Clinical trials: Immunosuppressive Agents
Kidney Failure, Graft vs Host Disease
A Study Comparing the Withdrawal of Steroids or Tacrolimus in Kidney Transplant Recipients
This study evaluates two different immunosuppression drug regimens in patients with a recent kidney transplant. Patients initially received a regimen of Sirolimus, Tacrolimus and Prednisone and then randomized to discontinue…
- Trial name
- NCT00195429
- Testing
- Tacrolimus, Sirolimus, prednisone
- Where
- Brazil
- Volunteers
- 47 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
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
Renal Transplantation
Extension Study of Enteric-coated Mycophenolate Sodium With Short-term or no Steroid Use Compared With Enteric-coated Mycophenolate Sodium With Standard Steroid Therapy in de Novo Kidney Recipients
The objective of this study is to assess the long-term safety and tolerability of EC-MPS on the patients who completed the core study and wish to continue treatment on EC-MPS.
- Trial name
- NCT00240955
- Testing
- Enteric-coated Mycophenolate sodium (EC-MPS)
- Volunteers
- 79 people
- Sponsor
- Novartis
Aplastic Anemia
Safety and Efficacy of Exjade in the Treatment of Transfusion-dependent Iron Overload in Aplastic Anemia Patients
Evaluated Exjade efficacy and safety in patients with aplastic anemia and transfusion-dependent iron overload, undergoing treatment programs of immunosuppressive treatment (Cyclosporine A) , in comparison with a group of patients…
- Trial name
- NCT01818726
- Testing
- ICL670, Chelation, No chelation
- Where
- Russia
- Volunteers
- 15 people
- Sponsor
- Novartis Pharmaceuticals
Aplastic Anemia
Study of AMG531 (Romiplostim) in Patients With Aplastic Anemia
To evaluate the hematological responses based on the response assessment criteria defined in this study (the 531-004 response assessment criteria) when AMG531 is subcutaneously (SC)-administered with ciclosporin A (CsA) therapy…
- Trial name
- NCT04095936
- Testing
- Romiplostim
- Where
- Japan
- Volunteers
- 24 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Rheumatoid Arthritis, Myositis
Rheumatoid Arthritis and Myositis Cohort
The primary objective of this research is to establish a well characterized clinical and longitudinal cohort for individuals with Rheumatoid Arthritis (RA) and Myositis to create a place to maintain blood, urine, stool specimens…
- Trial name
- NCT05627089
- Sponsor
- Attune Health Research, Inc.
Transplantation
Conversion Study From Cyclosporine to FK506MR Based Immunosuppression in Kidney Transplant Subjects
Assessment of the safety and the efficacy of a tacrolimus modified release (FK506MR) based immunosuppressive regimen in stable kidney transplant subjects converted from a cyclosporin based immunosuppressive regimen.
- Trial name
- CONCERTO (NCT00481481)
- Testing
- tacrolimus
- Where
- 56 sites in Austria, Belgium and 11 more
- Volunteers
- 346 people
- Sponsor
- Astellas Pharma Inc
Diabetic Macular Edema
Suprachoroidal Sustained-Release OXU-001 Compared to Intravitreal Ozurdex® in the Treatment of Diabetic Macular Edema
The purpose of this clinical trial is to compare safety, tolerability, efficacy, and durability of two dose levels of suprachoroidal sustained-release OXU-001 (dexamethasone microspheres; DEXAspheres®) using the Oxulumis®…
- Trial name
- OXEYE (NCT05697809)
- Testing
- OXU-001, Semi-automated suprachoroidal illuminated microcatheter, Ozurdex® Ophthalmic Intravitreal Implant
- Where
- 9 sites in United States, Puerto Rico
- Volunteers
- 3 people
- Sponsor
- Oxular Limited
Healthy
PK, Safety & Tolerability of CyCol® Versus Sandimmune® in Healthy Subjects
The aim of this Phase I, single centre, multi stage study is to evaluate the safety, tolerability, pharmacokinetics and relative colonic mucosal concentrations of cyclosporine capsules (CyCol®) compared to intravenous…
- Trial name
- CYC102 (NCT02130414)
- Testing
- Sandimmun® IV, CyCol® capsules
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Sigmoid Pharma
Liver Transplantation
Pharmacokinetics of Tacrolimus in Liver Transplantation Patients Treated With Prograf and Modified Release Tacrolimus
Tacrolimus pharmacokinetics study in primary living donor liver transplantation patients with Tacrolimus based immunosuppressive regimens.
