tacrolimus intravenous / Generic mfg. - LARVOL DELTA

Neuro-KTR: Neurocognitive Function Changes With Extended-Release Tacrolimus Among Older Kidney Transplant Recipients (clinicaltrials.gov) - P4 | N=92 | Recruiting | Sponsor: Massachusetts General Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Transplantation

ABCC2 rs2273697 is an independent determinant of tacrolimus intra-patient variability during the first year after kidney transplantation. (PubMed, Int J Clin Pharm) - "CYP3A5 genotyping remains valuable for optimizing initial tacrolimus dosing, while ABCC2 polymorphisms, particularly rs2273697, contribute to tacrolimus C0-IPV during the first post-transplant year. Personalized dosing strategies using pharmacogenetic data could improve tacrolimus exposure stability. Larger studies with extended follow-up are needed to assess the long-term clinical implications of these findings."

Journal • Transplantation • ABCC2 • CYP3A5

RC24-0546: IL-1? blockade to prevent Immunothrombosis in recipients of a Pancreatic Organ (ILIPO) (clinicaltrialsregister.eu) - P1/2 | N=15 | Not yet recruiting | Sponsor: Centre Hospitalier Universitaire De Nantes

New P1/2 trial • Diabetes • Hematological Disorders • Metabolic Disorders • Thrombosis • Transplantation

NCI-2019-03188: Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS) (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Fred Hutchinson Cancer Center | Trial completion date: Dec 2028 ➔ Dec 2029 | Trial primary completion date: Dec 2026 ➔ Dec 2027

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Chronic Myeloid Leukemia • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Mast Cell Leukemia • Myelodysplastic Syndrome • Myeloproliferative Neoplasm • Oncology • Transplantation • HLA-B • HLA-C • HLA-DQB1 • HLA-DRB1

De-escalated Cyclophosphamide (PTCy) and Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis (clinicaltrials.gov) - P2 | N=56 | Active, not recruiting | Sponsor: Medical College of Wisconsin | Suspended ➔ Active, not recruiting

Enrollment closed • Graft versus Host Disease • Hodgkin Lymphoma • Immunology • Myelodysplastic Syndrome • HLA-B • HLA-C • HLA-DRB1

Treosulfan-Based Conditioning Regimen Before a Blood or Bone Marrow Transplant for the Treatment of Bone Marrow Failure Diseases (BMT CTN 1904) (clinicaltrials.gov) - P2 | N=40 | Completed | Sponsor: Fred Hutchinson Cancer Center | Active, not recruiting ➔ Completed

Trial completion • Anemia • Aplastic Anemia • Bone Marrow Transplantation • Complement-mediated Rare Disorders • Genetic Disorders • Hematological Disorders • Hematological Malignancies • Myelodysplastic Syndrome • Neutropenia • Oncology • Paroxysmal Nocturnal Hemoglobinuria • Rare Diseases • Thrombocytopenia • Transplantation • GATA2 • HLA-B • HLA-C • HLA-DQB1 • HLA-DRB1

NCI-2020-01626: Peritransplant Ruxolitinib for Patients With Primary and Secondary Myelofibrosis (clinicaltrials.gov) - P2 | N=53 | Active, not recruiting | Sponsor: Fred Hutchinson Cancer Center | N=79 ➔ 53

Enrollment change • Myelofibrosis • Transplantation

Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P2 | N=97 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jan 2026 ➔ Jan 2027

Trial completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • T Acute Lymphoblastic Leukemia • Transplantation • ABL1 • ANPEP • BCR • CD22 • CD5 • CD7 • CD79A • MME • MPO

A Blood Stem Cell Transplant for Sickle Cell Disease (clinicaltrials.gov) - P1 | N=3 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Feb 2026 ➔ Jan 2027 | Trial primary completion date: Feb 2026 ➔ Jan 2027

Trial completion date • Trial primary completion date • Anemia • Genetic Disorders • Hematological Disorders • Sickle Cell Disease • Transplantation • HLA-B • HLA-C • HLA-DRB1

Immunosuppressive Drugs and Gut Microbiome: Pharmacokinetic- and Microbiome Diversity Effects (clinicaltrialsregister.eu) - P4 | N=100 | Recruiting | Sponsor: Oslo University Hospital HF | Not yet recruiting ➔ Recruiting

Enrollment open • Transplantation

CalciTx: CALCIGRAN FORTE AND DOSING OF IMMUNOSUPPRESSIVE DRUGS IN KIDNEY TRANSPLANT RECIPIENTS (clinicaltrialsregister.eu) - P4 | N=26 | Completed | Sponsor: Oslo University Hospital HF | Not yet recruiting ➔ Completed

Trial completion • Transplantation

GenIS-BID: Immunosuppressive drug bioequivalence in kidney transplant recipients Prograf and CellCept (clinicaltrialsregister.eu) - P4 | N=27 | Completed | Sponsor: Oslo University Hospital HF | Not yet recruiting ➔ Completed

Trial completion • Transplantation

Low-Grade Spindle Cell Neoplasm as the Presenting Sign of Epstein-Barr Virus Associated Smooth Muscle Cell Tumor in a Kidney Transplant (NKF-SCM 2026) - "His medications of prednisone and tacrolimus were continued, and mycophenolate mofetil was held...Sirolimus replaced mycophenolate, and prograf was decreased by 50%...Management involves decreasing immunosuppression, possible surgical resection, and switching to mTOR inhibitors to treat EBV which may risk graft rejection and loss. Emerging therapies include chemotherapy and EBV specific T cell therapies."

