Renal TransplantationPhase 3I4BiSNCT02444429
3-month Screening Biopsy to Optimize the Immunosuppression in Renal Transplantation
A Phase 3 study testing Corticosteroid boluses Methylprednisolone, No therapeutic modification and Stop maintenance corticotherapy in people with Renal Transplantation, run by Hospices Civils de Lyon at 8 sites in France.
Trial summary
Renal transplantation represents currently the best therapeutic alternative for end-stage renal failure, not only in terms of patient outcomes (better quality of life and longer survival), but also in terms of costs for the society. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Transplantation
- What is being tested?
- Corticosteroid boluses Methylprednisolone, No therapeutic modification and Stop maintenance corticotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 346 participants
- Where
- 8 sitesFrance
- Study dates
- 2 Sep 2015to 21 Jun 2024
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Common to both sub-studies (A and B)
- Renal transplant patient aged between 18 and 75.
- Patient who received a first or second renal graft
- Immunosuppressive treatment consisting of an anti-calcineurin [cyclosporine (trough levels: 150<T0<300)], or tacrolimus (trough levels: 8<T0<12), mycophenolate mofetil and corticosteroids.
- Patient who benefited from a screening renal biopsy 3 months after the graft
- Patient who gave their informed consent
Show all 13Show fewer
- Patient affiliated to a social security scheme or being a beneficiary of such a scheme
- Specific to sub-study A
- Presence of "borderline" inflammatory infiltrates on the screening biopsy at 3 months as defined by the Banff classification 2013:
- Absence of vascular lesions (v0) and:
- tubulitis regardless of its significance (t1-3) with minimum interstitial infiltrate (i0-i1) OR
- interstitial infiltrates (i2-3) without significant tubulitis (≤ t1)
- Specific to sub-study B Absence of significant inflammatory infiltrates (i0-1 and t0) on the screening biopsy at 3 months
Who cannot join
- Common to both sub-studies (A and B)
- Histological subclinical rejection criteria on the screening biopsy at 3 months (Banff 2009: > i2+t2)
- Donor specific antibodies in historical serum or de novo appearance during the first 3 months
- Humoral lesions on the 3-month biopsy (Banff score g+ptc>2)
- "Classic" acute rejection episode proven by biopsy during the first 3 months
- Multiorgan transplantation
Show all 10Show fewer
- 3rd (or subsequent) renal transplantation
- BK virus-associated nephropathy on the screening biopsy
- Contraindication to the 1-year screening biopsy
- Specific to sub-study B Initial nephropathy with a high risk of recurrence on corticosteroid withdrawal: segmental and focal and segmental glomerulosclerosis, lupus nephritis, vasculitis, or membranous glomerulonephritis
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Service de Néphrologie,Transplantation, Dialyse I - Hôpital Pellegrin - CHU Bordeaux
Bordeaux, 33000
Service de Néphrologie, Hémodialyse, Transplantations Rénales - Hôpital de la Cavale Blanche - CHU de Brest
Brest, 29609
Service de Néphrologie - Hôpital Claude Huriez - CHU de Lille
Lille, 59037
Service de Néphrologie, Transplantation et Immunologie Clinique - Hôpital Edouard Herriot - Hospices Civils de Lyon
Lyon, 69437
Institut de Transplantation, Urologie et Néphrologie (ITUN) - CHU de Nantes
Nantes, 44093
Service de Transplantation - Hôpital Universitaire Necker
Paris, 75015
Service de Néphrologie et Transplantation - Nouvel Hôpital Civil - CHRU Strasbourg
Strasbourg, 67091
Département de Néphrologie et Transplantation d'Organes - Hôpital Rangueil - CHU de Toulouse
Toulouse, 31059
About this study
Official title: Evaluation of a Strategy Based on the 3-month Screening Biopsy to Optimize the Immunosuppression in Renal Transplantation: the I4BiS Study
Renal transplantation represents currently the best therapeutic alternative for end-stage renal failure, not only in terms of patient outcomes (better quality of life and longer survival), but also in terms of costs for the society.
Progress achieved in the last 20 years has resulted in a drastic reduction of the incidence of "classic" (i.e. clinically patent) acute cellular rejection episodes.
