Kidney TransplantationTRANSBIONCT03562845
Evaluation of Immunobiogram® as a Tool in Adjustment of Immunosuppressant Therapy for Renal Transplant
An observational study of Kidney Transplantation, run by Biohope Scientific Solutions for Human Health, S.L. at 1 site in United States.
Trial summary
The trial is an observational, multi-center study to determine if a new blood test (Immunobiogram®) done after renal transplant can help predict how well the immune system is working and responding to a new kidney. Read more about this study
- Who is it for?
- Ages 25 to 69 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- NA-Observational only
- How many people
- 164 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 31 May 2019
- 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 25 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female subjects <25 to < 70 years in age who have had a renal transplant performed at least one year before inclusion in the study
Who may be able to join
- Age > 25 years and < 70 years.
- Male and Female.
- Renal transplant performed at least 1 year before inclusion.
- ARM 1:
- Bad clinical evolution: patients with renal dysfunction and positive biopsy to rejection OR significant increase in strength of DSA expressed as Luminex MFI. Specifically, the following two criteria must comply:
- Renal function progressive deterioration, with significant creatinine increase of at least 15% for 18 months and/or proteinuria over > 500 mg/day or ratio protein/creatinine> 500 mg/g DE NOVO or increase in 50%.
Show all 17Show fewer
- Biopsy in the last 12 months that shows positive signs attributable to any kind of immunological response compatible with any type of rejection AND/OR at least 50% increase in strength of DSA expressed as Luminex MFI in comparison with previous determination and always at titers more than 3000UI.
- Good clinical evolution: patients without rejection episodes, negative DSA, stable renal function and no changes in treatment in the past 12 months. ALL the following criteria must apply
- Stable renal function in the past 12 months
- NO DSA titers
- No history of previous rejection episodes
- Stable immunosuppressive medication (No change in prednisone or MPA dose and tacrolimus dose with changes <20% of the dose) in the past 12 months
- ARM 2:
- Stable renal function
- No DSA titers
- No history of previous rejection episodes
- Stable immunosuppressive medication (No change in prednisone or MPA dose and tacrolimus dose with changes <20% of the dose) at least in the past 18 months
Who cannot join
- Rejection of informed consent
- Active systemic infections that needed antimicrobial treatment in the past two months
- Active immune-based diseases with acute outbreaks in the past 12 months, despite immunosuppressive treatment
- Severe ischemia-reperfusion injury of current renal transplant with delayed graft function objectively evident at more than 20 days after transplant AND/OR kidney transplanted from a deceased, very elderly donor (>80 years)
- Double transplant (renal + another organ)
- HIV, HBV, HCV infection or other severe infectious diseases that prevent blood samples from being processed in a conventional laboratory
- Chronic Allograft Injury (CAI) unlikely related to immune processes, by the Investigator´s judgement
- Recurrent primary kidney disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Evaluation of the Clinical Consistency and Analytical Robustness of Immunobiogram® as an In Vitro Diagnostics Biotechnological Tool to Help Decision-making in Adjustment of Immunosuppressant Therapy for Renal Transplant
The trial is an observational, multi-center study to determine if a new blood test (Immunobiogram®) done after renal transplant can help predict how well the immune system is working and responding to a new kidney. These blood tests could, in the future, potentially guide how doctors manage patient's anti-rejection medication.
Read the detailed description
Rejection in renal transplants is a major problem unsolved in the long term, as 30-50% of patients lose their kidney due to rejection, or rejection mechanisms are involved elsewhere. One of the presumed key factors that may deliver such bad outcomes is the difficulties to personalise immunosuppressive treatment; a medical need that currently relies on immunosuppressive levels for some medications (pharmacokinetics), clinical guideline recommendations, adverse events profiles and some expensive biomarkers which are not widely used. Immunobiogram® (IMBG) is a tool that evaluates the sensitivity/resistance profile of patients to each of the most widely used and representative immunosuppressant drugs (IM). Thus, IMBG offers information that could become pivotal in clinical management of renal transplanted patients, if its potential benefits are proven. In this clinical study, a technology validation will be performed in which the robustness of the bioassay will be evaluated; and a correlation between the current clinical prognoses of each patient and resistance patterns will be explored.
