Subclinical Acute Antibody-mediated Rejection in Kidney TransplantationPhase 1/2TAMARCINNCT02113891
Eculizumab Therapy for Subclinical Antibody-mediated Rejection in Kidney Transplantation
A Phase 1/2 study testing Eculizumab in people with Subclinical Acute Antibody-mediated Rejection in Kidney Transplantation, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Advances in renal transplantation have increased life-expectancy in patients with end-stage kidney disease. Conventional immunosuppressive drugs prevent efficiently early allograft losses due to T-cell mediated rejection. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Subclinical Acute Antibody-mediated Rejection in Kidney Transplantation
- What is being tested?
- Eculizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Nov 2017
- Phase
- Phase 1/2
- 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
- Male or female patients aged 18 -75 years.
- Patients having received a kidney transplant from a living or deceased donor
- Patients with stable renal function
- Sensitized patient with at least one anti-HLA class II DSA (MFI > 1000) within the first 3 months.
- Adequate 3-month-protocol biopsy exhibiting microcirculation inflammation defined by glomerulitis Banff score (g) superior or egal 2 and /or peri-tubular capillaritis Banff score (ptc) superior or egal 2, AND the sum of scores g + ptc superior or egal 3.
- C4d positive staining on 3-month-protocol biopsy
Show all 9Show fewer
- Adequate 3-month-protocol biopsy exhibiting limited scarred areas as defined as IF/TA score (ci + ct) inferior or egal 2 and no or minimal transplant glomerulopathy (cg inferior or egal 1)
- Patients who have given written informed consent to participate in all aspects of the study.
- Females of childbearing potential must have a negative pregnancy test within 48 hours prior to the first eculizumab administration.
Who cannot join
- Patients with known hypersensitivity to eculizumab or drugs with similar chemical structure.
- Patients having experienced and having been treated for an acute antibody-mediated rejection within the first 3 months post-transplant
- Patients with multi-organ transplant
- Female patients who are pregnant, lactating or of child bearing potential and not practicing an approved method of birth control.
- Patients with a known malignancy or history of malignancy other than excised basal or squamous cell carcinoma of the skin
- HBV, HCV or HIV-chronically infected patients
Show all 14Show fewer
- Patients with evidence of severe liver disease, including abnormal liver profile (aspartate aminotransferase [AST], alanine aminotransferases [ALT] or total bilirubin > 3 times upper limit of normal at screening.
- Patients with current severe infection.
- Ongoing meningococcal infection
- Patient with systemic lupus erythematosus disease and / or anti-phospholipid antibodies
- Patients with any surgical or medical condition, which in the opinion of the investigator precludes enrollment in this trial
- Patients who live far from the transplant center and are unable to comply with all study visits.
- Long-term anticoagulation therapy or other contraindication to graft biopsies
- Positive BKV viremia during the first three months post-transplant
About this study
Official title: Treatment of Subclinical Antibody-mediated Acute Rejection in Kidney Transplant Recipients With the Complement Inhibitor Eculizumab.
Advances in renal transplantation have increased life-expectancy in patients with end-stage kidney disease. Conventional immunosuppressive drugs prevent efficiently early allograft losses due to T-cell mediated rejection. However, emerging data suggest that the majority of late kidney failures may be attributable to antibody-mediated rejection (AMR), which poorly responds to the currently available therapeutics. Complement-fixing donor-specific anti-HLA antibodies are associated with the worst outcome in keeping with the well-established role of the complement in AMR pathogenesis. Eculizumab, the first licenced complement blocker, has been found efficient in reducing the occurrence of AMR lesions in highly sensitized patients. A few reports also suggest that complement blockade may be of great value as salvage therapy for graft-threatening severe AMR. However, no information is available in the literature about the interest of complement blockade in curbing the progression of subclinical acute AMR to chronic AMR.
The purpose of this study is to determine whether complement blockade with eculizumab is effective and safe in the treatment of subclinical AMR in sensitized kidney transplant recipients.
Read more
Despite appropriate therapies, up to 75% of patients having received a renal transplant with preformed donor-specific antibody display subclinical AMR on their 3-month protocol biopsy. Subclinical AMR is defined by histological lesions of AMR concomitant with stable graft function. Moreover, the extent of these lesions at 3 month post-transplant correlates with the occurrence of irreversible scars and chonic antibody-mediated rejection on the 12-month biopsy.
