Kidney Transplant Failure and RejectionBIOTRAIMNCT05816486
BIOtechnology Applied to Renal TRansplantation With IMmunobiogram
An observational study of Kidney Transplant Failure and Rejection, run by Biohope Scientific Solutions for Human Health, S.L. at 15 sites in 5 countries.
Trial summary
Immunobiogram (IMBG) is a novel in vitro diagnostic bioassay developed by Biohope Scientific Solutions for Human Health SL, that allows to measure the pharmacodynamic response to individual immunosuppressive drugs in patients with a renal transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Failure and Rejection
- What is being tested?
- Immunobiogram
- How many people
- 443 participants
- Where
- 15 sitesin 5 countries
- Study dates
- 1 Mar 2022to 30 Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Prospective longitudinal cohort: all patients who are to receive a kidney transplant and meet the screening criteria for this study cohort. This cohort will be recruited in sites that routinely perform a Protocol Biopsy (PB) one year after transplant. 2. Cross-sectional cohort: patients in whom an Indication Biopsy (IB) is to be performed due to suspicion of rejection. This cohort may be recruited in all sites participating in the study and patients will be enrolled competitively. 3. Control cohort: cross-sectional cohort to include patients who have received a kidney transplant or a re-transplant less than 5 years before inclusion in the study and have shown a stable clinical course after 6 months post-transplant. An IMBG will be performed coinciding with the study visit.
Who may be able to join
- Longitudinal cohort:
- Patients > 18 years of age.
- Candidate to receive a kidney transplant or re-transplant.
- Patients in whom it is planned to routinely perform a protocol biopsy one year after the kidney transplant for which there is no contraindication at the time of inclusion in the study.
- Patients in whom a pre-transplant blood sample can be drawn that is viable for the processing of an IMBG.
- Patients who give their written informed consent to participate in the study.
Show all 32Show fewer
- Cross-sectional cohort:
- Patients > 18 years of age.
- Patients who have received a kidney transplant or re-transplant less than 3 years before inclusion in the study.
- Patients in whom an indication biopsy is to be performed due to suspicion of rejection.
- Patients in whom a blood sample can be drawn in a period of time less than 8 days before or after the Indication Biopsy that is viable for the processing of an IMBG.
- Patients who give their written informed consent to participate in the study.
- Exclusion Criteria (PROSPECTIVE AND CROSS-SECTIONAL COHORT):
- Patient with a double transplant (kidney + other organ).
- Contraindication for performing a renal graft biopsy.
- Active autoimmune diseases in the 12 months prior to the study visit (with systemic inflammatory exacerbation in the year prior to study inclusion, despite immunosuppressive therapy).
- Very elderly cadaver donor transplant (>80 years of age).
- Donors in asystole II.
- Recurrent primary kidney disease in the case of primary focal and segmental hyalinosis or hemolytic-uremic syndrome.
- Active HIV, HBV or HCV infection or other severe infections (to prevent risks in the processing of samples in conventional laboratories).
- Concomitant medical conditions that may affect the patient's participation in the study.
- Control cohort:
- Patients > 18 years of age.
- Patients who have received a kidney transplant or re-transplant less than 5 years before inclusion in the study.
- A stable course after 6 months post-transplant defined as:
- Lack of renal impairment (GFR > 50 ml/min/1.73 m2 and proteinuria < 300 mg/g)
- No previous rejection episodes and no graft indication biopsies
- No positive dnDSA
- No change in the active principle of immunosuppressive drugs in the last 6 weeks
- No opportunistic infections in the last 6 months
- Patients in whom a blood sample can be drawn suitable for IMBG processing.
- Patients (or their legal representative) who give their written informed consent to participate in the study.
Who cannot join
- Patient with a double transplant (kidney + other organ).
- Active autoimmune diseases in the 12 months prior to the study visit (with systemic inflammatory exacerbation in the year prior to study inclusion, despite immunosuppressive therapy).
- Very elderly cadaver donor transplant (>80 years of age).
