Clinical trials: Immunosuppressive Treatment
Heart Transplantation, Liver Transplantation
Study to Ascertain if Prolonged Release Tacrolimus (FK506E - MR4) is Safe and Effective When Used in the Long Term and in Combination With Other Immunosuppressive Drugs in Patients Who Have Received a Transplant
The purpose of this study was to offer patients who had participated in one of the phase II PK or phase III studies on FK506E (MR4) the possibility to continue FK506E (MR4) until commercial availability of the drug and to record…
- Conditions
- Heart Transplantation, Liver Transplantation, Kidney Transplantation
- Trial name
- NCT02118896
- Testing
- FK506E
- Where
- 105 sites in United States, Australia and 21 more
- Volunteers
- 850 people
- Sponsor
- Astellas Pharma Europe Ltd.
Crohn's Disease
Prochymal™ Adult Human Mesenchymal Stem Cells for Treatment of Moderate-to-severe Crohn's Disease
Human mesenchymal stem cells (MSCs), derived from healthy adult volunteer human donors, can be obtained from bone marrow donation and cultured in the laboratory.
- Trial name
- NCT00294112
- Testing
- Prochymal™ adult human mesenchymal stem cells, adult human mesenchymal stem cells
- Where
- 4 sites in United States
- Volunteers
- 10 people
- Sponsor
- Mesoblast, Inc.
Systemic Lupus Erythematosus
Retrospective Medical Chart Review Study to Describe the Experience of SLE Patients Treated With Anifrolumab in the Early Access Programs.
The ERYTHRO study is a retrospective medical chart review study of patients in the AMANA and ATUc Early Access Programs (EAPs) across a number of countries, to assess anifrolumab usage and patient experience in treating SLE in a…
- Trial name
- ERYTHRO (NCT06046534)
- Testing
- None (Observational study)
- Where
- 15 sites in France, Greece and 5 more
- Volunteers
- 46 people
- Sponsor
- AstraZeneca
Relapsed Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia
Study of a Triple Combination Therapy, DTRM-555, in Patients With R/R CLL or R/R Non-Hodgkin's Lymphomas
Targeted drug therapies have greatly improved outcomes for patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphoma.
- Conditions
- Relapsed Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia, Diffuse Large B Cell Lymphoma, Follicular Lymphoma
- Trial name
- NCT04305444
- Testing
- DTRM-555
- Where
- 8 sites in United States
- Volunteers
- 55 people
- Sponsor
- Zhejiang DTRM Biopharma
Solid Organ Transplant Rejection, Organ Rejection Transplants
Expanded Access for Use of ExoFlo in Abdominal Solid Organ Transplant Patients
This Expanded Access Protocol will provide access to the IMP ExoFlo for patients who have severe or life-threatening abdominal solid organ transplant rejection or who are evaluated and determined to be at high risk of progression…
- Conditions
- Solid Organ Transplant Rejection, Organ Rejection Transplants, Organ Rejection
- Trial name
- NCT05215288
- Testing
- ExoFlo
- Where
- 2 sites in United States
- Sponsor
- Direct Biologics, LLC
Aplastic Anemia
Eltrombopag in Combination With Rabbit Anti-thymocyte Globulin/Cyclosporine A in Naive Aplastic Anemia (AA) Subjects
This was an open label, non-randomized, phase II study of eltrombopag in combination with rabbit ATG/CsA in subjects with moderate or more severe AA who did not received prior ATG/ALG-based immunosuppressive therapy.
- Trial name
- NCT02404025
- Testing
- Eltrombopag, Rabbit ATG, CsA
- Where
- 11 sites in Japan
- Volunteers
- 10 people
- Sponsor
- Novartis Pharmaceuticals
Ulcerative Colitis, Active Moderate
Adacolumn in Refractory UC Patients Trial
The objectives of the study are to observe and document the efficacy and safety of 5 or more Adacolumn treatments, administered once weekly over 5 or more weeks, in a specific subset of ulcerative colitis patients.
- Trial name
- ART (NCT01481142)
- Testing
- (GMA) Adsorptive Apheresis
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Otsuka Pharmaceutical Europe Ltd
Liver Transplantation
REnal Function in Liver Transplantation: Everolimus With Calcineurin Inhibitor (CNI)-Sparing sTrategy
The purpose of this study was, starting from the Italian clinical practice in liver transplantation, to optimize the immunosuppressive therapy, considering specific patient characteristics as alcoholic cirrhosis, hepatitis C…
- Trial name
- REFLECT (NCT02115113)
- Testing
- Everolimus, Tacrolimus
- Where
- 14 sites in Italy
- Volunteers
- 78 people
- Sponsor
- Novartis Pharmaceuticals
Severe Aplastic Anemia (SAA)
Efficacy of Romiplostim in Treatment of SAA in Adults Previously Untreated With or Refractory to Immunosuppressive Therapy
Romiplostim has been used in clinical trials for the treatment of severe and very severe aplastic anemia (SAA/vSAA) in Asian participants who are either previously untreated with immunosuppressive therapy (IST) or refractory to…
- Trial name
- NCT05323617
- Testing
- Romiplostim, Antithymocyte Globulin, Cyclosporine A
- Sponsor
- Amgen
BK Polyomavirus, Kidney Diseases
Study of FK778 in Renal Transplant Recipients With Untreated BK Nephropathy
The purpose of this study is to assess the safety and effectiveness of a new oral immunosuppressant agent compared to standard care in renal transplant patients diagnosed with BK nephropathy.