This study aims to explore the efficacy and safety of eculizumab in patients exhibiting subclinical AMR on their 3 month-post-transplant biopsy, to reduce or even normalize microcirculation inflammation, and to prevent chronic rejection (transplant glomerulopathy) on the 12 month-screening biopsy. Eculizumab-treated patients will be compared with historical controls, matched for the lesions on the 3 month biopsy.
Read the detailed description
Advance in renal transplantation for the treatment of patients with end-stage kidney failure have led to significant improvements in patient survival. T-cell directed immunotherapeutic agents are capable of preventing early allograft loss and represent the cornerstone of current maintenance immunosuppressive regimens. However, recent studies have pointed out that the majority (63%) of late kidney failures could be attributable to antibody-mediated rejection. Microcirculation inflammation (poly and mononuclear cells within glomerular and peritubular capillaries) correlates best with alloantibody-induced endothelial damages and complement-fixing anti-HLA antibodies, predicts evolution toward chronic antibody mediated rejection (transplant glomerulopathy), and is associated with a poor outcome. Microcirculation inflammation, the hallmark lesions of AMR, are frequently observed (75%) on screening biopsies performed in sensitized patients having received a renal transplant across a positive crossmatch due to preformed DSA, despite intensive prophylactic therapy (including polyclonal immunoglobulin, plasma exchanges and rituximab).
Altogether these findings underscore the need for innovative treatment to better control the humoral arm of chronic rejection in patients with donor-specific anti-HLA antibodies. Short-term eculizumab treatment might be a promising avenue. Complement blockade with eculizumab has been found efficient in reducing the occurrence of AMR lesions in highly sensitized patients. A few reports also suggest that complement blockade may be of great value as salvage therapy for graft-threatening severe AMR. However, no information is available in the literature about the efficacy of complement blockade in curbing the progression of subclinical AMR to chronic AMR.
The primary objectives of this study are:
- To determine the effectiveness of eculizumab in reducing durably alloantibody-induced microcirculation inflammation and preventing chronic microcirculation damages on 12-month screening biopsies.
The secondary objectives of this study are:
- To assess the effect of eculizumab on serum creatinine levels, amount of proteinuria, and measured and estimated Glomerular Filtration Rate (mGFR) between 3 and 12 months post-transplant.
- To determine the effectiveness of eculizumab in hampering the appearance of interstitial fibrosis and tubular atrophy (IF/TA), and dampening down alloantibody-induced accelerated arteriosclerosis on 1-year-post-transplant biopsy.
- Incidence of biopsy-proven antibody-mediated acute rejection (rise of creatinine value higher than 20% above the baseline value).
- To monitor DSA levels at 3, 6 and 12 months post-transplant with solid-phase assay (Luminex).
- To assess vital signs (such as systolic, diastolic blood pressure, heart rate, weight, temperature) and laboratory parameters at every eculizumab administration.
- To collect safety data on infections, cardiovascular events, and malignancies
- To monitor endothelial, platelet and leukocyte microparticles as well as endothelial cell progenitors
- To quantify the number of endothelial and NK expressed genes that correlate with AMR
This is an open-label exploratory study which evaluates eculizumab administration in sensitized patients with subclinical antibody-mediated rejection at 3 month-post-transplant. Ten patients fulfilling inclusion/exclusion criteria will be enrolled into the study and compared with 20 historical controls matched for the sensitization and histological lesions at 3 months. The patients enrolled in this study will be given eculizumab from 3 to 12 month post-transplant, according to the standard protocol in adults heavier than 40 kg (900 mg weekly for 4 weeks, 1200 mg for the fifth infusion and 1200 mg every other week thereafter).
Clinical and laboratory evaluations including vital signs and safety laboratory values will be monitored at predetermined time points.
- Being tested
- Eculizumab
- Keywords
- Antibody-mediated rejection, Complement blockade, Eculizumab, Kidney transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EculizumabDrug
Also called Soliris
Eculizumab induction: 900 mg IV every 7 days for 4 doses, a fifth 1200 mg dose 7 days later Eculizumab maintenance: 15 1200 mg doses every 14 days.
