Clinical trials: Tacrolimus
Severe Aplastic Anemia, Acquired Amegakaryocytic Thrombocytopenia
MT2023-20: Hematopoietic Cell Transplant With Reduced Intensity Conditioning and Post-transplant Cyclophosphamide for Severe Aplastic Anemia and Other Forms of Acquired Bone Marrow Failure.
A phase II trial of a reduced intensity conditioned (RIC) allogeneic hematopoietic cell transplant (HCT) with post-transplant cyclophosphamide (PTCy) for idiopathic severe aplastic anemia (SAA), paroxysmal nocturnal…
- Conditions
- Severe Aplastic Anemia, Acquired Amegakaryocytic Thrombocytopenia, Acquired Pure Red Cell Aplasia, Paroxysmal Nocturnal Hemoglobinuria
- Trial name
- NCT06412497
- Testing
- Rituximab, Rabbit ATG, Cyclophosphamide
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Masonic Cancer Center, University of Minnesota
Myelodysplastic Syndromes, Hodgkin's Lymphoma
Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation
Background: In allogeneic stem cell transplantation (SCT), stem cells are taken from a donor and given to a recipient. Sometimes the recipient's immune system destroys the donors' cells.
- Conditions
- Myelodysplastic Syndromes, Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma, Acute Leukemia
- Trial name
- NCT02356159
- Testing
- Rituximab, Conditioning chemotherapy, TMS
- Where
- 2 sites in United States
- Volunteers
- 34 people
- Sponsor
- National Cancer Institute (NCI)
Kidney Transplant; Complications
Conversion Pharmacodynamic Study in Stable Renal Transplant Patients Receiving Tacrolimus Two Times a Day to a New Formulation of Tacrolimus - LCP Tacro - 1 Time a Day.
LCP-Tacro is an extended-release formulation of tacrolimus designed for once-daily dosing. Phase 1 studies demonstrated greater bioavailability than twice-daily tacrolimus capsules and no new safety concerns.
- Trial name
- TACPKPD (NCT02961608)
- Testing
- Drug conversion from Tacrolimus (Prograf® or Adoport®) to LCP-Tacrolimus (Envarsus®)
- Where
- Spain
- Volunteers
- 25 people
- Sponsor
- Hospital Universitari de Bellvitge
Acute Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
High Dose Cyclophosphamide, Tacrolimus, and Mycophenolate Mofetil in Preventing Graft Versus Host Disease in Patients With Hematological Malignancies Undergoing Myeloablative or Reduced Intensity Donor Stem Cell Transplant
This pilot phase II trial studies how well high dose cyclophosphamide, tacrolimus, and mycophenolate mofetil work in preventing graft versus host disease in patients with hematological malignancies undergoing myeloablative or…
- Conditions
- Acute Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Diffuse Large B-Cell Lymphoma
- Trial name
- NCT03128359
- Testing
- Busulfan, Cyclophosphamide, Fludarabine Phosphate
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- City of Hope Medical Center
Kidney Transplant; Complications, Drug Interaction Food
Drug Interaction With Envarsus XR and Grapefruit Juice
Transplant patients must take lifelong immunosuppression in order to prevent rejection of their organ. Tacrolimus is the most widely used immnosuppressive agent.
- Trial name
- NCT03916380
- Testing
- Grapefruit Juice
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Shirley M. Tsunoda
Kidney Transplantation
Effect of Different Therapeutic Strategies on Regulatory T Cells in Kidney Transplantation
The objective of the study will be to evaluate the effect of different therapeutic immunosuppressive strategies currently employed in common clinical practice on regulatory T lymphocytes and to verify the hypothesis that the…
- Trial name
- EVERTWIST (NCT01640743)
- Testing
- Tacrolimus + Methylprednisolone, Tacrolimus + Everolimus + Methylprednisolone
- Where
- Italy
- Volunteers
- 58 people
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
End-stage Renal Disease (ESRD), Kidney Transplantation
Microbiota Changes Related to Outcomes in Kidney Transplantation
Chronic kidney disease affects approximately 10% of the world population. End-stage renal disease (ESRD) is associated with immune dysregulation, chronic inflammation, and alteration of the gut and urinary microbiota.
- Trial name
- MICRO-KT (NCT07893691)
- Testing
- Fecal samples, Urinary sample, Blood samples
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Hospices Civils de Lyon
Psoriasis
A Study to Assess the Safety and Effectiveness of Tacrolimus Cream in the Treatment of Psoriasis
A study to assess the safety and effectiveness of tacrolimus cream in the treatment of psoriasis.