Diabetes • Diabetic Nephropathy • Epstein-Barr Virus Infections • Infectious Disease • Kidney Cancer • Metabolic Disorders • Nephrology • Oncology • Spindle Cell Sarcoma • Transplant Rejection • Transplantation • Type 2 Diabetes Mellitus • ANO1 • BCL2

Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From Prograf® to Advagraf® (clinicaltrials.gov) - P2 | N=81 | Active, not recruiting | Sponsor: Astellas Pharma Europe Ltd. | Trial primary completion date: Jun 2026 ➔ Oct 2015

Trial primary completion date • Pediatrics • Transplantation

Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From Prograf® to Advagraf® (clinicaltrials.gov) - P2 | N=81 | Active, not recruiting | Sponsor: Astellas Pharma Europe Ltd. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Dec 2016 ➔ Jun 2026

Enrollment closed • Trial primary completion date • Pediatrics • Transplantation

Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From Prograf® to Advagraf® (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: Astellas Pharma Europe Ltd. | Trial primary completion date: Nov 2015 ➔ Dec 2016

Trial primary completion date • Pediatrics • Transplantation

Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From Prograf® to Advagraf® (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: Astellas Pharma Europe Ltd. | Trial primary completion date: Jun 2015 ➔ Nov 2015

Trial primary completion date • Pediatrics • Transplantation

Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From Prograf® to Advagraf® (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: Astellas Pharma Europe Ltd. | Trial primary completion date: Dec 2014 ➔ Jun 2015

Trial primary completion date • Pediatrics • Transplantation

Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From Prograf® to Advagraf® (clinicaltrials.gov) - P2 | N=81 | Active, not recruiting | Sponsor: Astellas Pharma Europe Ltd. | Trial completion date: May 2026 ➔ Dec 2025

Trial completion date • Pediatrics • Transplantation

BRUNO-PIC: Utilising Genotype Informed Bayesian Dosing of Tacrolimus in Children Post Solid Organ Transplantation. (clinicaltrials.gov) - P4 | N=45 | Recruiting | Sponsor: Murdoch Childrens Research Institute | Phase classification: P2 ➔ P4

Biomarker • Phase classification • Solid Organ Transplantation • Transplantation

Total Marrow and Lymphoid Irradiation Before Donor Transplant and Cyclophosphamide in Treating Patients With Acute Myeloid Leukemia (clinicaltrials.gov) - P1 | N=56 | Suspended | Sponsor: City of Hope Medical Center | N=18 ➔ 56 | Trial completion date: Apr 2026 ➔ Sep 2026 | Recruiting ➔ Suspended | Trial primary completion date: Apr 2026 ➔ Sep 2026

Enrollment change • Trial completion date • Trial primary completion date • Trial suspension • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Oncology • Transplantation

The importance of staying within range: associations between tacrolimus intrapatient variability and kidney transplant outcomes. (PubMed, Front Immunol) - "High tacrolimus IPV (≥30%) was associated with a 2.4-fold increased risk of rejection (95% CI 1.3-4.6; P=0.009)...Multiple markers of tacrolimus underexposure were independently associated with poor post-transplant outcomes. These findings underscore the critical importance of maintaining tacrolimus levels within the target therapeutic range during the early post-transplant period to optimize long-term kidney transplant outcomes."

Journal • Retrospective data • Chronic Kidney Disease • Nephrology • Transplant Rejection • Transplantation

ECP-DL Cell Infusion for Induction in Living Donor Kidney (LDK) Transplants (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Northwestern University | Initiation date: Sep 2025 ➔ Mar 2026 | Trial primary completion date: Aug 2027 ➔ Dec 2027

Trial initiation date • Trial primary completion date • Transplant Rejection • Transplantation

Evaluating the IV-to-PO Conversion Ratio of Intermittent IV Bolus Tacrolimus in Pediatric Allogeneic HCT (TCT-ASTCT-CIBMTR 2026) - "In pediatric HCT patients receiving twice-daily IV bolus tacrolimus, an IV-to-PO conversion ratio of approximately 1:3 achieved therapeutic levels with minimal toxicity. These findings suggest that lower conversion ratios than those previously published for continuous infusion may be appropriate and warrant validation in larger, prospective studies. 1."

Clinical • Acute Graft versus Host Disease • Acute Kidney Injury • Graft versus Host Disease • Immunology • Nephrology • Pediatrics • Renal Disease

Radiation- and Alkylator-free Bone Marrow Transplantation Regimen for Patients With Dyskeratosis Congenita (clinicaltrials.gov) - P2 | N=40 | Active, not recruiting | Sponsor: Boston Children's Hospital | Trial primary completion date: Jul 2025 ➔ Jul 2026

Trial primary completion date • Anemia • Aplastic Anemia • Bone Marrow Transplantation • Hematological Disorders • Transplantation • DKC1 • HLA-B • HLA-C • HLA-DRB1 • RTEL1 • TERT • ZCCHC8