Fiche traitement
Kidney Transplant
Massachusetts General Hospital • Maladie rénale chronique
Suivi actif
Phase 1
Résumé
Kidney Transplant est développé par Massachusetts General Hospital. Le traitement est actuellement en Phase 1. Il est associé à Maladie rénale chronique. Son objectif thérapeutique principal est À vérifier. Le statut actuel est : suivi actif.
À vérifier
À vérifier
Phase 1
Massachusetts General Hospital
United States
Rationale:
Sodium glucose co transporter 2 (SGLT2) inhibitors are a relatively new class of agents, originally developed as oral antihyperglycemic drugs. SGLT2 inhibitors are clinically available since 2012 for the treatment of patients with diabetes mellitus type 2. Later, SGLT2 inhibitors appeared to have also specific reno- and cardioprotective effects. Remarkably, the trials that have been performed thus far excluded patients with an eGFR below 25 mL/min/1.73m2 at inclusion, prevalent dialysis patients, and kidney transplant recipients. This is unfortunate, because especially these patients are at high risk of reaching kidney failure requiring dialysis, cardiovascular complications and mortality, whereas there are only few proven effective therapies. There is emerging evidence from experimental studies and post hoc-analyses of randomized clinical trials that SGLT2 inhibitors may also be effective in preventing cardiovascular and mortality outcomes in these patients with severe CKD, including patients receiving dialysis or living with a kidney transplant. For instance, subgroup analysis of the DAPA-CKD trial comparing 624 patients with an eGFR\<30 to the remainder of the trial population with better kidney function, demonstrated that the efficacy of the SGLT2 inhibitor dapagliflozin in reducing cardiovascular, heart failure and renal outcomes persisted in the population with impaired kidney function. Furthermore, in the DAPA-CKD trial patients continued to use dapagliflozin or placebo when dialysis was initiated. In the subgroup of patients who initiated dialysis, dapagliflozin was associated with a relative risk reduction for mortality of 21%. Finally, in kidney transplant recipients, SGLT2 inhibitors have been shown to be effective in lowering HbA1c, body weight, blood pressure and stabilize kidney function, and these agents were well tolerated and safe. Taken these findings together there is a sound rationale to study the long-term reno- and cardioprotective efficacy and safety of SGLT2 inhibitors in patients with severe CKD.
There are two cardiac sub-studies: the cardiac magnetic resonance imaging (MRI) sub-study and the echocardiography sub-study. The echocardiography sub-study is referred to as the "SGLT-2-inhibitors to Target Heart Failure in Peritoneal Dialysis" (STOP-HF-in-PD) study.
2026-10-08
Début phase actuelle
Non disponible dans les sources synchronisées
Timeline clinique
Phase 1
Début phase actuelle
Non disponible dans les sources synchronisées
Préclinique
Phase 1
Phase 2
Phase 3
Approuvé
Objectif scientifique de l’étude
classification automatique vérifiable
À vérifier
Confiance automatique : 0%
Ce pourcentage n’est pas une probabilité de succès clinique.
Il mesure uniquement la force de la classification automatique de l’objectif scientifique. Le calcul part de 45 points, ajoute 7 points par unité de poids du mot-clé le plus fortement détecté, puis est plafonné à 95 %. Exemple : un score maximal de 2 donne 45 + (2 × 7) = 59 %.
Ce score est heuristique et doit être vérifié dans le protocole ou une publication.
Description affichée depuis l’essai compatible NCT05374291, afin d’éviter le mélange entre plusieurs indications d’une même molécule.
Contrôle de cohérence : 85/100
L’objectif est absent ou classé « Autre » et doit être recalculé à partir du protocole.
Transparence et qualité de la fiche
données vérifiablesClassificationÀ vérifier
Confiance de la fiche85 %
Source principaleSource officielle ou publication indexée
Dernière vérification2026-10-08
Anomalies détectées1
Validation humaineValidation humaine non effectuée
Donnée issue d’une source
Donnée normalisée automatiquement
Interprétation algorithmique
Classification scientifique multi-axes
ne pas confondre statut et résultatÉtat de l’étudeRecrutement en cours
Disponibilité des résultatsRésultats à vérifier
InterprétationImpossible à déterminer
Niveau de preuveNon évaluable
Un essai terminé n’est pas nécessairement positif. Un essai arrêté n’est classé comme échec scientifique que lorsqu’un résultat ou une raison explicite le confirme.