- Trial name
- NCT00293891
- Testing
- Tacrolimus Cream
- Where
- 33 sites in United States, Canada
- Volunteers
- 658 people
- Sponsor
- Astellas Pharma Inc
Acute Graft-versus-host Disease
Low-dose Cyclophosphamide or CNI in the Prevention of Acute Graft-versus-host Disease After gDLI
Assess the cumulative incidence of severe (III-IV) aGVHD after low-dose cyclophosphamide or CNI is used to after gDLI. Evaluate the overall survival rate (OS), non recurrent mortality rate (NRM), and recurrence rate (CIR) of two…
- Trial name
- NCT06490562
- Testing
- PDCy, Non Cy
- Volunteers
- 66 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Graft Rejection, Kidney Failure
Study Comparing Two Sirolimus Regimens vs. Tacrolimus and Mycophenolate Mofetil Regimen in Kidney Transplant Recipients
To demonstrate the superiority of SRL + TAC elimination + corticosteroids (Group I) and SRL + MMF + corticosteroids (Group II) to TAC + MMF + corticosteroids (Group III) with respect to renal allograft function at month 12…
- Conditions
- Graft Rejection, Kidney Failure, Kidney Transplant
- Trial name
- NCT00266123
- Testing
- Sirolimus
- Volunteers
- 420 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Hepatocellular Carcinoma
Immunosuppression in Patients Undergoing Liver Transplantation for Hepatocellular Carcinoma
The purpose of this study is to determine the safety and efficacy of sirolimus-based immunosuppressive therapy in patients following orthotopic liver transplantation (OLT) for hepatocellular carcinoma (HCC), with regard to HCC…
- Trial name
- NCT00355862
- Testing
- CNI, MMF, Steroids, Aza etc. (mTOR inhibitor free), Sirolimus
- Where
- Germany
- Volunteers
- 525 people
- Sponsor
- University of Regensburg
Liver Transplantation
Efficacy and Safety of Concentration-controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients
This trial was designed to address important issues that impact recipients of liver allografts as well as clinicians, ie, renal function, reduction or discontinuation of tacrolimus early post-transplantation, and progression rate…
- Trial name
- RAD (NCT00622869)
- Testing
- Tacrolimus (reduced tacrolimus), Tacrolimus (tacrolimus elimination), Tacrolimus (tacrolimus control)
- Where
- 91 sites in United States, Argentina and 17 more
- Volunteers
- 719 people
- Sponsor
- Novartis Pharmaceuticals
Lung Transplant
Envarsus XR in Lung Transplant
Patients undergoing a lung transplant will be enrolled. All patients will undergo lung transplantation with standard post-operative management, including triple immunosuppression.
- Trial name
- NCT04420195
- Testing
- Extended-Release Tacrolimus, Immediate-Release Tacrolimus
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- NYU Langone Health
Kidney Transplantation
Efficacy and Safety of AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months), in Renal Transplant Patients
This study will evaluate the efficacy and safety of AEB071 in preventing acute rejections after kidney transplantation, when combined with tacrolimus for the first 3 months and with myfortic thereafter.
- Trial name
- NCT00403416
- Testing
- AEB071, Mycophenolic Acid
- Where
- 28 sites in United States, Canada and 6 more
- Volunteers
- 215 people
- Sponsor
- Novartis Pharmaceuticals
Chronic GVHD
Chronic Graft-versus-Host Disease Treatment (BMT CTN 0801)
This study is designed as a combined Phase II/III, randomized, open label, multicenter, prospective comparative study of sirolimus plus prednisone versus sirolimus/calcineurin-inhibitor plus prednisone for the treatment of…
- Trial name
- NCT01106833
- Testing
- Sirolimus + calcineurin inhibitor + prednisone, Sirolimus + prednisone
- Where
- 31 sites in United States
- Volunteers
- 151 people
- Sponsor
- Medical College of Wisconsin
AML, ALL
Cord Blood Transplant in Children and Young Adults With Blood Cancers and Non-malignant Disorders
This is a single-arm study to investigate 1-year treatment related mortality (TRM) in patients with life threatening non-malignant and malignant hematologic disorders who do not have a matched related donor for allogeneic…
- Conditions
- AML, ALL, MDS, MPD Withou Myelofibrosis
- Trial name
- NCT04644016
- Testing
- Clofarabine, Fludarabine, Busulfan
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Pediatric Liver Transplantation
Safety and Tolerance of Immunomodulating Therapy With Donor-specific MSC in Pediatric Living-Donor Liver Transplantation
Since the introduction of calcineurin-based immunosuppression, patient and graft survival in pediatric liver transplantation (LT) improved significantly.
- Trial name
- MYSTEP1 (NCT02957552)
- Testing
- Mesenchymal Stem Cells
- Where
- Germany
- Volunteers
- 7 people
- Sponsor
- University Hospital Tuebingen
Renal Transplantation
AADAPT - Analysis of Advagraf Dose Adaptation Post Transplantation
A pharmacokinetics and pharmacogenetics study to complement the current knowledge of tacrolimus prolonged release (Advagraf®) in the immediate post-transplantation period and at steady-state (M3 post transplantation) and to…
- Trial name
- AADAPT (NCT01435291)
- Testing
- Advagraf Capsule, Prograf Capsule
- Where
- 4 sites in France
- Volunteers
- 45 people
- Sponsor
- Centre Hospitalier Universitaire de Nice
Patients With Type 1 Diabetes
Allogeneic Islet Transplantation for the Treatment of Type 1 Diabetes
It is a multicentre, sequential, phase II clinical trial, aiming at evaluating the allogeneic islet transplantation for the treatment of type 1 diabetes.
- Trial name
- GRIIF (NCT01974674)
- Testing
- Allogeneic transplantation of intrahepatic islet
- Where
- France
- Volunteers
- 19 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Lupus Nephritis
A Study to Compare the Efficacy and Safety of Tacrolimus Capsules With Leflunomide Tablets in Lupus Nephritis Patients
The purpose of this study is to compare the efficacy and safety of tacrolimus capsules with leflunomide tablets in the treatment of lupus nephritis.
- Trial name
- NCT01342016
- Testing
- tacrolimus capsule, leflunomide tablet, prednisone
- Where
- 12 sites in China
- Volunteers
- 84 people
- Sponsor
- Astellas Pharma Inc