- Conditions
- Kidney Transplantation
- Being tested
- NA-Observational only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NA-Observational onlyOther
NA-Observational only
| Study group | Role | What they receive |
|---|---|---|
| ARM 1-Bad vs Good Clinical Evolution | This arm is intended to evaluate the correlation of Immunobiogram® sensitivity/resistance patterns with clinical prognosis as it may be judged at this moment considering clinical outcomes and immune-biomarker evolution in the past 12 to 18 months. Thus, it may confirm the BH-Pilot study findings. Renal transplant patients of two types will be included:
* Patients who, over previous months, have had a bad clinical evolution, in which rejection mechanisms were involved
* Patients with a good and stable clinical evolution
IMBG sensitivity/resistance profiles will be compared amongst the two groups to evaluate the differences. Receives: Other: NA-Observational only | |
| ARM 2-Stable Renal Transplant Patients | This arm is intended to evaluate robustness of Immunobiogram® as an IVD test. Thus, it will be performed intrasubject comparisons and inter-time evaluation of two sets of Immunobiogram® separated by 30+/- 10 days, each including three IMBG determinations (IMBGx3 - IMBGx3, the two sets separated by 30+/- 10 days). The intended evaluation will be to analyse the similarities between all IMBG tests performed, both between the same set and also between the two sets planned. Receives: Other: NA-Observational only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the robustness of Immunobiogram® (IMBG) as an in vitro Diagnostic Bioassay to study the sensitivity/resistance patterns of Immunosuppressant drugs in Renal Transplantation
Robustness of Immunobiogram® (IMBG) as an In Vitro Diagnostic Bioassay to study the sensitivity/resistance patterns of Immunosuppressant drugs in Renal Transplantation, evaluated as follows:
- Immunobiogram® offers personal sensitivity/resistance patterns of Immunosuppressive Medications (IM), with a range of responses for each IM drug considering all patients included
- Immunobiogram® shows intrasubject consistency in terms of similarity with a maximum +/- 20% of variation in the inhibitory dose/distance 50 (ID50), in the three IMBG performed on inclusion; and additionally, similar consistency must be observed in the last three IMBG performed one month after inclusion
Measured: Baseline and 30 days
Secondary outcomes (2)
Evaluate intrasubject and inter-time consistency of Immunobiogram®
Immunobiogram® shows intrasubject and inter-time consistency in terms of similarity with a maximum +/- 30% variation ID50, in the average response of the three IMBG performed on inclusion and the average response of the three IMBG performed one month after inclusion, provided that no significant clinical or immunological events happened during follow-up, as assessed with a specifically provided questionnaire and the Investigator´s judgement
Measured: Baseline and 30 days
Evaluate the correlation of Immunobiogram® sensitivity/resistance patterns with clinical evolution
ARM 1 describes the Immunobiogram® discrimination ranges based on the correlation with the results of sensitivity/resistance patterns to immunosuppressants as regards the trend of clinical progression in each patient.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start1 Jun 2018
- Primary completion30 Apr 2019
- Study completion31 May 2019
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.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 164 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
- Julio Pascual, MD, PhD, Principal investigator, Parc du Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03562845
- Sponsor's protocol ID
- BHP-IBG-2017-01
- Acronym
- TRANSBIO
- Status last verified
- Dec 2023
- First submitted
- 28 May 2018
- Last updated
- 29 Dec 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 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Consistency and Analytical Robustness of Immunobiogram® as an In Vitro Diagnostics Biotechnological Tool to Help Decision-making in Adjustment of Immunosuppressant Therapy for Renal Transplant
- ClinicalTrials.gov ID
- NCT03562845
- Acronym / sponsor ID
- TRANSBIO / BHP-IBG-2017-01
- Conditions
- Kidney Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Biohope Scientific Solutions for Human Health, S.L.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 20 Jun 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 trial is an observational, multi-center study to determine if a new blood test (Immunobiogram®) done after renal transplant can help predict how well the immune system is working and responding to a new kidney. These blood tests could, in the future, potentially guide how doctors manage patient's anti-rejection medication.
