tacrolimus intravenous / Generic mfg. - LARVOL DELTA

FK506 improves B cell reconstitution after allo-HSCT compared to csa: A real-world study (ASH 2025) - "Calcineurin inhibitors(CNIs), including Cyclosporine A (CsA) and Tacrolimus (FK506), are widely used immunosuppressiveagents in allo-HSCT...Prophylaxis regimens included either tacrolimus (FK506, administered at 0.05mg/kg twice daily intravenously, adjusted to maintain a trough level of 5–15 ng/mL) or cyclosporine (CsA,administered at 3.0 mg/kg/day intravenously from day −1, adjusted to maintain a trough level of 200–300ng/mL)...Additionally, we observed a potential association between bonemarrow B-cell recovery around day +100 and viral infections. Through mediation analysis, we furtherexplored the relationship between FK506, B-cell reconstitution, and viral infection, revealing that B cellsplayed a mediating role in the impact of FK506 on post-transplant viral infection."

Clinical • Real-world • Real-world evidence • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Disorders • Immunology • Infectious Disease

New-onset anti-melanoma differentiation-associated gene 5 antibody positive clinically amyopathic dermatomyositis following COVID-19: A case report. (PubMed, Intern Med) - "We herein report a case of an older Japanese patient who presented with skin rash, relapsing progressive interstitial lung disease, and anti-melanoma differentiation-associated gene 5 (anti-MDA5) antibody seropositivity after COVID-19 infection. Although the patient was elderly, her symptoms improved with the administration of corticosteroids, tacrolimus, and intravenous cyclophosphamide, indicating that this combination may be a viable treatment option for anti-MDA5 antibody-positive pneumonia, which is a complication of COVID-19."

Journal • Dermatology • Dermatomyositis • Immunology • Infectious Disease • Interstitial Lung Disease • Melanoma • Myositis • Novel Coronavirus Disease • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor • IFIH1

Islet Transplantation in Patients With "Brittle" Type I Diabetes (clinicaltrials.gov) - P=N/A | N=20 | Recruiting | Sponsor: University of Chicago | Trial primary completion date: Sep 2025 ➔ Jun 2030

Trial primary completion date • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Transplantation • Type 1 Diabetes Mellitus

Allogenic Islet Cell Transplantation (clinicaltrials.gov) - P1/2 | N=50 | Active, not recruiting | Sponsor: University of Chicago | Trial completion date: Oct 2025 ➔ Oct 2030 | Trial primary completion date: Oct 2025 ➔ Oct 2030

Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Transplantation • Type 1 Diabetes Mellitus

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

Trial completion • Pediatrics • Transplantation

Islet Transplantation in Type 1 Diabetic Kidney Allograft (clinicaltrials.gov) - P2 | N=10 | Recruiting | Sponsor: University of Chicago | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Diabetes • Diabetic Nephropathy • Metabolic Disorders • Transplantation • Type 1 Diabetes Mellitus

Fib and Flow: Fibrillary Deposits in the Wake of Myeloproliferative Disease (KIDNEY WEEK 2025) - "The patient was enrolled in a clinical trial for ruxolitinib and selinexor...Tacrolimus and intravenous rituximab [2 doses of 1g two weeks apart] were administered due to nonresponse to conservative management...Treatment is largely supportive, with disease-directed therapy potentially offering some benefit. Increased awareness among clinicians and nephrologists is needed to better understand the disease course natural and optimize management of this rare condition."

