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Home › Medications › tacrolimus

tacrolimus

9 published articles · Updated continuously

Clinical Trial Landscape

Clinical Trials of tacrolimus

195 trials tracked of tacrolimus: 59 in phase 3 or 4 and 15 with published results. The most-cited published study has 595 citations.

195Trials tracked
59Phase 3 & 4
0Recruiting
15With published results
Phase distribution
Phase 4 34 Phase 3 25 Phase 2 120 Phase 1 5 Other / NA 11
  1. Phase 3 TAC/MTX vs. TAC/MMF/PTCY for Prevention of Graft-versus-Host Disease and Microbiome and Immune Reconstitution Study (BMT CTN 1703/1801) Completed · 595 cited
  2. Phase 3 Tacrolimus and Methotrexate With or Without Sirolimus in Preventing Graft-Versus-Host Disease in Young Patients Undergoing Donor Stem Cell Transplant for Acute Lymphoblastic Leukemia in Complete Remission Completed · 227 cited
  3. Phase 3 Calcineurin Inhibitor-Free Interventions BMT CTN 1301 for Prevention of Graft-versus-Host Disease (BMT CTN 1301) Completed · 179 cited
  4. Phase 3 Campath, Calcineurin Inhibitor Reduction and Chronic Allograft Nephropathy Completed · 151 cited
  5. Phase 3 A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based Completed · 103 cited
  6. Phase 3 Investigation in Myositis-associated Pneumonitis of Prednisolone And Concomitant Tacrolimus Completed · 46 cited
Show 44 more trials
  1. Phase 4 Mycophenolate Mofetil and Tacrolimus Versus Tacrolimus for the Treatment of Idiopathic Membranous Glomerulonephritis Completed · 39 cited
  2. Phase 4 Belatacept Early Steroid Withdrawal Trial Completed · 36 cited
  3. Phase 4 Prospective Study Comparing Brand and Generic Immunosuppression on Transplant Outcomes, Adherence, & Immune Response in Kidney Transplant Recipients Completed · 34 cited
  4. Phase 4 Efficacy of Everolimus in Combination With Tacrolimus in Liver Transplant Recipients Completed · 30 cited
  5. Phase 4 Tacrolimus Versus Prednisolone for the Treatment of Minimal Change Disease Completed · 20 cited
  6. Phase 3 12 Month Athena Study: Everolimus vs. Standard Regimen in de Novo Kidney Transplant Patients Completed · 13 cited
  7. Phase 3 Tac, Mini-MTX, MMF Versus Tac, MTX for GVHD Prevention Completed · 11 cited
  8. Phase 4 Envarsus in Delayed Graft Function (E-DGF) Completed · 3 cited
  9. Phase 4 Use of Sublingual Tacrolimus in Adult Blood and Marrow Transplant Patients Completed
  10. Phase 4 Study of Liver Transplant For End-Stage Liver Disease Caused By Chronic Hepatitis C Infection Completed
  11. Phase 4 Immunosuppression Impact on the Metabolic Control of Kidney Transplant With Pre-Existing Type 2 Diabetes (DM) Completed
  12. Phase 4 Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in Children Completed
  13. Phase 4 Comparison of a Tacrolimus Hexal® Based Regimen Versus a Prograf® Based Regimen in de Novo Renal Transplant Recipients Completed
  14. Phase 4 Belatacept Compared to Tacrolimus in Deceased Donor Renal Transplant Recipients Completed
  15. Phase 4 To Compare the Effects of Immediate-release Tacrolimus and Astagraf XL on Donor-Specific Antibody (DSA) Formation and the Development of Immune Activation (IA) in de Novo Kidney Transplant Recipients Completed
  16. Phase 4 Kidney Biopsy Controlled Trial of Calcineurin Inhibitor Withdrawal Completed
  17. Phase 4 Belatacept 3 Month Post Transplant Conversion Study Completed