(each patient will receive a total of 20 eculizumab doses during the whole treatment period from 3 month to 12 month post-transplant).
| Study group | Role | What they receive |
|---|---|---|
| Eculizumab | Experimental | Eculizumab will be given in addition to standard immunosuppression regimen (tacrolimus, mycophenalte mofeti, prednisone) Receives: Drug: Eculizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microcirculation inflammation
Compare trajectories of g (0-3) and ptc (0-3) Banff scores
Measured: 12-month screening biopsies
Transplant glomerulopathy
Compare trajectories of cg (0-3) Banff score
Measured: 12 month screening biopsies
Microcirculation inflammation
Compare trajectories of g (0-3) and ptc (0-3) Banff scores
Measured: 3 month screening biopsies
Transplant glomerulopathy
Compare trajectories of cg (0-3) Banff score
Measured: 3 month screening biopsies
Secondary outcomes (11)
Measured Glomerular Filtration Rate (Iohexol clearance)
Compare trajectories of GFR change and percent GFR change between the study group and historiacl controls
Measured: 12 months post-transplant
Incidence of adverse effects
Monitoring of adverse events as well as evaluation of changes in laboratory parameters
Measured: at 15 months post-transplant
Incidence of biopsy-proven acute rejection
graft biopsy for cause (rise in creatinine level…)
Measured: at 12 months post-transplant
CH50
Monitoring of eculizumab pharmacodynamic with an in vitro complement activity assay (CH50).
Measured: at 15 months post-transplant (baseline, each infusion, study completion)
Endothelial Microparticles and Progenitors
Number of endothelial and leukocyte-derived microparticules, as well as circulating endothelial progenitors as a biomarker of the graft endothelium insult.
Measured: Baseline, 1, 3, 6 and 9 months
Molecular diagnosis of AMR
Compare trajectories of endothelial and NK expressed genes between the study group and historiacl controls
Measured: 3 and 12-month post-transplant biopsy
Donor Specific Antibody titers (Luminex SA)
Monitor the persistence of DSA in the study group in comparison with historical controls.
Measured: 3 months post-transplant
Measured Glomerular Filtration Rate (Iohexol clearance)
Compare trajectories of GFR change and percent GFR change between the study group and historiacl controls
Measured: 3 months post-transplant
Donor Specific Antibody titers (Luminex SA)
Monitor the persistence of DSA in the study group in comparison with historical controls.
Measured: 12 months post-transplant
Donor Specific Antibody titers (Luminex SA)
Monitor the persistence of DSA in the study group in comparison with historical controls.
Measured: 9 months post-transplant
Donor Specific Antibody titers (Luminex SA)
Monitor the persistence of DSA in the study group in comparison with historical controls.
Measured: 6 months post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startFeb 2015
- Primary completionJul 2017 (estimated)
- Study completionNov 2017 (estimated)
Why it stopped: disengagement of the sponsor Alexion Pharmaceuticals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Subclinical Acute Antibody-mediated Rejection in Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Alexion Pharmaceuticals, Inc., URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Christophe LEGENDRE, MD, Study director, Service de Transplantation Rénale, Hôpital Necker Université Paris Descartes 149 rue de Sèvres 75015 Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113891
- Sponsor's protocol ID
- P101004
- Acronym
- TAMARCIN
- Status last verified
- Oct 2025
- First submitted
- 21 Nov 2013
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Loupy A, Suberbielle-Boissel C, Hill GS, Lefaucheur C, Anglicheau D, Zuber J, Martinez F, Thervet E, Mejean A, Charron D, Duong van Huyen JP, Bruneval P, Legendre C, Nochy D. Outcome of subclinical antibody-mediated rejection in kidney transplant recipients with preformed donor-specific antibodies. Am J Transplant. 2009 Nov;9(11):2561-70. doi: 10.1111/j.1600-6143.2009.02813.x. Epub 2009 Sep 22.
PubMed 19775320Stegall MD, Diwan T, Raghavaiah S, Cornell LD, Burns J, Dean PG, Cosio FG, Gandhi MJ, Kremers W, Gloor JM. Terminal complement inhibition decreases antibody-mediated rejection in sensitized renal transplant recipients. Am J Transplant. 2011 Nov;11(11):2405-13. doi: 10.1111/j.1600-6143.2011.03757.x. Epub 2011 Sep 22.