- Donors in asystole II.
- Recurrent primary kidney disease in the case of primary focal and segmental hyalinosis or hemolytic-uremic syndrome.
- Active HIV, HBV or HCV infection or other severe infections (to prevent risks in the processing of samples in conventional laboratories).
- Concomitant medical conditions that may affect the patient's participation in the study.
Trial locations and contacts
15 sites in 5 countries.
15 sites in 5 countries
Spain10 sites
Fundació Puigvert
Barcelona
Hospital Clínic de Barcelona
Barcelona
Hospital del Mar
Barcelona
Hospital Universitario Puerta del Mar
Cadiz
Hospital Clínico San Carlos
Madrid
Hospital Universitario 12 Octubre
Madrid
Hospital Universitario La Paz
Madrid
Hospital Universitario Puerta de Hierro
Madrid
Hospital Universitario Marqués de Valdecilla
Santander
Hospital Universitario Dr. Peset
Valencia
Germany2 sites
Charité Universitätsmedizin Berlin
Berlin
Universitätsklinikum Heidelberg
Heidelberg
About this study
Official title: Longitudinal Observational Study to Determine the Correlation Between Patient's Pharmacodynamic Response to Immunosuppressants Measured in Vitro With IMMUNOBIOGRAM and of Rejection in Graft Biopsies in Patients With Renal Transplantation
Immunobiogram (IMBG) is a novel in vitro diagnostic bioassay developed by Biohope Scientific Solutions for Human Health SL, that allows to measure the pharmacodynamic response to individual immunosuppressive drugs in patients with a renal transplantation. Pharmacodynamics can complement the already available pharmacokinetic information on immunosuppressants and enable a more individualized evaluation of the immunosuppressive therapy.
The aim of this study is to evaluate the association between the pharmacodynamic response to individual immunosuppressants taken by the patient measured in vitro with IMBG and the existence of signs of graft rejection in biopsies (upon indication or protocol) performed in a sample of kidney transplant patients.
The main hypothesis is that a lower sensitivity to the immunosuppressive drugs taken by the patient will be associated with a higher probability of rejection.
Read the detailed description
Immunobiogram (IMBG) is a novel bioassay that allows to measure in vitro the inhibitory effect of a battery of individual immunosuppressants on the patient's immune cells (immunologically stimulated PBMCs).
Studies conducted in kidney transplant patients have shown that IMBG is a valid and accurate instrument, capable of determining each patient's pharmacodynamic response profile to individual immunosuppressive drugs.
Health professionals who monitor kidney transplant patients currently have information only on immunosuppressant pharmacokinetics to adjust the regimen of the immunosuppressants they use to treat the patients to avoid graft rejection. The pharmacodynamic measurement of the in vitro effect of each immunosuppressant in the patient could complement the pharmacokinetic information and enable more personalized approaches.
The main objective of this study is to evaluate the association between the pharmacodynamic response to individual immunosuppressants taken by the patient measured with IMBG and the existence of signs of graft rejection in biopsies (upon indication or protocol) performed in a sample of kidney transplant patients.
A longitudinal follow-up cohort of patients will be recruited from prior to the transplant (at sites that regularly perform a protocol graft biopsy after a year) and a cross-sectional cohort of patients will also be included when an indication biopsy is performed during the first five years after kidney transplantation due to a suspicion of rejection at sites that do not routinely perform protocol biopsies.
Given that one of the main challenges that clinicians face in the follow-up of patients is to reduce the risk of renal graft rejection, while minimizing the incidence of secondary effects related to immunosuppressive therapy, it is proposed as a secondary objective to evaluate in the longitudinal cohort the incidence of "therapeutical failure" due to graft failure or due to the appearance of serious adverse effects attributable to immunosuppression and analyze its relationship with the profile of sensitivity to immunosuppressants taken by the patient measured with IMBG.
It will be also evaluated if the IMBG sensitivity to immunosuppressive drugs measured pretransplant predict the ocurrence of rejection or adverse events during the first year postransplant.