Indicateurs factuels
sans score subjectifPhase enregistréePhase 1
Études associées7
Publications associées16
Statut consolidéSuivi actif
Aucune chance de succès, note d’innovation, potentiel thérapeutique ou probabilité de commercialisation n’est calculé tant qu’un modèle validé et des données suffisantes ne sont pas disponibles.
Historique factuel de la molécule
39 événement(s) daté(s)Cette liste reprend uniquement les dates trouvées dans les registres et publications liés. Elle ne constitue pas une prévision.
| Date | Événement | Source |
|---|---|---|
| 2002-12-17 | Début de l’étudeNCT00050713 | Registre d’essai clinique |
| 2007-08-27 | Fin de l’étude prévue / enregistréeNCT00050713 | Registre d’essai clinique |
| 2022-11-08 | Début de l’étudeNCT05374291 | Registre d’essai clinique |
| 2024-07-24 | Début de l’étudeNCT05896839 | Registre d’essai clinique |
| 2026-01-28 | Début de l’étudeNCT07350837 | Registre d’essai clinique |
| 2026-02-04 | Début de l’étudeNCT07358195 | Registre d’essai clinique |
| 2026-05-22 | Début de l’étudeNCT07531966 | Registre d’essai clinique |
| 2026-07-10 | PublicationSafety and Effectiveness of Daratumumab in Recurrent and De Novo Focal Segmental Glomerulosclerosis After Kidney Transplant. | Kidney medicine |
| 2026-07-18 | PublicationImmunological Dynamics and Outcomes of ABO-Incompatible Kidney Transplants: Insights From a 5+-Year Follow-Up at a Transplant-Heavy Tertiary Center in Saudi Arabia. | Journal of transplantation |
| 2026-07-18 | PublicationAssociation between Torque teno virus-DNA plasma loads and post-transplantation diabetes mellitus in the first year after kidney transplantation. | BMC nephrology |
| 2026-07-18 | Publication36th International Symposium on Intensive Care and Emergency Medicine : Brussels, Belgium. 15-18 March 2016. | Critical care (London, England) |
| 2026-07-23 | PublicationRegulatory T cell modulation with selective CD28 blockade and IL-6 receptor antagonist in kidney transplant recipients: results of CTOT-24, a prospective clinical trial. | American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons |
| 2026-08-05 | Création de l’enregistrementNCT00050713 | Registre d’essai clinique |
| 2026-08-08 | PublicationA Custom-Built Intravoxel Incoherent Motion Diffusion Magnetic Resonance Imaging Tool for Renal Transplant Assessment: A Modular Graphical User Interface for Quantitative Biomarker Extraction. | Experimental and clinical transplantation : official journal of the Middle East Society for Organ Transplantation |
| 2026-08-13 | PublicationScleroderma Renal Crisis in Mixed Connective Tissue Disease. | The American journal of medicine |
| 2026-08-13 | PublicationBK Polyomavirus-Associated Nephropathy Complicated by Life-Threatening Hemorrhagic Pericardial Effusion Following Immunosuppression Reduction in a Kidney Transplant Recipient: A Case Report. | Case reports in transplantation |
| 2026-08-13 | PublicationEffects of Generic Prednisolone Formulations on the Dissolution Behavior of Mycophenolate Mofetil under Various pH Conditions. | Therapeutic innovation & regulatory science |
| 2026-08-13 | PublicationAnti-CD38/Anti-CD20 Rescue Therapy for Posttransplant Recurrent FSGS. | Kidney international reports |
| 2026-08-13 | PublicationAlemtuzumab Induction via Intravenous vs. Subcutaneous Administration in Pediatric Kidney Transplantation. | Pediatric transplantation |
| 2026-08-16 | PublicationTemporary mycophenolate discontinuation and reintroduction in pediatric kidney transplantation: predictors and long-term outcomes. | Pediatric nephrology (Berlin, Germany) |
| 2026-08-16 | PublicationCardiorespiratory fitness and left ventricular recovery after kidney transplantation: evidence, gaps, and future directions. | Renal failure |