- Trial name
- NCT00104338
- Testing
- FK778
- Where
- 21 sites in United States
- Volunteers
- 45 people
- Sponsor
- Astellas Pharma Inc
Myasthenia Gravis
A Study to Compare the Efficacy and Safety of Tacrolimus Capsules in Patient With Myasthenia Gravis
To evaluate the efficacy and safety of tacrolimus capsules in patients with myasthenia gravis who are inadequately treated by glucocorticoid.
- Trial name
- NCT01325571
- Testing
- Tacrolimus capsule
- Where
- 9 sites in China
- Volunteers
- 83 people
- Sponsor
- Astellas Pharma Inc
Adult Patients With Chronic Primary ITP, Adult Patients With SAA Who do Not Respond Well to Immunosuppressive Therapy
Study of the Food Effects of Herombopag Olamine Tablets in Healthy Subjects.
This study was designed as a single-center, randomized, open, two-cycle, cross-over trial. It is planned to enroll 18 healthy subjects
- Trial name
- NCT06346925
- Testing
- Herombopag Olamine Tablets
- Where
- China
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Clostridium Difficile
A Post-marketing, Blinded Study to Investigate How Effective Fidaxomicin is Compared to Vancomycin in the Sustained Cure of Clostridium Difficile Infection in Adults That Are Receiving Therapy to Suppress the Immune System
The primary objective is to compare fidaxomicin versus vancomycin for the sustained clinical cure of Clostridium difficile Infection (CDI) in adult patients receiving immunosuppressive therapy.
- Trial name
- FREEDOM (NCT01775397)
- Testing
- Fidaxomicin, Vancomycin
- Where
- 16 sites in Austria, Denmark and 5 more
- Volunteers
- 12 people
- Sponsor
- Astellas Pharma Europe Ltd.
Kidney Transplantation
An Observational Study on Renal Function in Kidney Transplant Participants on Immunosuppressive Therapy Containing Mycophenolate Mofetil
This observational study will evaluate renal function in participants who underwent renal allograft transplantation and are started on combined immunosuppressive treatment containing mycophenolate mofetil (CellCept).
- Trial name
- ORANGE (NCT01672957)
- Testing
- Mycophenolate Mofetil, Immunosuppressive Therapy
- Where
- 2 sites in Hungary
- Volunteers
- 128 people
- Sponsor
- Hoffmann-La Roche
Leukemia, Leukemia, Myeloid
Natural Killer Cell (CYNK-001) Infusions in Adults with AML
This study will find the maximum tolerated dose or the maximum planned dose of CYNK-001 which contains natural killer (NK) cells derived from human placental CD34+ cells and culture-expanded.
- Conditions
- Leukemia, Leukemia, Myeloid, Leukemia, Myeloid, Acute, Neoplasms by Histologic Type
- Trial name
- CYNK001AML01 (NCT04310592)
- Testing
- CYNK-001
- Where
- 10 sites in United States
- Volunteers
- 27 people
- Sponsor
- Celularity Incorporated
Adult Patients With Chronic Primary ITP, Adult Patients With SAA Who do Not Respond Well to Immunosuppressive Therapy
Study of the Food Effects of Herombopag Olamine Tablets in Healthy Subjects
This study used a single-center, randomized, open-label, three-period, crossover trial design. Fifteen healthy subjects were planned to be enrolled, and the subjects were randomly assigned to any group A, B and C in the order of…
- Trial name
- NCT06062680
- Testing
- Herombopag Olamine Tablets
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Kidney Transplantation
A Safety and Efficacy Study of FCR001 Cell Therapy in Previously Transplanted Living Donor Kidney Recipients
An open-label study to assess the safety, tolerability, and efficacy of FCR001 cell therapy in adult recipients 3-12 months after kidney transplantation from a living donor.
- Trial name
- FREEDOM-2 (NCT01649388)
- Testing
- FCR001
- Where
- 3 sites in United States
- Sponsor
- Talaris Therapeutics Inc.
Asthma, Bronchial, Bronchial Asthma
Dose Response of Inhaled Tacrolimus in Patients With Moderate Persistent Asthma
This study will evaluate the efficacy and safety of tacrolimus in patients with asthma.
- Trial name
- NCT00189787
- Testing
- tacrolimus
- Where
- 49 sites in Bulgaria, Czechia and 5 more
- Volunteers
- 370 people
- Sponsor
- Astellas Pharma Inc
Kidney Transplantation
Study of Immunosuppressive Therapy Toxicities in Kidney Transplant Recipients at Regional or Satellite Community Clinics
This is a multicentre, observational, non-interventional, retrospective analysis by chart review.
- Trial name
- NCT00902980
- Testing
- Chart Review
- Where
- 13 sites in Canada
- Volunteers
- 264 people
- Sponsor
- Astellas Pharma Inc
Renal Transplantation
Efficacy and Safety of Everolimus With Enteric-Coated Mycophenolate Sodium (EC-MPS) in a Cyclosporine Microemulsion-free Regimen Compared to Standard Therapy in de Novo Renal Transplant Patients
The purpose of this study is to assess whether a calcineurin inhibitor (CNI)-free regimen with enteric-coated mycophenolate sodium (EC-MPS) and everolimus is as safe and well-tolerated as the standard regimen containing…
- Trial name
- NCT00154310
- Testing
- Everolimus, Cyclosporine, Enteric-coated mycophenolate sodium
- Where
- 3 sites in Germany, Switzerland
- Volunteers
- 300 people
- Sponsor
- Novartis