Finally, the changes over time presented by the IMBG in various determinations and the correlation between IMBG results and other lymphocyte activation parameters obtained by flow cytometry will be analyzed.
- Conditions
- Kidney Transplant Failure and Rejection
- Being tested
- Immunobiogram
- Keywords
- Kidney Transplant Rejection, Immunosuppression, Immune cell bioassay, Pharmacodynamics, Oportunistic infections
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunobiogramDiagnostic test
This is not an interventional study. However the assay being tested on the blood samples of all enrolled participants is the Immunobiogram (IMBG). IMBG is an in vitro diagnostic immunoassay which can obtain dose-response curves that describe the inhibitory effect of each immunosuppressant on immune response cells (immunologically stimulated PBMCs) in kidney transplant patients.
| Study group | Role | What they receive |
|---|---|---|
| Prospective - Longitudinal | Longitudinal follow-up cohort in which all patients who are going to receive a kidney transplant and meet the selection criteria for this study cohort will be included. This cohort will be recruited at sites that routinely perform Protocol Biopsies (PB) one year after transplant. A pre-transplant and post-transplant follow-up IMBG at 3, 6, 9 and 12 months will be performed, and additional IMBG will be carried out when an indication biopsy is required due to a suspected rejection during the patients' follow-up. A protocol biopsy will be performed after one year of follow-up of the patients. Receives: Diagnostic Test: Immunobiogram | |
| Cross-sectional | Patients in whom an Indication Biopsy (IB) is to be performed due to suspicion of rejection. This cohort may be recruited in all sites participating in the study, including sites where annual protocol biopsies are not routinely performed. An IMBG will be performed coinciding with the IB. This cohort will include patients who have had their transplant for less than 5 years. Receives: Diagnostic Test: Immunobiogram | |
| Control | Patients who have received a kidney transplant or a re-transplant less than 5 years before inclusion in the study and have shown a stable clinical course after 6 months from the RT, defined as: patients without previous rejection episodes nor indication biopsies, who do not show signs of renal impairment and are dnDSA negative, without changes in immunosuppressive drugs in the last 6 weeks and without opportunistic infections in the last six months before entering in the study. An IMBG will be performed coinciding with the only visit. Receives: Diagnostic Test: Immunobiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with BPAR in biopsies (following BANFF 2019 criteria) who present Low Sensitivity to the prescribed Immunosupressive drugs in IMBG
Proportion of patients with BPAR (BANFF 2019 2, 3 or 4) who present Low Sensitivity to the prescribed Immunosupressive drugs in IMBG in longitudinal cohort in 1 year- Protocol Biopsies or in Indication Biopsies and in the cross sectional cohort in Indication Biopsies
Measured: 12 months in the prospective follow-up cohort.
Secondary outcomes (9)
Proportion of patients with impairment in renal function AND BPAR or inflammatory damage in biopsies or the presence of dnDSA in the last determination who present low sensitivity to the individual immunosuppressive drugs in IMBG
Proportion of patients with impairment in renal function AND signs of rejection (BPAR) or inflammatory damage in protocol/indication biopsies or the presence of de novo antidonor specific antibodies (dnDSA) in the last determination prior to the biopsy who present low sensitivity to individual prescribed immunosuppressive drugs in IMBG
Measured: 12 months
Proportion of patients with impairment in renal function AND BPAR or inflammatory damage in biopsies or the presence of dnDSA in the last determination who present low sensitivity to all prescribed immunosuppressive drugs in IMBG
Proportion of patients with impairment in renal function AND signs of rejection (BPAR) or inflammatory damage in protocol/indication biopsies or the presence of de novo antidonor specific antibodies (dnDSA) in the last determination prior to the biopsy who present low sensitivity to all prescribed immunosuppressive drugs in IMBG
Measured: 12 months
Proportion of patients with therapeutical failure due to rejection who present low sensitivity to the prescribed immunosuppressive drugs in IMBG
Proportion of patients with therapeutical failure due to rejection who present low sensitivity to the prescribed immunosuppressive drugs in IMBG (Therapeutical failure is defined as the incidence of graft loss and/or BPAR and/or dnDSA)
Measured: 12 months in the prospective follow-up cohort.