- Trial name
- NCT00909571
- Testing
- FK506E (modified release tacrolimus), Prograf (tacrolimus)
- Where
- South Korea
- Volunteers
- 10 people
- Sponsor
- Astellas Pharma Inc
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
Lupus Nephritis
Safety and Efficacy on Deoxyspergualin (NKT-01) in Patients With Lupus Nephritis
The aim of the open multi-center study is to determine an efficient and safe dose and dosing schedule of NKT-01 in induction of response in treatment of lupus nephritis.
- Trial name
- NCT00709722
- Testing
- NKT-01
- Where
- 6 sites in Czechia, Germany
- Volunteers
- 21 people
- Sponsor
- Nippon Kayaku Co., Ltd.
Lung Transplantation
Efficacy Regarding Renal Function of Everolimus in Combination With Specific Standard Immunosuppressive Regimen Lung Transplant Recipients
This trial evaluated the efficacy of an everolimus-based quadruple low immunosuppressive regimen versus a standard immunosuppressive regimen concerning kidney function in lung transplant recipients.
- Trial name
- 4EVERLUNG (NCT01404325)
- Testing
- standard therapy, Everolimus
- Where
- 9 sites in Germany
- Volunteers
- 130 people
- Sponsor
- Novartis Pharmaceuticals
Intestine Transplantation, Kidney Transplantation
Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From Prograf® to Advagraf®
Parts A \& B: Conversion of stable pediatric allograft recipients from Prograf® immunosuppression to Advagraf® immunosuppression to compare exposure and one year follow-up for safety and efficacy.
- Conditions
- Intestine Transplantation, Kidney Transplantation, Lung Transplantation, Liver Transplantation
- Trial name
- NCT01294020
- Testing
- Tacrolimus, Tacrolimus prolonged release
- Where
- 16 sites in Belgium, Czechia and 5 more
- Volunteers
- 81 people
- Sponsor
- Astellas Pharma Europe Ltd.
Astrocytoma, Grade IV, Glioblastoma
CYNK-001 IV and IC in Combination With IL2 in Surgical Eligible Recurrent GBM With IDH-1 Wild Type
A Phase 1/2a Open Label Multicenter, Non-Randomized, Trial to Assess the Safety and Efficacy of CYNK-001 in Combination with Recombinant Human Interleukin-2 in Adults with Recurrent Resection Eligible IDH1 wild-type Glioblastoma.
- Conditions
- Astrocytoma, Grade IV, Glioblastoma, Giant Cell Glioblastoma, Glioblastoma Multiforme
- Trial name
- CYNK001GBM02 (NCT05218408)
- Testing
- CYNK-001 systemic and Intra cavity administration
- Sponsor
- Celularity Incorporated
Renal Transplant
A Randomized Study Assess the Safety and Efficacy of Tacrolimus vs Prograf® in Renal Transplantation Treatment
Comparison of safety and efficacy of immunosuppressive regiments using tacrolimus from EMS and Prograf® in post renal transplanted patients.
- Trial name
- NCT01244659
- Testing
- Tacrolimus from EMS, Prograf
- Where
- Brazil
- Sponsor
- EMS
Chronic Idiopathic Thrombocytopenic Purpura, Purpura, Thrombocytopenic, Idiopathic
Clinical Evaluation of SB-497115-GR in Chronic Idiopathic Thrombocytopenic Purpura (ITP)
This is a Phase II/III multicenter study comprising of the double-blind, followed by open-label phases to evaluate and compare the efficacy and tolerability of eltrombopag (SB-497115-GR) in chronic ITP patients
- Trial name
- NCT00540423
- Testing
- SB-497115-GR 12.5mg, SB-497115-GR 25mg, SB-497115-GR 50 mg
- Where
- 7 sites in Japan
- Volunteers
- 23 people
- Sponsor
- GlaxoSmithKline
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
Non-infectious Intermediate Uveitis, Non-infectious Posterior Uveitis
Safety,Tolerability and Efficacy of Intravitreal LFG316 in Patients With Active Non-infectious Intermediate-, posterior-or Panuveitis ,
This was a multi-center, randomized, active-controlled, open-label study. Approximately 24 patients with active, non-infectious intermediate-, posterior-, or panuveitis requiring systemic immunosuppressive therapy were enrolled.
- Conditions
- Non-infectious Intermediate Uveitis, Non-infectious Posterior Uveitis, Non-infectious Panuveitis
- Trial name
- NCT01526889
- Testing
- LFG316, Conventional Therapy
- Where
- 8 sites in United States, United Kingdom
- Volunteers
- 25 people
- Sponsor
- Novartis Pharmaceuticals
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