| 2026-08-16 | PublicationEarly posttransplant rituximab use in kidney transplant recipients with preexisting donor-specific antibodies. | Renal failure |
| 2026-08-16 | PublicationKidney transplantation in sub-Sahara African countries: challenges and lessons from the experience of Cameroon: a preliminary report of the first 17 pioneer cases. | Renal failure |
| 2026-09-01 | Création de l’enregistrementNCT05896839 | Registre d’essai clinique |
| 2026-10-08 | Dernière mise à jour des donnéesKidney Transplant | Biomedical Watch |
| 2026-10-11 | Création de l’enregistrementNCT07350837 | Registre d’essai clinique |
| 2026-10-18 | Création de l’enregistrementNCT05374291 | Registre d’essai clinique |
| 2026-10-18 | Création de l’enregistrementNCT07358195 | Registre d’essai clinique |
| 2026-10-18 | Création de l’enregistrementNCT07877103 | Registre d’essai clinique |
| 2026-10-18 | Dernière mise à jour du registreNCT07531966 | Registre d’essai clinique |
| 2026-10-18 | Création de l’enregistrementNCT07531966 | Registre d’essai clinique |
| 2026-10-18 | PublicationEffects of dapagliflozin on proteinuria, glycemic control, and treatment burden in diabetic kidney transplant recipients: a matched cohort study. | Acta diabetologica |
| 2026-10-25 | Début de l’étudeNCT07877103 | Registre d’essai clinique |
| 2027-01-31 | Fin de l’étude prévue / enregistréeNCT05896839 | Registre d’essai clinique |
| 2027-07-01 | Fin de l’étude prévue / enregistréeNCT05374291 | Registre d’essai clinique |
| 2028-12-30 | Fin de l’étude prévue / enregistréeNCT07877103 | Registre d’essai clinique |
| 2029-12-31 | Fin de l’étude prévue / enregistréeNCT07350837 | Registre d’essai clinique |
| 2031-06-01 | Fin de l’étude prévue / enregistréeNCT07531966 | Registre d’essai clinique |
| 2031-12-01 | Fin de l’étude prévue / enregistréeNCT07358195 | Registre d’essai clinique |
Début phase actuelle
Non disponible dans les sources synchronisées
Essais cliniques liés
7 essai(s)
Début phase actuelle
Non disponible dans les sources synchronisées
| NCT | Titre | Phase | Statut administratif | Pays | Sponsor |
|---|---|---|---|---|---|
| NCT05374291 | The RENAL LIFECYCLE Trial: A RCT to Assess the Effect of Dapagliflozin on Renal and Cardiovascular Outcomes in Patients With Severe CKD | Phase 3 | ACTIVE_NOT_RECRUITING | Australia, Belgium, Germany, Netherlands, Singapore, Spain | University Medical Center Groningen |
| NCT07358195 | Addition of Venetoclax to Combined Hematopoietic Stem Cell and Kidney Transplantation | Phase 1 | RECRUITING | United States | Massachusetts General Hospital |
| NCT07877103 | Study on the Safety and Efficacy of a Time-of-Day-Based Individualized Tacrolimus Dosing Regimen in Kidney Transplant Recipients | Phase 4 | NOT_YET_RECRUITING | China | The First Affiliated Hospital of Guangzhou Medical University |
| NCT07531966 | DAN-PTRAIII — Vascular Complications After Kidney Transplantation | À vérifier | RECRUITING | Denmark | University of Aarhus |
| NCT07350837 | CAR-T Therapy Targeting CD19 and BCMA in Highly Sensitized Kidney Transplant Participants | Phase 1 | RECRUITING | China | Tongji Hospital |
| NCT05896839 | Immunotherapy in Combination With Prednisone and Sirolimus for Kidney Transplant Recipients With Unresectable or Metastatic Skin Cancer | Phase 1/2 | RECRUITING | United States | National Cancer Institute (NCI) |
| NCT00050713 | Sirolimus Therapy for Idiopathic and Lupus Membranous Nephropathy | Phase 2 | COMPLETED | United States | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Publications liées
16 publication(s)Publications liées
16 publication(s)| Titre | PMID | DOI | Journal | Date |
|---|---|---|---|---|