Proportion of patients with with therapeutical failure due adverse effects attributable to immunosuppression who present high sensitivity /or low sensitivity and high doses to the prescribed immunosuppressive drugs in IMBG
Proportion of patients with therapeutical failure due adverse effects attributable to immunosuppression who present high sensitivity /or low sensitivity and high doses to the prescribed immunosuppressive drugs in IMBG Therapeutical failure is defined as the incidence of opportunistic infection by Cytomegalovirus (CMV) (symptomatic or not) and/or BK polyomavirus (BKV) and/or 3 or more hospitalizations due to infections during the patient's follow-up).
Measured: 12 months in the prospective follow-up cohort.
Proportion of patients whose pre-transplant IMBG predicts the incidence of events during the patients' follow up
Proportion of patients whose pre-transplant IMBG predicts the incidence of events (graft rejection failure or failure due to adverse effects attributable to immunosuppression) during the patients' follow up
Measured: 12 months
Correlation between IMBG values and other lymphocyte activation markers
Correlation between IMBG values and other lymphocyte activation markers (CD69, CD25) for each immunosuppressive drug tested with IMBG over time
Measured: In the prospective cohort at 3, 6, 9, and 12 months
Distribution of pre-transplant IMBG values and post-transplant at 3, 6, 9, and 12 months
Distribution of pre-transplant IMBG values and post-transplant at 3, 6, 9, and 12 months
Measured: In the prospective cohort at 3, 6 , 9 and 12 months
Adherence to treatment measured with Morisky Green Scale (MMAS).
Adherence to treatment measured with Morisky Green Scale (MMAS, score 0 (worst adherence) - 4 (best adherence), at 6 months and at one year.
Measured: at 6 and at 12 months
Quality of Life perceived by the patient, measured with EQ-5D-5L questionnaire.
Quality of Life perceived by the patient, measured with European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) questionnaire (score 0 (worst health) - 100 (best health) at baseline and at one year.
Measured: baseline and at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Mar 2022
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplant Failure and RejectionStudies 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
- Prospective
- Enrolment
- 443 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biohope Scientific Solutions for Human Health, S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Isabel Portero, Study chair, Biohope Scientific Solutions for Human Health, S.L.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05816486
- Sponsor's protocol ID
- BH-IMBG-TR-2021
- Acronym
- BIOTRAIM
- Status last verified
- Jul 2024
- First submitted
- 9 Feb 2023
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Portoles JM, Jimenez C, Janeiro D, Lopez-Oliva MO, Ortega-Carrion A, Blanquez D, Arribas L, Gomez C, Diez T, Pascual J, Portero I. The Immunobiogram, a Novel In Vitro Assay to Evaluate Treatment Resistance in Patients Receiving Immunosuppressive Therapy. Front Immunol. 2021 Jan 25;11:618202. doi: 10.3389/fimmu.2020.618202. eCollection 2020.
PubMed 33569062Pascual J, Jimenez C, Krajewska M, Seron D, Kotton CN, Portoles J, Witzke O, Sorensen SS, Andres A, Crespo M, Paz-Artal E, Diez T, Ortega A, Portero I. The Immunobiogram, a novel in vitro diagnostic test to measure the pharmacodynamic response to immunosuppressive therapy in kidney transplant patients. Transpl Immunol. 2022 Dec;75:101711. doi: 10.1016/j.trim.2022.101711. Epub 2022 Sep 9.
PubMed 36096417Pascual J, Crespo M, Portoles J, Jimenez C, Ortega-Carrion A, Diez T, Portero I. The IMBG Test for Evaluating the Pharmacodynamic Response to Immunosuppressive Therapy in Kidney Transplant Patients: Current Evidence and Future Applications. Int J Mol Sci. 2023 Mar 8;24(6):5201. doi: 10.3390/ijms24065201.