Atherosclerosis • Cardiovascular • Chronic Eosinophilic Leukemia • Fibrosis • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Hematological Disorders • Hypertension • Immunology • Lupus Nephritis • Myelofibrosis • Myeloproliferative Neoplasm • Nephrology • Renal Disease

Neuro-KTR: Neurocognitive Function Changes With Extended-Release Tacrolimus Among Older Kidney Transplant Recipients (clinicaltrials.gov) - P4 | N=92 | Not yet recruiting | Sponsor: Massachusetts General Hospital | Initiation date: May 2025 ➔ Dec 2025

Trial initiation date • Transplantation

Ruxolitinib Before, During and After Hematopoietic Cell Transplant in Older Patients With Myelofibrosis and Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes (clinicaltrials.gov) - P2 | N=50 | Not yet recruiting | Sponsor: Fred Hutchinson Cancer Center

New P2 trial • Hematological Malignancies • Myelodysplastic Syndrome • Myelofibrosis • Myeloproliferative Neoplasm • Oncology • Transplantation

Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia (clinicaltrials.gov) - P2 | N=72 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Oct 2025 ➔ Sep 2026

Trial completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • T Acute Lymphoblastic Leukemia • Transplantation • HLA-B • HLA-C

Association between tacrolimus intrapatient variability and clinical outcomes in kidney transplantation: a retrospective cohort study. (PubMed, Transl Androl Urol) - "The effect of tacrolimus IPV on Chinese kidney transplantation outcomes is unclear, and the aim of this study is to explore the association between IPV and poorer outcomes of Chinese kidney transplantation recipients and to discuss the influence of genotype...IPV is associated with clinical outcomes such as AR in Chinese kidney transplantation recipients. More attention should be paid to the association between high IPV and adverse outcomes in CYP3A5 nonexpresser recipients."

Clinical data • Journal • Retrospective data • Endocrine Disorders • Hematological Disorders • Infectious Disease • Leukopenia • Transplant Rejection • Transplantation • CYP3A5

Comparison of Immediate- and Extended-Release Tacrolimus Formulations in Living-Donor Kidney Transplantation (LDKT) (KIDNEY WEEK 2025) - "Funding Commercial Support – Veloxis Pharmaceutical, Inc Background Standard maintenance immunosuppression in LDKT typically includes tacrolimus, mycophenolate mofetil (MMF), and ±steroids. In IPW-adjusted Cox models, compared to the Prograf reference group, there were no statistically significant differences in ACGF risk (Generic Tacrolimus: HR=1.13, 95% CI: 0.97–1.33, p =0.12; Envarsus XR: HR=0.98, 95% CI: 0.73–1.30, p =0.88) or in DCGF risk (Generic Tacrolimus: HR=1.09, 95% CI: 0.84–1.42, p = 0.51; Envarsus XR: HR=0.85, 95% CI: 0.55–1.33, p =0.48). Conclusion Envarsus XR demonstrates non-inferiority to IR-Tac formulations with respect to acute rejection and graft failure outcomes in LDKT."

Pediatrics • Transplant Rejection • Transplantation

Comparison of Immediate- and Extended-Release Tacrolimus Formulations in Deceased-Donor Kidney Transplantation (DDKT) (KIDNEY WEEK 2025) - "Funding Commercial Support – Veloxis Pharmaceuticals, Inc Background Standard maintenance immunosuppression in DDKT typically includes tacrolimus, mycophenolate mofetil (MMF), and ±steroids. In IPW-adjusted Cox models, compared to the Prograf reference group, there were no statistically significant differences in ACGF risk (Generic Tacrolimus: HR=0.95, 95% CI: 0.87–1.02, p =0.17; Envarsus XR: HR=0.90, 95% CI: 0.81–1.00, p =0.06) or in DCGF risk (Generic Tacrolimus: HR=0.95, 95% CI: 0.86–1.05, p =0.35; Envarsus XR: HR=0.93, 95% CI: 0.80–1.09, p =0.40). Conclusion Envarsus XR demonstrates non-inferiority to IR-Tac formulations with respect to acute rejection and graft failure outcomes in DDKT."

Pediatrics • Transplant Rejection • Transplantation

Association of Tacrolimus Intrapatient Variability and One-Year Outcome in Kidney Transplant Patients of National Kidney and Transplant Institute, January 2016-December 2020: A Retrospective Study (KIDNEY WEEK 2025) - "The findings underscore the significance of maintaining stable Tacrolimus exposure. Monitoring and minimizing Tacrolimus IPV may serve as a modifiable factor to improve kidney transplant outcomes."