| Effects of dapagliflozin on proteinuria, glycemic control, and treatment burden in diabetic kidney transplant recipients: a matched cohort study. Voir source | 42675203 | 10.1007/s00592-026-02792-4 | Acta diabetologica | |
| Temporary mycophenolate discontinuation and reintroduction in pediatric kidney transplantation: predictors and long-term outcomes. Voir source | 41979713 | 10.1007/s00467-026-07231-8 | Pediatric nephrology (Berlin, Germany) | |
| Cardiorespiratory fitness and left ventricular recovery after kidney transplantation: evidence, gaps, and future directions. Voir source | 41772838 | 10.1080/0886022X.2026.2626621 | Renal failure | |
| Early posttransplant rituximab use in kidney transplant recipients with preexisting donor-specific antibodies. Voir source | 41582011 | 10.1080/0886022X.2026.2620179 | Renal failure | |
| Kidney transplantation in sub-Sahara African countries: challenges and lessons from the experience of Cameroon: a preliminary report of the first 17 pioneer cases. Voir source | 42315970 | 10.1080/0886022X.2026.2684370 | Renal failure | |
| Scleroderma Renal Crisis in Mixed Connective Tissue Disease. Voir source | 42562041 | 10.1016/j.amjmed.2026.07.029 | The American journal of medicine | |
| BK Polyomavirus-Associated Nephropathy Complicated by Life-Threatening Hemorrhagic Pericardial Effusion Following Immunosuppression Reduction in a Kidney Transplant Recipient: A Case Report. Voir source | 42529343 | 10.1155/crit/2999849 | Case reports in transplantation | |
| Effects of Generic Prednisolone Formulations on the Dissolution Behavior of Mycophenolate Mofetil under Various pH Conditions. Voir source | 42530850 | 10.1007/s43441-026-01027-6 | Therapeutic innovation & regulatory science | |
| Anti-CD38/Anti-CD20 Rescue Therapy for Posttransplant Recurrent FSGS. Voir source | 42571438 | 10.1016/j.ekir.2026.106668 | Kidney international reports | |
| Alemtuzumab Induction via Intravenous vs. Subcutaneous Administration in Pediatric Kidney Transplantation. Voir source | 42590956 | 10.1111/petr.70424 | Pediatric transplantation | |
| A Custom-Built Intravoxel Incoherent Motion Diffusion Magnetic Resonance Imaging Tool for Renal Transplant Assessment: A Modular Graphical User Interface for Quantitative Biomarker Extraction. Voir source | 42538664 | 10.6002/ect.MESOT2025.O27 | Experimental and clinical transplantation : official journal of the Middle East Society for Organ Transplantation | |
| Regulatory T cell modulation with selective CD28 blockade and IL-6 receptor antagonist in kidney transplant recipients: results of CTOT-24, a prospective clinical trial. Voir source | 42486389 | 10.1016/j.ajt.2026.07.016 | American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons | |
| Immunological Dynamics and Outcomes of ABO-Incompatible Kidney Transplants: Insights From a 5+-Year Follow-Up at a Transplant-Heavy Tertiary Center in Saudi Arabia. Voir source | 42403973 | 10.1155/joot/6265955 | Journal of transplantation | |
| Association between Torque teno virus-DNA plasma loads and post-transplantation diabetes mellitus in the first year after kidney transplantation. Voir source | 42420873 | 10.1186/s12882-026-05192-6 | BMC nephrology | |
| 36th International Symposium on Intensive Care and Emergency Medicine : Brussels, Belgium. 15-18 March 2016. Voir source | 27885969 | 10.1186/s13054-016-1208-6 | Critical care (London, England) | |
| Safety and Effectiveness of Daratumumab in Recurrent and De Novo Focal Segmental Glomerulosclerosis After Kidney Transplant. Voir source | 42239817 | 10.1016/j.xkme.2026.101384 | Kidney medicine |
Sources officielles
liens de rechercheDernière mise à jour des données : 2026-10-08
Ces sources sont proposées pour vérification. Les informations de la fiche doivent être confirmées dans les registres officiels ou les publications originales.