Read more
Unfortunately, and rather unexpectedly, this progress has had hardly any effect on the frequency of the loss of kidney transplants beyond the first year, as shown by the stagnation of grafts' half lives.
Furthermore, the use of immunosuppressant combinations that are more and more powerful has an impact on adverse effects in recipients, including an increased incidence of infections, cancers, but also metabolic complications (diabetes, osteoporosis, dyslipidemia, etc.), which are cause of significant morbi-mortality.
In an attempt to improve on these disappointing outcomes, some teams have offered to perform screening biopsies: i.e. routine biopsies at specific time points during the follow up, irrespective of graft function. Their primary interest is to allow a pathological analysis of the graft at an early stage, i.e. when potential histological lesions allow for a diagnosis but before these lesions impact on graft's function. Indeed, it has been clearly demonstrated that therapeutic adjustments intended to protect the grafts are most effective when introduced early. There is a fairly broad consensus to perform these biopsies three months and one year after the transplantation. Performing screening biopsies has led to the identification of "subclinical" forms of rejection, i.e. graft infiltration by recipient immune effectors meeting the Banff histological criteria, but without increase in creatininemia.
Assuming that about 10% of screening biopsies performed at 3 months reveal a subclinical rejection, which needs to be treated, the management strategy for the remaining 90% of patients, whose biopsies show either i) a mild inflammatory infiltrates: i.e. "borderline changes", or ii) the complete absence of immune effectors in the graft is, poorly standardized.
The investigators therefore propose to conduct a prospective randomized trial to answer these questions simultaneously by evaluating a strategy to optimize the immunosuppression of renal graft recipients based on the presence or absence of subclinical intragraft inflammatory infiltrates in the screening biopsy performed at 3 months post transplantation. Patients with borderline changes (sub-study A) will be randomized to receive a treatment for rejection (corticosteroid boluses). Patients without inflammation in their graft (sub-study B) will be randomized for corticosteroid withdrawal. Impact on graft function, progression of histological lesions and incidence of morbidity will be evaluated.
- Conditions
- Renal Transplantation
- Being tested
- Corticosteroid boluses Methylprednisolone, No therapeutic modification, Stop maintenance corticotherapy
- Keywords
- Screening renal biopsy, Immunosuppression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corticosteroid boluses MethylprednisoloneDrug
Intensification of the corticotherapy in accordance with the validated protocol for the treatment of "classic" and subclinical acute rejections: 3 bolus Methylprednisolone 500 mg IV at D1, D2 and D3 then decreasing during 10-15 days at 1mg/kg/d and down to the maintenance dose.
An anti-pneumocystis and anti-CMV prophylaxis will be systemically introduced for 3 months.
The rest of maintenance immunosuppressive regimen (mycophenolate mofetil and anti-calcineurin) will remain unaltered
No therapeutic modificationOther
No therapeutic modification: continuation of the corticotherapy at the maintenance dose and maintaining unaltered the rest of immunosuppressive treatment (mycophenolate mofetil and anti-calcineurin).
Stop maintenance corticotherapyOther
Immediate withdrawal of maintenance corticotherapy. Maintaining unaltered the rest of immunosuppressive treatment (mycophenolate mofetil and anti-calcineurin).
| Study group | Role | What they receive |
|---|---|---|
| Sub-study A experimental arm | Experimental | This experimental arm corresponds to patients with "borderline" infiltrates at 3 months, who will be randomized to receive a treatment for rejection (intensification of the corticotherapy with corticosteroid boluses = Corticosteroid boluses Methylprednisolone ) Receives: Drug: Corticosteroid boluses Methylprednisolone |
| Sub-study A control arm | Active comparator | This control arm corresponds to patients with "borderline" infiltrates at 3 months, who will be randomized to not change their immunosuppressive treatment (No therapeutic modification) Receives: Other: No therapeutic modification |
| Sub-study B experimental arm | Experimental | This experimental arm corresponds to patients without significant infiltrates 3 months, who will be randomized to stop maintenance corticotherapy (Stop maintenance corticotherapy ) Receives: Other: Stop maintenance corticotherapy |
| Sub-study B control arm | Active comparator | This control arm corresponds to patients without significant infiltrates 3 months, who will be randomized to not change their immunosuppressive treatment (No therapeutic modification) Receives: Other: No therapeutic modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of graft inflammatory lesions
Interstitial infiltrate (i) and tubulitis (t) will be scored at 3 months and 1 year post transplantation using Banff classification (patients will be recruted 3 months after transplantation)
- Patient with "borderline" infiltrates at 3 months will be randomized to receive a treatment for rejection (sub-study A), with the aim of demonstrating the superiority of this strategy in terms of infiltrates involution (superiority study).