PubMed 21942930Loupy A, Lefaucheur C, Vernerey D, Prugger C, Duong van Huyen JP, Mooney N, Suberbielle C, Fremeaux-Bacchi V, Mejean A, Desgrandchamps F, Anglicheau D, Nochy D, Charron D, Empana JP, Delahousse M, Legendre C, Glotz D, Hill GS, Zeevi A, Jouven X. Complement-binding anti-HLA antibodies and kidney-allograft survival. N Engl J Med. 2013 Sep 26;369(13):1215-26. doi: 10.1056/NEJMoa1302506.
PubMed 24066742Zuber J, Le Quintrec M, Krid S, Bertoye C, Gueutin V, Lahoche A, Heyne N, Ardissino G, Chatelet V, Noel LH, Hourmant M, Niaudet P, Fremeaux-Bacchi V, Rondeau E, Legendre C, Loirat C; French Study Group for Atypical HUS. Eculizumab for atypical hemolytic uremic syndrome recurrence in renal transplantation. Am J Transplant. 2012 Dec;12(12):3337-54. doi: 10.1111/j.1600-6143.2012.04252.x. Epub 2012 Sep 7.
PubMed 22958221
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Subclinical Antibody-mediated Acute Rejection in Kidney Transplant Recipients With the Complement Inhibitor Eculizumab.
- ClinicalTrials.gov ID
- NCT02113891
- Acronym / sponsor ID
- TAMARCIN / P101004
- Keywords
- Antibody-mediated rejection, Complement blockade, Eculizumab, Kidney transplantation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: disengagement of the sponsor Alexion Pharmaceuticals
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Alexion Pharmaceuticals, Inc., URC-CIC Paris Descartes Necker Cochin
- Study start
- Feb 2015
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 15 Apr 2014 (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.
Advances in renal transplantation have increased life-expectancy in patients with end-stage kidney disease. Conventional immunosuppressive drugs prevent efficiently early allograft losses due to T-cell mediated rejection. However, emerging data suggest that the majority of late kidney failures may be attributable to antibody-mediated rejection (AMR), which poorly responds to the currently available therapeutics. Complement-fixing donor-specific anti-HLA antibodies are associated with the worst outcome in keeping with the well-established role of the complement in AMR pathogenesis. Eculizumab, the first licenced complement blocker, has been found efficient in reducing the occurrence of AMR lesions in highly sensitized patients. A few reports also suggest that complement blockade may be of great value as salvage therapy for graft-threatening severe AMR. However, no information is available in the literature about the interest of complement blockade in curbing the progression of subclinical acute AMR to chronic AMR.
The purpose of this study is to determine whether complement blockade with eculizumab is effective and safe in the treatment of subclinical AMR in sensitized kidney transplant recipients.
Despite appropriate therapies, up to 75% of patients having received a renal transplant with preformed donor-specific antibody display subclinical AMR on their 3-month protocol biopsy. Subclinical AMR is defined by histological lesions of AMR concomitant with stable graft function. Moreover, the extent of these lesions at 3 month post-transplant correlates with the occurrence of irreversible scars and chonic antibody-mediated rejection on the 12-month biopsy.
This study aims to explore the efficacy and safety of eculizumab in patients exhibiting subclinical AMR on their 3 month-post-transplant biopsy, to reduce or even normalize microcirculation inflammation, and to prevent chronic rejection (transplant glomerulopathy) on the 12 month-screening biopsy. Eculizumab-treated patients will be compared with historical controls, matched for the lesions on the 3 month biopsy.
Detailed description
Advance in renal transplantation for the treatment of patients with end-stage kidney failure have led to significant improvements in patient survival. T-cell directed immunotherapeutic agents are capable of preventing early allograft loss and represent the cornerstone of current maintenance immunosuppressive regimens. However, recent studies have pointed out that the majority (63%) of late kidney failures could be attributable to antibody-mediated rejection. Microcirculation inflammation (poly and mononuclear cells within glomerular and peritubular capillaries) correlates best with alloantibody-induced endothelial damages and complement-fixing anti-HLA antibodies, predicts evolution toward chronic antibody mediated rejection (transplant glomerulopathy), and is associated with a poor outcome. Microcirculation inflammation, the hallmark lesions of AMR, are frequently observed (75%) on screening biopsies performed in sensitized patients having received a renal transplant across a positive crossmatch due to preformed DSA, despite intensive prophylactic therapy (including polyclonal immunoglobulin, plasma exchanges and rituximab).