PubMed 36982276
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Observational Study to Determine the Correlation Between Patient's Pharmacodynamic Response to Immunosuppressants Measured in Vitro With IMMUNOBIOGRAM and of Rejection in Graft Biopsies in Patients With Renal Transplantation
- ClinicalTrials.gov ID
- NCT05816486
- Acronym / sponsor ID
- BIOTRAIM / BH-IMBG-TR-2021
- Conditions
- Kidney Transplant Failure and Rejection
- Keywords
- Kidney Transplant Rejection, Immunosuppression, Immune cell bioassay, Pharmacodynamics, Oportunistic infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 443 participants (actual)
- Lead sponsor
- Biohope Scientific Solutions for Human Health, S.L.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 18 Apr 2023 (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.
Immunobiogram (IMBG) is a novel in vitro diagnostic bioassay developed by Biohope Scientific Solutions for Human Health SL, that allows to measure the pharmacodynamic response to individual immunosuppressive drugs in patients with a renal transplantation. Pharmacodynamics can complement the already available pharmacokinetic information on immunosuppressants and enable a more individualized evaluation of the immunosuppressive therapy.
The aim of this study is to evaluate the association between the pharmacodynamic response to individual immunosuppressants taken by the patient measured in vitro with IMBG and the existence of signs of graft rejection in biopsies (upon indication or protocol) performed in a sample of kidney transplant patients.
The main hypothesis is that a lower sensitivity to the immunosuppressive drugs taken by the patient will be associated with a higher probability of rejection.
Detailed description
Immunobiogram (IMBG) is a novel bioassay that allows to measure in vitro the inhibitory effect of a battery of individual immunosuppressants on the patient's immune cells (immunologically stimulated PBMCs).
Studies conducted in kidney transplant patients have shown that IMBG is a valid and accurate instrument, capable of determining each patient's pharmacodynamic response profile to individual immunosuppressive drugs.
Health professionals who monitor kidney transplant patients currently have information only on immunosuppressant pharmacokinetics to adjust the regimen of the immunosuppressants they use to treat the patients to avoid graft rejection. The pharmacodynamic measurement of the in vitro effect of each immunosuppressant in the patient could complement the pharmacokinetic information and enable more personalized approaches.
The main objective of this study is to evaluate the association between the pharmacodynamic response to individual immunosuppressants taken by the patient measured with IMBG and the existence of signs of graft rejection in biopsies (upon indication or protocol) performed in a sample of kidney transplant patients.
A longitudinal follow-up cohort of patients will be recruited from prior to the transplant (at sites that regularly perform a protocol graft biopsy after a year) and a cross-sectional cohort of patients will also be included when an indication biopsy is performed during the first five years after kidney transplantation due to a suspicion of rejection at sites that do not routinely perform protocol biopsies.
Given that one of the main challenges that clinicians face in the follow-up of patients is to reduce the risk of renal graft rejection, while minimizing the incidence of secondary effects related to immunosuppressive therapy, it is proposed as a secondary objective to evaluate in the longitudinal cohort the incidence of "therapeutical failure" due to graft failure or due to the appearance of serious adverse effects attributable to immunosuppression and analyze its relationship with the profile of sensitivity to immunosuppressants taken by the patient measured with IMBG.
It will be also evaluated if the IMBG sensitivity to immunosuppressive drugs measured pretransplant predict the ocurrence of rejection or adverse events during the first year postransplant.