- Patient without significant infiltrates at 3 months will be randomized for maintenance corticotherapy withdrawal (sub-study B), with the aim of showing that this strategy does not cause an increase in the percentage of "borderline" infiltrates compared to the strategy that maintains the corticotherapy (non-inferiority study).
Measured: 9 months
Secondary outcomes (13)
Graft function at 1 year post-transplantation
Measurement of the glomerular filtration rate by iohexol clearance at 1 year post transplantation (unit: ml/min:1.73m2)
Measured: 9 months
Graft function at 1 year post-transplantation
Evolution of proteinuria between 3 months and 1 year (unit: g/24h).
Measured: 9 months
Evolution of chronic histological lesions
Interstitial fibrosis will be quantified at 3 months and 1 year using a computerized color image analysis technique (unit = % fibrosis = 100*(green interstitial pixels / total interstitial pixels))
Measured: 9 months
Evolution of chronic histological lesions
The 4 basic chronic lesions (unit = chronic glomerular damage [cg]; interstitial fibrosis [ci]; tubular fibrosis [ct]; vascular intimal thickening [cv]) will be scored at 3 months and 1 year using Banff classification)
Measured: 9 months
Evaluation of the immunological risk associated with the different strategies of corticosteroid treatment adaptation
Percentage of patients showing the appearance of donor specific anti-HLA antibodies using the Luminex method® between the randomization (3 months) and the end of follow-up (1 year). (unit = % of patient)
Measured: 9 months
Evaluation of the immunological risk associated with the different strategies of corticosteroid treatment adaptation
Proportion of patients showing an increase in humoral lesions (Banff score g+ptc) ≥ 2 on the screening biopsy at 1-year between the randomization (3 months) and the end of follow-up (1 year). (unit = % of patient)
Measured: 9 months
Evaluation of the immunological risk associated with the different strategies of corticosteroid treatment adaptation
Proportion of patients showing ≥ 1 acute rejection episodes (cellular or humoral) proven by biopsy between the randomization (3 months) and the end of follow-up (1 year). (unit = % of patient)
Measured: 9 months
Evaluation of the metabolic tolerance profile associated with the different strategies of corticosteroid treatment adaptation
Comparison of the data from the Holter monitor taken between 3 months and 1 year post-transplantation. (unit = mm of Hg)
Measured: 9 months
Evaluation of the metabolic tolerance profile associated with the different strategies of corticosteroid treatment adaptation
Comparison of the data from the orally induced hyperglycemia test taken between 3 months and 1 year post-transplantation. (unit = mmol/l)
Measured: 9 months
Evaluation of the metabolic tolerance profile associated with the different strategies of corticosteroid treatment adaptation
Comparison of the data from the lipid profile taken between 3 months and 1 year post-transplantation. (unit = mmol/l)
Measured: 9 months
Evaluation of the metabolic tolerance profile associated with the different strategies of corticosteroid treatment adaptation
Comparison of the data from the bone mineral density, taken between 3 months and 1 year post-transplantation. (unit = g/cm2)
Measured: 9 months
Evaluation of the infectious tolerance profile associated with the different strategies of corticosteroid treatment adaptation
Number of infectious episodes requiring treatment during the follow-up period between the randomization (3 months) and the end of follow-up (1 year). (unit = nb of episode)
Measured: 9 months
Evaluation of the impact of the different strategies for corticosteroid use on quality of life.