Detailed description
Rejection in renal transplants is a major problem unsolved in the long term, as 30-50% of patients lose their kidney due to rejection, or rejection mechanisms are involved elsewhere. One of the presumed key factors that may deliver such bad outcomes is the difficulties to personalise immunosuppressive treatment; a medical need that currently relies on immunosuppressive levels for some medications (pharmacokinetics), clinical guideline recommendations, adverse events profiles and some expensive biomarkers which are not widely used. Immunobiogram® (IMBG) is a tool that evaluates the sensitivity/resistance profile of patients to each of the most widely used and representative immunosuppressant drugs (IM). Thus, IMBG offers information that could become pivotal in clinical management of renal transplanted patients, if its potential benefits are proven. In this clinical study, a technology validation will be performed in which the robustness of the bioassay will be evaluated; and a correlation between the current clinical prognoses of each patient and resistance patterns will be explored.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM 1-Bad vs Good Clinical Evolution | – | Other: NA-Observational onlyThis arm is intended to evaluate the correlation of Immunobiogram® sensitivity/resistance patterns with clinical prognosis as it may be judged at this moment considering clinical outcomes and immune-biomarker evolution in the past 12 to 18 months. Thus, it may confirm the BH-Pilot study findings. Renal transplant patients of two types will be included: * Patients who, over previous months, have had a bad clinical evolution, in which rejection mechanisms were involved * Patients with a good and stable clinical evolution IMBG sensitivity/resistance profiles will be compared amongst the two groups to evaluate the differences. |
| ARM 2-Stable Renal Transplant Patients | – | Other: NA-Observational onlyThis arm is intended to evaluate robustness of Immunobiogram® as an IVD test. Thus, it will be performed intrasubject comparisons and inter-time evaluation of two sets of Immunobiogram® separated by 30+/- 10 days, each including three IMBG determinations (IMBGx3 - IMBGx3, the two sets separated by 30+/- 10 days). The intended evaluation will be to analyse the similarities between all IMBG tests performed, both between the same set and also between the two sets planned. |
Who may qualify
- Ages
- 25 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female subjects <25 to < 70 years in age who have had a renal transplant performed at least one year before inclusion in the study
Key inclusion criteria (17 listed)
- Age > 25 years and < 70 years.
- Male and Female.
- Renal transplant performed at least 1 year before inclusion.
- Bad clinical evolution: patients with renal dysfunction and positive biopsy to rejection OR significant increase in strength of DSA expressed as Luminex MFI. Specifically, the following two criteria must comply:
- Good clinical evolution: patients without rejection episodes, negative DSA, stable renal function and no changes in treatment in the past 12 months. ALL the following criteria must apply
Key exclusion criteria (8 listed)
- Rejection of informed consent
- Active systemic infections that needed antimicrobial treatment in the past two months
- Active immune-based diseases with acute outbreaks in the past 12 months, despite immunosuppressive treatment
- Severe ischemia-reperfusion injury of current renal transplant with delayed graft function objectively evident at more than 20 days after transplant AND/OR kidney transplanted from a deceased, very elderly donor (>80 years)
- Double transplant (renal + another organ)
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 |
|---|---|---|
| NA-Observational onlyNA-Observational only | Other | ARM 1-Bad vs Good Clinical Evolution, ARM 2-Stable Renal Transplant Patients |
Primary outcome
Evaluate the robustness of Immunobiogram® (IMBG) as an in vitro Diagnostic Bioassay to study the sensitivity/resistance patterns of Immunosuppressant drugs in Renal Transplantation
Time frame: Baseline and 30 days
Robustness of Immunobiogram® (IMBG) as an In Vitro Diagnostic Bioassay to study the sensitivity/resistance patterns of Immunosuppressant drugs in Renal Transplantation, evaluated as follows: * Immunobiogram® offers personal sensitivity/resistance patterns of Immunosuppressive Medications (IM), with a range of responses for each IM drug considering all patients included * Immunobiogram® shows intrasubject consistency in terms of similarity with a maximum +/- 20% of variation in the inhibitory dose/distance 50 (ID50), in the three IMBG performed on inclusion; and additionally, similar consistency must be observed in the last three IMBG performed one month after inclusion
2 secondary outcomes
Evaluate intrasubject and inter-time consistency of Immunobiogram®
Time frame: Baseline and 30 days
Evaluate the correlation of Immunobiogram® sensitivity/resistance patterns with clinical evolution
Time frame: Baseline
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 Dec 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.
Julio Pascual, MD, PhD principal investigator
Parc du Salut Mar
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 Biohope Scientific Solutions for Human Health, S.L. at 1 site in United States.
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 17 inclusion and 8 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 Dec 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 United States. 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?
Evaluate the robustness of Immunobiogram® (IMBG) as an in vitro Diagnostic Bioassay to study the sensitivity/resistance patterns of Immunosuppressant drugs in Renal Transplantation (time frame: Baseline and 30 days). 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 Dec 2023.