Retrospective data • Transplant Rejection • Transplantation

Successful methotrexate and rituximab combination therapy for a Taiwanese patient with anti-signal recognition particle antibody-positive immune-mediated necrotizing myopathy: A case report. (PubMed, Mod Rheumatol Case Rep) - "High-dose glucocorticoids, tacrolimus, and intravenous immunoglobulins were administered. By day 200, her creatine kinase level had improved, and she was weaned off the ventilator. Herein, we report the case of a Taiwanese East Asian patient with anti-SRP antibody-positive IMNM who was refractory to conventional therapy and was successfully treated with MTX and rituximab."

Journal • Dermatology • Gastrointestinal Disorder • Musculoskeletal Pain • Myositis • Pain

De-escalated Cyclophosphamide (PTCy) and Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis (clinicaltrials.gov) - P2 | N=56 | Suspended | Sponsor: Medical College of Wisconsin | Trial completion date: Sep 2025 ➔ Sep 2026 | Recruiting ➔ Suspended | Trial primary completion date: Sep 2025 ➔ Sep 2026

Trial completion date • Trial primary completion date • Trial suspension • Graft versus Host Disease • Immunology • Myelodysplastic Syndrome • HLA-B • HLA-C • HLA-DRB1

ANCA-ASSOCIATED VASCULITIS AFTER SECOND KIDNEY TRANSPLANT: A CASE OF DIFFUSE ALVEOLAR HEMORRHAGE AND GRAFT DYSFUNCTION (CHEST 2025) - "and chemotherapy including Cytoxan 600 mg, weekly 60 mg doxorubicin for 12 weeks, and daily 80 mg Paclitaxel, along with adjuvant radiation therapy. Her immunosuppressive therapy for DDKT maintenance was adjusted to 1 mg of Prograf BID and daily 5 mg of prednisone following cancer treatment.She presented to the ED in 3/2022 for fatigue, nausea, vomiting, chest pain, dyspnea, and a worsening cough for the last month...She was put back on immunosuppressive therapy consisting of Mycophenolate mofetil 250 mg BID and Tacrolimus 1 mg BID before being discharged to a rehab facility...With the significant past exposure and the myriad of side effects associated with it, the medical decision to not utilize cyclophosphamide, and use rituximab were warranted. De novo AAV after kidney transplantation is an exceptionally rare event. AAV with renal allograft involvement carries a significant risk of graft loss and comorbidities even with aggressive immunosuppression therapy."

Clinical • ANCA Vasculitis • Breast Cancer • Chronic Kidney Disease • Cough • Dyslipidemia • Endocrine Disorders • Fatigue • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Hypertension • Nephrology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Transplant Rejection • Transplantation • Triple Negative Breast Cancer • Vasculitis • MPO

Two Step Haplo With Radiation Conditioning (clinicaltrials.gov) - P2 | N=63 | Recruiting | Sponsor: Thomas Jefferson University | Suspended ➔ Recruiting

Enrollment open • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Adult T-Cell Leukemia-Lymphoma • Anemia • Aplastic Anemia • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Chronic Myelomonocytic Leukemia • Essential Thrombocythemia • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Multiple Myeloma • Myelodysplastic Syndrome • Myelofibrosis • Myeloproliferative Neoplasm • Non-Hodgkin’s Lymphoma • Oncology • Polycythemia Vera • Small Lymphocytic Lymphoma • Thrombocytosis • Transplantation