Evolution of the patients' quality of life using self-questionnaires, adapted and validated for the French language (SF36), between the randomization (3 months) and the end of follow-up (1 year). (unit = SF 36 score)
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study start2 Sep 2015
- Primary completion21 Jun 2024
- Study completion21 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantationStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 346 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier THAUNAT, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444429
- Sponsor's protocol ID
- 2014.848
- Other IDs
- 2014-005425-13, 2014
- Acronym
- I4BiS
- Status last verified
- Sep 2025
- First submitted
- 25 Mar 2015
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Strategy Based on the 3-month Screening Biopsy to Optimize the Immunosuppression in Renal Transplantation: the I4BiS Study
- ClinicalTrials.gov ID
- NCT02444429
- Acronym / sponsor ID
- I4BiS / 2014.848
- Conditions
- Renal Transplantation
- Keywords
- Screening renal biopsy, Immunosuppression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 346 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 2 Sep 2015 (actual)
- Primary completion
- 21 Jun 2024 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 14 May 2015 (estimated)
- 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.
Renal transplantation represents currently the best therapeutic alternative for end-stage renal failure, not only in terms of patient outcomes (better quality of life and longer survival), but also in terms of costs for the society.
Progress achieved in the last 20 years has resulted in a drastic reduction of the incidence of "classic" (i.e. clinically patent) acute cellular rejection episodes.
Unfortunately, and rather unexpectedly, this progress has had hardly any effect on the frequency of the loss of kidney transplants beyond the first year, as shown by the stagnation of grafts' half lives.
Furthermore, the use of immunosuppressant combinations that are more and more powerful has an impact on adverse effects in recipients, including an increased incidence of infections, cancers, but also metabolic complications (diabetes, osteoporosis, dyslipidemia, etc.), which are cause of significant morbi-mortality.
In an attempt to improve on these disappointing outcomes, some teams have offered to perform screening biopsies: i.e. routine biopsies at specific time points during the follow up, irrespective of graft function. Their primary interest is to allow a pathological analysis of the graft at an early stage, i.e. when potential histological lesions allow for a diagnosis but before these lesions impact on graft's function. Indeed, it has been clearly demonstrated that therapeutic adjustments intended to protect the grafts are most effective when introduced early. There is a fairly broad consensus to perform these biopsies three months and one year after the transplantation. Performing screening biopsies has led to the identification of "subclinical" forms of rejection, i.e. graft infiltration by recipient immune effectors meeting the Banff histological criteria, but without increase in creatininemia.
Assuming that about 10% of screening biopsies performed at 3 months reveal a subclinical rejection, which needs to be treated, the management strategy for the remaining 90% of patients, whose biopsies show either i) a mild inflammatory infiltrates: i.e. "borderline changes", or ii) the complete absence of immune effectors in the graft is, poorly standardized.
The investigators therefore propose to conduct a prospective randomized trial to answer these questions simultaneously by evaluating a strategy to optimize the immunosuppression of renal graft recipients based on the presence or absence of subclinical intragraft inflammatory infiltrates in the screening biopsy performed at 3 months post transplantation. Patients with borderline changes (sub-study A) will be randomized to receive a treatment for rejection (corticosteroid boluses). Patients without inflammation in their graft (sub-study B) will be randomized for corticosteroid withdrawal. Impact on graft function, progression of histological lesions and incidence of morbidity will be evaluated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sub-study A experimental arm | Experimental | Drug: Corticosteroid boluses MethylprednisoloneThis experimental arm corresponds to patients with "borderline" infiltrates at 3 months, who will be randomized to receive a treatment for rejection (intensification of the corticotherapy with corticosteroid boluses = Corticosteroid boluses Methylprednisolone ) |
| Sub-study A control arm | Active comparator | Other: No therapeutic modificationThis control arm corresponds to patients with "borderline" infiltrates at 3 months, who will be randomized to not change their immunosuppressive treatment (No therapeutic modification) |
| Sub-study B experimental arm | Experimental | Other: Stop maintenance corticotherapyThis experimental arm corresponds to patients without significant infiltrates 3 months, who will be randomized to stop maintenance corticotherapy (Stop maintenance corticotherapy ) |