Altogether these findings underscore the need for innovative treatment to better control the humoral arm of chronic rejection in patients with donor-specific anti-HLA antibodies. Short-term eculizumab treatment might be a promising avenue. Complement blockade with eculizumab has been found efficient in reducing the occurrence of AMR lesions in highly sensitized patients. A few reports also suggest that complement blockade may be of great value as salvage therapy for graft-threatening severe AMR. However, no information is available in the literature about the efficacy of complement blockade in curbing the progression of subclinical AMR to chronic AMR.
The primary objectives of this study are:
- To determine the effectiveness of eculizumab in reducing durably alloantibody-induced microcirculation inflammation and preventing chronic microcirculation damages on 12-month screening biopsies.
The secondary objectives of this study are:
- To assess the effect of eculizumab on serum creatinine levels, amount of proteinuria, and measured and estimated Glomerular Filtration Rate (mGFR) between 3 and 12 months post-transplant.
- To determine the effectiveness of eculizumab in hampering the appearance of interstitial fibrosis and tubular atrophy (IF/TA), and dampening down alloantibody-induced accelerated arteriosclerosis on 1-year-post-transplant biopsy.
- Incidence of biopsy-proven antibody-mediated acute rejection (rise of creatinine value higher than 20% above the baseline value).
- To monitor DSA levels at 3, 6 and 12 months post-transplant with solid-phase assay (Luminex).
- To assess vital signs (such as systolic, diastolic blood pressure, heart rate, weight, temperature) and laboratory parameters at every eculizumab administration.
- To collect safety data on infections, cardiovascular events, and malignancies
- To monitor endothelial, platelet and leukocyte microparticles as well as endothelial cell progenitors
- To quantify the number of endothelial and NK expressed genes that correlate with AMR
This is an open-label exploratory study which evaluates eculizumab administration in sensitized patients with subclinical antibody-mediated rejection at 3 month-post-transplant. Ten patients fulfilling inclusion/exclusion criteria will be enrolled into the study and compared with 20 historical controls matched for the sensitization and histological lesions at 3 months. The patients enrolled in this study will be given eculizumab from 3 to 12 month post-transplant, according to the standard protocol in adults heavier than 40 kg (900 mg weekly for 4 weeks, 1200 mg for the fifth infusion and 1200 mg every other week thereafter).
Clinical and laboratory evaluations including vital signs and safety laboratory values will be monitored at predetermined time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eculizumab | Experimental | Drug: EculizumabEculizumab will be given in addition to standard immunosuppression regimen (tacrolimus, mycophenalte mofeti, prednisone) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female patients aged 18 -75 years.
- Patients having received a kidney transplant from a living or deceased donor
- Patients with stable renal function
- Sensitized patient with at least one anti-HLA class II DSA (MFI > 1000) within the first 3 months.
- Adequate 3-month-protocol biopsy exhibiting microcirculation inflammation defined by glomerulitis Banff score (g) superior or egal 2 and /or peri-tubular capillaritis Banff score (ptc) superior or egal 2, AND the sum of scores g + ptc superior or egal 3.
Key exclusion criteria (14 listed)
- Patients with known hypersensitivity to eculizumab or drugs with similar chemical structure.
- Patients having experienced and having been treated for an acute antibody-mediated rejection within the first 3 months post-transplant
- Patients with multi-organ transplant
- Female patients who are pregnant, lactating or of child bearing potential and not practicing an approved method of birth control.