  18. Phase 4 Study of Pharmacogenomic-Guided Tacrolimus Dosing and Monitoring in Kidney Transplant Recipients Completed
  19. Phase 4 Safety and Efficacy of Basiliximab, Delayed Dose Tacrolimus Plus ECMPA (Enteric Coated Mycophenolic Acid) Following Liver Transplantation Completed
  20. Phase 4 Envarsus on the Effect of Total Tacrolimus Dose/Trough Level Ratio on Renal Function (eGFR) in Kidney Transplantation Completed
  21. Phase 4 Conversion From Brand to Generic Tacrolimus in High Risk Transplant Recipients Completed
  22. Phase 4 A Safety and Efficacy Study of Prograf in the Prevention of Erectile Dysfunction After Radical Prostatectomy Completed
  23. Phase 4 Improved Induction and Maintenance Immunosuppression in Kidney Transplantation Completed
  24. Phase 4 A Study Comparing the Withdrawal of Steroids or Tacrolimus in Kidney Transplant Recipients Completed
  25. Phase 4 Liver Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Sirolimus in Recipients of a Liver Transplant Completed
  26. Phase 4 Optima: Optimizing Prograf Therapy in Maintenance Allografts II Completed
  27. Phase 4 Safety Outcomes of Lower Immunosuppression Versus Traditional Immunosuppression in Heart Transplant Recipients Completed
  28. Phase 4 Study Evaluating A Planned Transition From Tacrolimus To Sirolimus In Kidney Transplant Recipients Completed
  29. Phase 4 A Twelve-month, Multicenter, Open-label, Randomized Study of the Safety, Tolerability and Efficacy of Everolimus With Basiliximab, Corticosteroids and Two Different Exposure Levels of Tacrolimus in de Novo Renal Transplant Recipients Completed
  30. Phase 4 Single Center Pilot Study of Corticosteroid Discontinuation in Liver Transplant Recipients Completed
  31. Phase 4 A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Liver Transplant Patients. Completed
  32. Phase 4 Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients Completed
  33. Phase 4 Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation Completed
  34. Phase 4 Steroid Free Immunosuppression in Liver Transplantation Completed
  35. Phase 4 Cyclosporine A C-2h Monitoring Versus Tacrolimus C-0h Monitoring in de Novo Liver Transplant Recipients Completed
  36. Phase 4 24 Months Follow-up, Two Arm Study to Compare the Cardiovascular Profile in a Regimen With Everolimus + Mycophenolic Acid (MPA) Versus (vs.) a Regimen of CNI+MPA in Maintenance Renal Transplant Recipients Completed
  37. Phase 3 A National Multi-center Randomized, Open Label Study to Evaluate Efficacy and Safety of Everolimus With EC-MPS Compared to Standard Treatment Combination Tacrolimus and EC-MPS in de Novo Liver Transplant Recipients Completed
  38. Phase 3 Tacrolimus/Everolimus Versus Tacrolimus/Enteric-Coated Mycophenolate Sodium Completed
  39. Phase 3 Induction Therapy Study in Live Donor Kidney Transplant Recipients With a Positive Crossmatch Completed
  40. Phase 3 A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA) Completed
  41. Phase 3 REnal Function in Liver Transplantation: Everolimus With Calcineurin Inhibitor (CNI)-Sparing sTrategy Completed
  42. Phase 3 Fludarabine-IV Busulfan ± Clofarabine and Allogeneic Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Completed
  43. Phase 3 Extended Release Tacrolimus vs. Twice-Daily Tacrolimus Completed
  44. Phase 3 Enteric-coated Mycophenolate Sodium (EC-MPS) With Reduced-dose Tacrolimus Versus EC-MPS With Standard-dose Tacrolimus in Stable Kidney Transplant Recipients Completed