UNVEILING THE ENIGMATIC CULPRIT: AMYOPATHIC DERMATOMYOSITIS IN RAPIDLY PROGRESSIVE INTERSTITIAL LUNG DISEASE (CHEST 2025) - "Despite using steroids, cyclophosphamide, tacrolimus, intravenous immunoglobulins, and broad-spectrum antimicrobials patient's respiratory failure rapidly progressed resulting in his death.Patient B was a 44-year-old female on rituximab for neuromyelitis optica spectrum disorder...Despite initial treatment with fluticasone-salmeterol and oral prednisone her dyspnea worsened, and a repeat chest CT showed progression in her ground-glass opacities with septal thickening...Despite the success rates associated with the combined use of tacrolimus, cyclophosphamide and steroids, some case reports reported the use of mycophenolate mofetil as a single agent, which has not yielded comparable outcomes... Given the prognosis and rapid clinical decline in patients with positive anti-MDA5 antibodies, initial testing with a full ILD panel for new onset interstitial lung disease should be considered. Early detection of this antibody will trigger aggressive treatment early in the..."

CNS Disorders • Cough • Dermatomyositis • Immunology • Infectious Disease • Interstitial Lung Disease • Melanoma • Meningococcal Infections • Myositis • Neuromyelitis Optica Spectrum Disorder • Pneumonia • Pulmonary Disease • Rare Diseases • Respiratory Diseases • Rheumatology • Solid Tumor • IFIH1

AT-1501-K207: Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation (clinicaltrials.gov) - P2 | N=127 | Completed | Sponsor: Eledon Pharmaceuticals | Active, not recruiting ➔ Completed | Trial completion date: Mar 2025 ➔ Sep 2025 | Trial primary completion date: Mar 2025 ➔ Sep 2025

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

Evaluation of clinical and safety outcomes of generic tacrolimus (Suprotac ®) versus branded tacrolimus (Prograf ®) in de novo liver transplant patients: a randomized clinical trial. (PubMed, Daru) - "The findings of this study indicate that de novo use of Suprotac®, compared to Prograf®, offers comparable efficacy in preventing rejection and a similar one-year safety profile in adult liver transplant recipients."

Clinical • Journal • CNS Disorders • Insomnia • Pain • Sleep Disorder • Transplantation

Single-nucleotide polymorphisms of donor CYP3A5 and recipient ABCB1 affect tacrolimus intrapatient variability in living donor liver transplantation: a retrospective cohort study. (PubMed, Ann Surg Treat Res) - "SNPs of donor CYP3A5 and recipient ABCB1 can significantly influence tacrolimus IPV in patients undergoing living donor LT. Identifying these SNPs can help determine high IPV-prone patients, facilitate close monitoring of high IPV-susceptible groups, and improve outcomes."

Journal • Retrospective data • Transplantation • ABCB1 • ABCC2 • CYP3A5

Inotuzumab Ozogamicin and Chemotherapy in Treating Patients With Leukemia or Lymphoma Undergoing Stem Cell Transplantation (clinicaltrials.gov) - P2 | N=15 | Terminated | Sponsor: M.D. Anderson Cancer Center | N=44 ➔ 15 | Trial completion date: Mar 2027 ➔ Oct 2025 | Recruiting ➔ Terminated | Trial primary completion date: Mar 2027 ➔ Oct 2025; <75% participation

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • Transplantation • CD22 • HLA-B • HLA-C • HLA-DRB1

PTAAK: Pulse Wave Velocity, Tacrolimus Time in Therapeutic Range and CV in African American Kidney Transplants (clinicaltrials.gov) - P4 | N=60 | Active, not recruiting | Sponsor: Roy D. Bloom, MD | Trial completion date: Jan 2026 ➔ May 2026 | Trial primary completion date: Aug 2025 ➔ Feb 2026

Trial completion date • Trial primary completion date • Transplantation

A Two Step Approach to Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematologic Malignancies-Increasing GVT Effects Without Increasing Toxicity (clinicaltrials.gov) - P2 | N=51 | Active, not recruiting | Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University | Recruiting ➔ Active, not recruiting

Enrollment closed • Bone Marrow Transplantation • Hematological Malignancies • Oncology • Transplantation