Finally, the changes over time presented by the IMBG in various determinations and the correlation between IMBG results and other lymphocyte activation parameters obtained by flow cytometry will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prospective - Longitudinal | – | Diagnostic Test: ImmunobiogramLongitudinal follow-up cohort in which all patients who are going to receive a kidney transplant and meet the selection criteria for this study cohort will be included. This cohort will be recruited at sites that routinely perform Protocol Biopsies (PB) one year after transplant. A pre-transplant and post-transplant follow-up IMBG at 3, 6, 9 and 12 months will be performed, and additional IMBG will be carried out when an indication biopsy is required due to a suspected rejection during the patients' follow-up. A protocol biopsy will be performed after one year of follow-up of the patients. |
| Cross-sectional | – | Diagnostic Test: ImmunobiogramPatients in whom an Indication Biopsy (IB) is to be performed due to suspicion of rejection. This cohort may be recruited in all sites participating in the study, including sites where annual protocol biopsies are not routinely performed. An IMBG will be performed coinciding with the IB. This cohort will include patients who have had their transplant for less than 5 years. |
| Control | – | Diagnostic Test: ImmunobiogramPatients who have received a kidney transplant or a re-transplant less than 5 years before inclusion in the study and have shown a stable clinical course after 6 months from the RT, defined as: patients without previous rejection episodes nor indication biopsies, who do not show signs of renal impairment and are dnDSA negative, without changes in immunosuppressive drugs in the last 6 weeks and without opportunistic infections in the last six months before entering in the study. An IMBG will be performed coinciding with the only visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Prospective longitudinal cohort: all patients who are to receive a kidney transplant and meet the screening criteria for this study cohort. This cohort will be recruited in sites that routinely perform a Protocol Biopsy (PB) one year after transplant. 2. Cross-sectional cohort: patients in whom an Indication Biopsy (IB) is to be performed due to suspicion of rejection. This cohort may be recruited in all sites participating in the study and patients will be enrolled competitively. 3. Control cohort: cross-sectional cohort to include patients who have received a kidney transplant or a re-transplant less than 5 years before inclusion in the study and have shown a stable clinical course after 6 months post-transplant. An IMBG will be performed coinciding with the study visit.
Key inclusion criteria (32 listed)
- Patients > 18 years of age.
- Candidate to receive a kidney transplant or re-transplant.
- Patients in whom it is planned to routinely perform a protocol biopsy one year after the kidney transplant for which there is no contraindication at the time of inclusion in the study.
- Patients in whom a pre-transplant blood sample can be drawn that is viable for the processing of an IMBG.
- Patients who give their written informed consent to participate in the study.
Key exclusion criteria (7 listed)
- Patient with a double transplant (kidney + other organ).
- Active autoimmune diseases in the 12 months prior to the study visit (with systemic inflammatory exacerbation in the year prior to study inclusion, despite immunosuppressive therapy).
- Very elderly cadaver donor transplant (>80 years of age).
- Donors in asystole II.
- Recurrent primary kidney disease in the case of primary focal and segmental hyalinosis or hemolytic-uremic syndrome.
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 |
|---|---|---|
| ImmunobiogramThis is not an interventional study. However the assay being tested on the blood samples of all enrolled participants is the Immunobiogram (IMBG). IMBG is an in vitro diagnostic immunoassay which can obtain dose-response curves that describe the inhibitory effect of each immunosuppressant on immune response cells (immunologically stimulated PBMCs) in kidney transplant patients. | Diagnostic test | Control, Cross-sectional, Prospective - Longitudinal |
Primary outcome
Proportion of patients with BPAR in biopsies (following BANFF 2019 criteria) who present Low Sensitivity to the prescribed Immunosupressive drugs in IMBG
Time frame: 12 months in the prospective follow-up cohort.
Proportion of patients with BPAR (BANFF 2019 2, 3 or 4) who present Low Sensitivity to the prescribed Immunosupressive drugs in IMBG in longitudinal cohort in 1 year- Protocol Biopsies or in Indication Biopsies and in the cross sectional cohort in Indication Biopsies
9 secondary outcomes
Proportion of patients with impairment in renal function AND BPAR or inflammatory damage in biopsies or the presence of dnDSA in the last determination who present low sensitivity to the individual immunosuppressive drugs in IMBG
Time frame: 12 months
Proportion of patients with impairment in renal function AND BPAR or inflammatory damage in biopsies or the presence of dnDSA in the last determination who present low sensitivity to all prescribed immunosuppressive drugs in IMBG
Time frame: 12 months
Proportion of patients with therapeutical failure due to rejection who present low sensitivity to the prescribed immunosuppressive drugs in IMBG
Time frame: 12 months in the prospective follow-up cohort.