Showing the 50 most-cited and recently-updated of 195 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.
Platelet-rich plasma, autologous serum, and cyclosporine A show specific benefits in Sjögren's syndrome dry eye
Allergy & Immunology Meta-analysis
Platelet-rich plasma, autologous serum, and cyclosporine A show specific benefits in Sjögren's syndrome dry eye Topical Eye Treatments Show Different Benefits for Sjögren's Dry Eyes
This systematic review and network meta-analysis evaluated topical ocular therapies for Sjögren's syndrome-related dry eye disease. The anal…
New research identifies specific eye drops and treatments that may help different aspects of dry eyes caused by Sjögren's syndrome.
Frontiers Aug 26, 2026
Machine learning supports individualized tacrolimus dosing but lacks long-term dynamic regulation
Drug Pipeline Sys. Review
Machine learning supports individualized tacrolimus dosing but lacks long-term dynamic regulation Machine learning helps tailor tacrolimus doses for transplant patients
This narrative review examines machine learning (ML) applications for tacrolimus dosing in liver and kidney transplant patients. ML integrat…
New machine learning tools can help doctors personalize tacrolimus dosing for liver and kidney transplant patients by looking at many differ…
Frontiers Aug 23, 2026
Tacrolimus significantly reduces urine protein compared to MMF, placebo, and intravenous cyclophosphamide
Rheumatology Meta-analysis
Tacrolimus significantly reduces urine protein compared to MMF, placebo, and intravenous cyclophosphamide Tacrolimus shows promise for managing specific kidney markers in lupus nephritis
This meta-analysis of 1187 patients with lupus nephritis evaluates the efficacy and safety of tacrolimus. Findings indicate significant redu…
New data suggests tacrolimus can help lower protein levels in the urine and improve certain blood markers for patients with lupus nephritis.
Aug 3, 2026
Mycophenolate mofetil combined with conventional therapy offers best balance of efficacy and safety
Infectious Disease Meta-analysis
Mycophenolate mofetil combined with conventional therapy offers best balance of efficacy and safety Different medications show different benefits for children with kidney inflammation
This network meta-analysis evaluates immunosuppressive regimens for Chinese children with Henoch-Schönlein purpura nephritis. The analysis i…
New data helps doctors choose the best medication combinations to treat kidney inflammation in children with IgA vasculitis.
Frontiers Aug 3, 2026
Late-onset BK polyomavirus nephropathy can occur years after kidney transplant without intensified immunosuppression
Urology Sys. Review
Late-onset BK polyomavirus nephropathy can occur years after kidney transplant without intensified immunosuppression Late BK Virus Can Harm Kidney Transplants Years Later
This case report describes 2 kidney transplant recipients who developed late-onset BK polyomavirus-associated nephropathy (BKPyVAN) 9 and 3 …
Two kidney recipients developed BK virus kidney damage years after transplant, even without strong immune suppression.
Frontiers Jul 7, 2026
Steroid avoidance may reduce death and diabetes after kidney transplant but raises rejection risk
Cardiology Sys. Review
Steroid avoidance may reduce death and diabetes after kidney transplant but raises rejection risk Steroid avoidance after kidney transplant may reduce death and diabetes
This systematic review of 53 studies (8317 participants) found that steroid avoidance may reduce all-cause death at 1-5 years and post-trans…
Skipping steroids after a kidney transplant might lower the risk of death and diabetes, but could raise the chance of rejection.
Cochrane Jun 2, 2026
Guideline narrative review discusses diabetes risks from immunosuppressive therapy in kidney transplant recipients
Nephrology Guideline
Guideline narrative review discusses diabetes risks from immunosuppressive therapy in kidney transplant recipients Guidelines address diabetes risks in kidney transplant patients
This publication is a narrative review guideline addressing Post-transplant diabetes mellitus and Type 2 Diabetes.
New guidance outlines considerations for kidney transplant patients dealing with diabetes and medication risks associated with therapy.
Frontiers Apr 29, 2026
Itacitinib plus standard therapy in acute leukemia or myelofibrosis patients undergoing reduced-intensity conditioning donor stem cell transplantation
Oncology Phase II
Itacitinib plus standard therapy in acute leukemia or myelofibrosis patients undergoing reduced-intensity conditioning donor stem cell transplantation Early trial explores itacitinib for stem cell transplant patients with blood disorders
This Phase IIa trial evaluated itacitinib combined with tacrolimus and sirolimus in patients with acute leukemia, myelodysplastic syndrome, …
A new trial adds itacitinib to standard care for stem cell transplant patients with blood disorders to help prevent graft-versus-host diseas…
CT.gov Apr 13, 2026
CFZ533 vs Tacrolimus in Kidney Transplant: Phase 2 Study Terminated After Interim Analysis
Nephrology Phase II
CFZ533 vs Tacrolimus in Kidney Transplant: Phase 2 Study Terminated After Interim Analysis Did a new drug for kidney transplant patients work better than standard treatment?
A Phase 2 study comparing the anti-CD40 monoclonal antibody CFZ533 to tacrolimus for preventing organ rejection in kidney transplant recipie…
A planned five-year kidney transplant drug trial ended early after an interim look, leaving the key question about the new treatment's perfo…
CT.gov Mar 30, 2026