A Phase 2/3 interventional study of Conversion to Belatacep and Standard of care treatment (SOC regimen) with Tacrolimus in Kidney Transplant Rejection, sponsored by University Hospital, Rouen. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-09.
Sponsored by University Hospital, Rouen · Phase 2/3, Interventional, and Treatment
Antibody mediated rejection (ABMR) is a major cause of graft loss after kidney transplantation (KT) and is mainly associated with preformed anti-HLA donor specific antibodies (DSAs) (phenotype 1) or de novo DSAs (dnDSAs) (phenotype 2). Preexisting DSA-associated ABMR have superior graft survival compared with dnDSA-associated ABMR, which could partly be explained by the fact that patients with de novo DSA-associated ABMR have biopsy later, when graft dysfunction and/or proteinuria are already present. ABMR is a progressive process with an early stage called subclinical ABMR (sABMR), in which histological lesions are present in the kidney graft without clinical graft dysfunction. These early lesions are now well recognized as risk factors for transplant glomerulopathy and poor graft survival in phenotype 1 ABMR (ref 5). The impact of sABMR associated with dnDSA at any time post-transplant has been less studied and reported. Recently, a retrospective multicenter study was published, within the Spiesser Group that included 123 patients without graft dysfunction who underwent graft biopsy because of the presence of dnDSA (One Lambda, MFI > 1000). Performing a kidney graft biopsy after dnDSA indentification without renal dysfunction leads to the diagnosis of active sABMR in 35 % of cases. Nevertheless, no effect of standard of care treatment in active sABMR was observed. Very recently, an expert consensus for the recommended treatment for ABMR after KT was published. It was conclude that the clear lack of evidence but a standard of care for ABMR was nevertheless defined. Therefore, the current proposal is to evaluate a new strategy for active sABMR, testing a conversion from calcineurin inhibitor (CNI) to belatacept associated with the recently recommended standard of care (SOC) compared to continuing CNI. Belatacept might help to manage nonadherence, decrease the toxicity of CNI on an endothelium already affected by microvascular inflammation, and reduce DSA titers.
The monitoring of dnDSA after KT and an indication graft biopsy in case of appearance, even in the absence of graft dysfunction, is not part of a routine clinical practice in all KT centers. This strategy could be a valuable option, in order to begin treatment of ABMR before graft dysfunction occurs, and therefore to improve prognosis associated with phenotype 2 ABMR. Parajuli et al.4 suggested that early diagnosis and treatment of sABMR with SOC, using DSA monitoring may improve outcomes after KT, but this is a retrospective and no-randomized study. This study will be the first prospective randomized study in the context of de novo DSA. The objective is to evaluate a new combination of treatment for ABMR in the context of dnDSA with subclinical lesions and in the same time may help to determine the real incidence of sABMR in KT recipients with subclinical dnDSA. The use of belatacept in the context of sABMR to improve the non-adherence and to decrease the endothelial toxicity had never been evaluated in a prospective way.
University Hospital, Rouen is the lead sponsor of 410 studies on the registry; 104 are open to participants now.
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Screening inclusion criteria:
Randomization inclusion criteria:
Exclusion Criteria:
Screening exclusion criteria:
Randomization exclusion criteria:
\- Experimental arm: conversion to Belatacept CNI will be tapered within 3 months: 75 % of initial dose on the first month, 50 % on the second month, 25 % on the third month, and stopped and a conversion to Belatacept will be performed. It will be administered (6mg/kg) every 2W for the first 2 months and then every month until kidney graft survival.
Drug: Conversion to Belatacep
\- Control arm: Standard of care treatment (SOC regimen) with Tacrolimus Tacrolimus will be continued until kidney graft survival with objective of whole blood through levels between 6 and 8 ng/mL
Drug: Standard of care treatment (SOC regimen) with Tacrolimus
CNI will be tapered within 3 months: 75 % of initial dose on the first month, 50 % on the second month, 25 % on the third month, and stopped and a conversion to Belatacept will be performed. It will be administered (6mg/kg) every 2W for the first 2 months and then every month until kidney graft survival.