Proportion of patients with with therapeutical failure due adverse effects attributable to immunosuppression who present high sensitivity /or low sensitivity and high doses to the prescribed immunosuppressive drugs in IMBG
Time frame: 12 months in the prospective follow-up cohort.
Proportion of patients whose pre-transplant IMBG predicts the incidence of events during the patients' follow up
Time frame: 12 months
Correlation between IMBG values and other lymphocyte activation markers
Time frame: In the prospective cohort at 3, 6, 9, and 12 months
Distribution of pre-transplant IMBG values and post-transplant at 3, 6, 9, and 12 months
Time frame: In the prospective cohort at 3, 6 , 9 and 12 months
Adherence to treatment measured with Morisky Green Scale (MMAS).
Time frame: at 6 and at 12 months
Quality of Life perceived by the patient, measured with EQ-5D-5L questionnaire.
Time frame: baseline and at 12 months
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 18 Jul 2024.
- Background: PubMed 33569062Portoles JM, Jimenez C, Janeiro D, Lopez-Oliva MO, Ortega-Carrion A, Blanquez D, Arribas L, Gomez C, Diez T, Pascual J, Portero I. The Immunobiogram, a Novel In Vitro Assay to Evaluate Treatment Resistance in Patients Receiving Immunosuppressive Therapy. Front Immunol. 2021 Jan 25;11:618202. doi: 10.3389/fimmu.2020.618202. eCollection 2020.
- Background: PubMed 36096417Pascual J, Jimenez C, Krajewska M, Seron D, Kotton CN, Portoles J, Witzke O, Sorensen SS, Andres A, Crespo M, Paz-Artal E, Diez T, Ortega A, Portero I. The Immunobiogram, a novel in vitro diagnostic test to measure the pharmacodynamic response to immunosuppressive therapy in kidney transplant patients. Transpl Immunol. 2022 Dec;75:101711. doi: 10.1016/j.trim.2022.101711. Epub 2022 Sep 9.
- Background: PubMed 36982276Pascual J, Crespo M, Portoles J, Jimenez C, Ortega-Carrion A, Diez T, Portero I. The IMBG Test for Evaluating the Pharmacodynamic Response to Immunosuppressive Therapy in Kidney Transplant Patients: Current Evidence and Future Applications. Int J Mol Sci. 2023 Mar 8;24(6):5201. doi: 10.3390/ijms24065201.
- Biohope Scientific Solutions for Human Health, S.L.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Kidney Transplant Failure and Rejection
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
Not yet recruitingPhase 2
(TNX-1500) in Kidney Transplant Recipients
Kidney Transplant, Kidney Transplant Failure and Rejection
RecruitingPhase 2
A Study Comparing Siplizumab With Rabbit Anti-Thymocyte Globulin to Help the Body Accept a Kidney Transplant
Renal Transplant Failure and Rejection
Not yet recruitingPhase 1
ECP-DL Cell Infusion for Induction in Living Donor Kidney (LDK) Transplants
Kidney Transplant Failure and Rejection, Kidney Transplant; Complications
Not yet recruitingObservational study
Microbiota Changes Related to Outcomes in Kidney Transplantation
End-stage Renal Disease (ESRD), Kidney Transplantation
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.
Isabel Portero study chair
Biohope Scientific Solutions for Human Health, S.L.
15 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant Failure and Rejection, run by Biohope Scientific Solutions for Human Health, S.L. at 15 sites in 5 countries.
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 32 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 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Spain, Germany, Brazil, France, Sweden. 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?
Proportion of patients with BPAR in biopsies (following BANFF 2019 criteria) who present Low Sensitivity to the prescribed Immunosupressive drugs in IMBG (time frame: 12 months in the prospective follow-up cohort.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05816486, which also lists 3 linked publications.
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 18 Jul 2024.