- Patients with a known malignancy or history of malignancy other than excised basal or squamous cell carcinoma of the skin
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 |
|---|---|---|
| EculizumabAlso: SolirisEculizumab induction: 900 mg IV every 7 days for 4 doses, a fifth 1200 mg dose 7 days later Eculizumab maintenance: 15 1200 mg doses every 14 days. (each patient will receive a total of 20 eculizumab doses during the whole treatment period from 3 month to 12 month post-transplant). | Drug | Eculizumab |
Primary outcome
Microcirculation inflammation
Time frame: 12-month screening biopsies
Compare trajectories of g (0-3) and ptc (0-3) Banff scores
Transplant glomerulopathy
Time frame: 12 month screening biopsies
Compare trajectories of cg (0-3) Banff score
Microcirculation inflammation
Time frame: 3 month screening biopsies
Compare trajectories of g (0-3) and ptc (0-3) Banff scores
Transplant glomerulopathy
Time frame: 3 month screening biopsies
Compare trajectories of cg (0-3) Banff score
11 secondary outcomes
Measured Glomerular Filtration Rate (Iohexol clearance)
Time frame: 12 months post-transplant
Incidence of adverse effects
Time frame: at 15 months post-transplant
Incidence of biopsy-proven acute rejection
Time frame: at 12 months post-transplant
CH50
Time frame: at 15 months post-transplant (baseline, each infusion, study completion)
Endothelial Microparticles and Progenitors
Time frame: Baseline, 1, 3, 6 and 9 months
Molecular diagnosis of AMR
Time frame: 3 and 12-month post-transplant biopsy
Donor Specific Antibody titers (Luminex SA)
Time frame: 3 months post-transplant
Measured Glomerular Filtration Rate (Iohexol clearance)
Time frame: 3 months post-transplant
Donor Specific Antibody titers (Luminex SA)
Time frame: 12 months post-transplant
Donor Specific Antibody titers (Luminex SA)
Time frame: 9 months post-transplant
Donor Specific Antibody titers (Luminex SA)
Time frame: 6 months post-transplant
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Background: PubMed 19775320Loupy A, Suberbielle-Boissel C, Hill GS, Lefaucheur C, Anglicheau D, Zuber J, Martinez F, Thervet E, Mejean A, Charron D, Duong van Huyen JP, Bruneval P, Legendre C, Nochy D. Outcome of subclinical antibody-mediated rejection in kidney transplant recipients with preformed donor-specific antibodies. Am J Transplant. 2009 Nov;9(11):2561-70. doi: 10.1111/j.1600-6143.2009.02813.x. Epub 2009 Sep 22.
- Background: PubMed 21942930Stegall MD, Diwan T, Raghavaiah S, Cornell LD, Burns J, Dean PG, Cosio FG, Gandhi MJ, Kremers W, Gloor JM. Terminal complement inhibition decreases antibody-mediated rejection in sensitized renal transplant recipients. Am J Transplant. 2011 Nov;11(11):2405-13. doi: 10.1111/j.1600-6143.2011.03757.x. Epub 2011 Sep 22.
- Background: PubMed 24066742Loupy A, Lefaucheur C, Vernerey D, Prugger C, Duong van Huyen JP, Mooney N, Suberbielle C, Fremeaux-Bacchi V, Mejean A, Desgrandchamps F, Anglicheau D, Nochy D, Charron D, Empana JP, Delahousse M, Legendre C, Glotz D, Hill GS, Zeevi A, Jouven X. Complement-binding anti-HLA antibodies and kidney-allograft survival. N Engl J Med. 2013 Sep 26;369(13):1215-26. doi: 10.1056/NEJMoa1302506.
- Background: PubMed 22958221Zuber J, Le Quintrec M, Krid S, Bertoye C, Gueutin V, Lahoche A, Heyne N, Ardissino G, Chatelet V, Noel LH, Hourmant M, Niaudet P, Fremeaux-Bacchi V, Rondeau E, Legendre C, Loirat C; French Study Group for Atypical HUS. Eculizumab for atypical hemolytic uremic syndrome recurrence in renal transplantation. Am J Transplant. 2012 Dec;12(12):3337-54. doi: 10.1111/j.1600-6143.2012.04252.x. Epub 2012 Sep 7.
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.
Christophe LEGENDRE, MD study director
Service de Transplantation Rénale, Hôpital Necker Université Paris Descartes 149 rue de Sèvres 75015 Paris, France
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Eculizumab in people with Subclinical Acute Antibody-mediated Rejection in Kidney Transplantation, run by Assistance Publique - Hôpitaux de Paris.
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 9 inclusion and 14 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: withdrawn, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Microcirculation inflammation (time frame: 12-month screening biopsies). The study lists 4 primary outcomes in all. 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 NCT02113891, which also lists 4 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 20 Nov 2025.