| Sub-study B control arm | Active comparator | Other: No therapeutic modificationThis control arm corresponds to patients without significant infiltrates 3 months, who will be randomized to not change their immunosuppressive treatment (No therapeutic modification) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Common to both sub-studies (A and B)
- Specific to sub-study A
- Specific to sub-study B Absence of significant inflammatory infiltrates (i0-1 and t0) on the screening biopsy at 3 months
Key exclusion criteria (10 listed)
- Common to both sub-studies (A and B)
- Specific to sub-study B Initial nephropathy with a high risk of recurrence on corticosteroid withdrawal: segmental and focal and segmental glomerulosclerosis, lupus nephritis, vasculitis, or membranous glomerulonephritis
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 |
|---|---|---|
| Corticosteroid boluses MethylprednisoloneIntensification of the corticotherapy in accordance with the validated protocol for the treatment of "classic" and subclinical acute rejections: 3 bolus Methylprednisolone 500 mg IV at D1, D2 and D3 then decreasing during 10-15 days at 1mg/kg/d and down to the maintenance dose. An anti-pneumocystis and anti-CMV prophylaxis will be systemically introduced for 3 months. The rest of maintenance immunosuppressive regimen (mycophenolate mofetil and anti-calcineurin) will remain unaltered | Drug | Sub-study A experimental arm |
| No therapeutic modificationNo therapeutic modification: continuation of the corticotherapy at the maintenance dose and maintaining unaltered the rest of immunosuppressive treatment (mycophenolate mofetil and anti-calcineurin). | Other | Sub-study A control arm, Sub-study B control arm |
| Stop maintenance corticotherapyImmediate withdrawal of maintenance corticotherapy. Maintaining unaltered the rest of immunosuppressive treatment (mycophenolate mofetil and anti-calcineurin). | Other | Sub-study B experimental arm |
Primary outcome
Evolution of graft inflammatory lesions
Time frame: 9 months
Interstitial infiltrate (i) and tubulitis (t) will be scored at 3 months and 1 year post transplantation using Banff classification (patients will be recruted 3 months after transplantation) A) Patient with "borderline" infiltrates at 3 months will be randomized to receive a treatment for rejection (sub-study A), with the aim of demonstrating the superiority of this strategy in terms of infiltrates involution (superiority study). B) Patient without significant infiltrates at 3 months will be randomized for maintenance corticotherapy withdrawal (sub-study B), with the aim of showing that this strategy does not cause an increase in the percentage of "borderline" infiltrates compared to the strategy that maintains the corticotherapy (non-inferiority study).
13 secondary outcomes
Graft function at 1 year post-transplantation
Time frame: 9 months
Graft function at 1 year post-transplantation
Time frame: 9 months
Evolution of chronic histological lesions
Time frame: 9 months
Evolution of chronic histological lesions
Time frame: 9 months
Evaluation of the immunological risk associated with the different strategies of corticosteroid treatment adaptation
Time frame: 9 months
Evaluation of the immunological risk associated with the different strategies of corticosteroid treatment adaptation
Time frame: 9 months
Evaluation of the immunological risk associated with the different strategies of corticosteroid treatment adaptation
Time frame: 9 months
Evaluation of the metabolic tolerance profile associated with the different strategies of corticosteroid treatment adaptation
Time frame: 9 months
Evaluation of the metabolic tolerance profile associated with the different strategies of corticosteroid treatment adaptation
Time frame: 9 months
Evaluation of the metabolic tolerance profile associated with the different strategies of corticosteroid treatment adaptation
Time frame: 9 months
Evaluation of the metabolic tolerance profile associated with the different strategies of corticosteroid treatment adaptation
Time frame: 9 months
Evaluation of the infectious tolerance profile associated with the different strategies of corticosteroid treatment adaptation
Time frame: 9 months
Evaluation of the impact of the different strategies for corticosteroid use on quality of life.
Time frame: 9 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 1 Oct 2025.
Related trials for Renal Transplantation
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
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
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.
Olivier THAUNAT, MD principal investigator
Hospices Civils de Lyon
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Corticosteroid boluses Methylprednisolone, No therapeutic modification and Stop maintenance corticotherapy in people with Renal Transplantation, run by Hospices Civils de Lyon at 8 sites in France.
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 13 inclusion and 10 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 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Evolution of graft inflammatory lesions (time frame: 9 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 1 Oct 2025; AzTrials last refreshed its copy on 6 Nov 2026.