Tacrolimus will be continued until kidney graft survival with objective of whole blood through levels between 6 and 8 ng/mL
The efficacy of belatacept combined with standard of care, compared to calcineurin inhibitors (CNI) combined with standard of care, among kidney transplant recipients with sABMR
Proportion in each arm, at 12 months post randomization, of patients with: * decrease eGFR \> 20% at 12 months post randomization, according to CKD-EPI formula * or bad features on 12-month protocol biopsy: cg \> 1 * or chronic active ABMR according Banff 2019 classification, * or \< 50 % MFI reduction of DSA, * or proteinuria/creatinuria ratio \> 0.5 g/g, * or death, * or graft loss.
Time frame: over 12 months post-biopsy
Presence of chronic active ABMR
Presence of ABMR defined according to the Banff 2019 classification, assessed on the kidney graft biopsy
Time frame: at 12 months post biopsy
Serum creatinine and calculation of eGFR
Assessment of renal function based on serum creatinine levels and estimated glomerular filtration rate (eGFR), calculated using the CKD-EPI formula
Time frame: 12 months and 36 months post biopsy
Proteinuria/creatininuria ratio
Evaluation of proteinuria using the proteinuria-to-creatininuria ratio measured on urine samples
Time frame: 12 months and 36 months post biopsy
Significant Proteinuria
Proportion of patients presenting significant proteinuria, defined as a proteinuria-to-creatininuria ratio \> 0.5
Time frame: 12 months and 36 months post biopsy
Presence of Poor Prognostic Histological Features
Presence of unfavorable histological features, defined as transplant glomerulopathy with cg score \> 1 according to Banff 2019 classification
Time frame: 12 months post biopsy
Biopsy-Proven Acute T Cell-Mediated Rejection
Incidence of biopsy-proven acute T cell-mediated rejection, classified according to the Banff 2019 criteria
Time frame: From biopsy to 36 months post biopsy
Donor-Specific Antibody (DSA) Mean Fluorescence Intensity (MFI)
Assessment of DSA MFI measured using a Luminex single antigen assay at 12 months post-V0 and collected from medical charts at 36 months post-randomization
Time frame: 12 months post-biopsy and 36 months post-randomization
Insufficient Reduction in DSA MFI
Proportion of patients presenting a reduction in DSA MFI of less than 50% compared to baseline values.
Time frame: 12 months post biopsy
Evaluation of Safety Outcomes (Adverse Events)
Collection and analysis of adverse events, including but not limited to viral reactivations (BK virus, CMV, EBV viremia), cardiovascular events, and other clinically significant adverse events.
Time frame: Until the end of the study
Graft Loss and Death
Occurrence of graft loss and all-cause mortality, collected from medical charts.
Time frame: 12 months and 36 months post biopsy
Renal Function and Proteinuria According to Initial Biopsy Groups
Comparison of serum creatinine, eGFR (CKD-EPI), and proteinuria-to-creatininuria ratio between patient groups defined according to the initial biopsy findings.
Time frame: 12 months and 36 months post biopsy
Graft Loss and Death According to Initial Biopsy Groups
Comparison of graft loss and all-cause mortality between patient groups defined according to the initial biopsy findings.
Time frame: 12 months and 36 months post biopsy
Incidence Rate of de novo Subclinical ABMR (sABMR)
Incidence rate of biopsy-proven subclinical ABMR (sABMR), defined according to Banff 2019 classification, in patients without sABMR at initial biopsy. The incidence will be expressed as the number of patients developing sABMR divided by the time elapsed between the initial biopsy and the first biopsy demonstrating sABMR.
Time frame: From initial biopsy up to 12 months post biopsy
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University Hospital, Rouen