Kidney transplant rejection trial pulled before it began
NCT ID NCT02113891
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study was designed to test whether the drug eculizumab could treat early, symptom-free antibody-mediated rejection in kidney transplant recipients. The goal was to prevent long-term damage and chronic rejection. However, the trial was withdrawn before enrolling any participants, so no data were collected.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Eculizumab (Soliris)
- What this could lead to
- If this approach had worked, it could have pointed toward a way to prevent chronic rejection and extend kidney transplant survival.
- What could go wrong
- The trial was withdrawn before enrolling any participants, so no results are available. The approach remains unproven and carries risks like increased infections due to complement blockade.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Start date
-
Feb 2015
- Expected to finish
-
Nov 2017
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 * 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. Exclusion Criteria: * 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 * 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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.