the glomerular filtration rate. Therefore, this strategy has the possibility of reaching clinical practice routine and thus contribute positively to the management of renal transplant patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We will include 100 patients in this work. In the first 48 hours after transplantation 50 patients will be randomized in the protocol biopsy and noninvasive evaluation group and 50 patients for noninvasive evaluation only.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Percutaneous renal biopsy.In addition to the routine evaluation commonly carried-out at this post-transplant period, protocol biopsies will be performed at the 10th-week post-transplantation in high-risk transplant recipients. Biopsy fragments will be evaluated for tissue immune aggression (mainly cellular and antibody-mediated rejections) and other conditions such as infections, particularly polyomavirus and cytomegalovirus and medication toxicities. |
| Control | No intervention | –Patients will only undergo routine noninvasive evaluation at this post-transplant period |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Adult kidney transplants, with high immunological risk, who consented to participate in the study by signing the informed consent form. The high immune risk is defined by:
- Positive pre-transplant T-lymphocyte cross-test by flow cytometry (channel deviation greater than 62);
- Flow cytometry pre-transplantation positive B lymphocyte cross-test (channel deviation greater than 112);
- Calculated panel reactivity greater than 50% in class I and / or class II;
- Presence in the pre-transplantation serum of donor class I and / or II anti-Human Leukocyte Antigen antibodies with intensity and fluorescence greater than 1000;
Key exclusion criteria (3 listed)
- Patients with contraindication to renal graft biopsy;
- Patients whose biopsy fragments are not representative;
- Patients with graft dysfunction in whom renal graft biopsy is indicated within 4 weeks prior to protocol biopsy.
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 |
|---|---|---|
| Percutaneous renal biopsy.The biopsy will be performed with a 16 Gauge semi-automatic needle gun for renal biopsy under real-time ultrasound control. After the procedure will be done ultrasound control | Procedure or surgery | Intervention |
Primary outcome
Incidence of rejection.
Time frame: Three months post transplant.
To evaluate the incidence of subclinical, cellular and antibody-mediated rejections in protocol biopsies performed on patients at high immune risk who underwent kidney transplantation.
1 secondary outcome
Graft survival
Time frame: Two years post transplant.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- 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.
Roberto Ceratti Manfro, PhD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous renal biopsy. in people with Kidney Transplant Rejection and Kidney Transplant Failure, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 6 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: status not confirmed, as of the sponsor's last update on 28 Jun 2023. 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 Brazil. 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?
Incidence of rejection. (time frame: Three months post transplant.). 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 Jun 2023.