Clinical trials: Immunosuppressive Treatment
Renal Transplant
Pharmacokinetics of Generic to Brand Tacrolimus in Stable Renal Transplant Patients
The study is designed to compare the pharmacokinetics of generic tacrolimus (Sandoz) to branded tacrolimus (Prograf) in stable renal transplant patients.
- Trial name
- NCT01256294
- Testing
- Generic Tacrolimus, Branded Tacrolimus
- Where
- 2 sites in United States
- Volunteers
- 71 people
- Sponsor
- Novartis
Aplastic Anemia
A Study of Avatrombopag in Adults With Aplastic Anemia Who Did Not Respond to, Cannot Receive, or Had Return of Disease After Standard Treatment
This research study is testing a medicine called avatrombopag in adults with aplastic anemia, a rare condition where the bone marrow does not produce enough blood cells.
- Trial name
- NCT07786922
- Testing
- Avatrombopag 20 mg Oral Tablet
- Volunteers
- 26 people
- Sponsor
- Swedish Orphan Biovitrum
Oestrogen Receptor Positive Advanced Breast Cancer
An Open Label Study of Postmenopausal Women With Oestrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Treated With Everolimus (RAD001) With Exemestane, With Exploratory Epigenetic Marker Analysis
Determine the overall response rate (ORR) at 48 weeks to everolimus (RAD001, 10mg daily p.o.) and exemestane (25mg daily p.o.) treatment in postmenopausal women with oestrogen receptor positive breast cancer who have previous…
- Trial name
- 4EVERUK (NCT01743560)
- Testing
- RAD001, Exemestane
- Where
- 11 sites in United Kingdom
- Volunteers
- 52 people
- Sponsor
- Novartis Pharmaceuticals
Heart Transplantation, Lung Transplantation
Study to Compare the Pharmacokinetics of Tacrolimus in Adult Transplant Recipients Treated With Advagraf® or Prograf®
Comparison of tacrolimus blood levels in adults who have received a transplant and are taking either Prograf or Advagraf anti-rejection therapy immediately following surgery.
- Conditions
- Heart Transplantation, Lung Transplantation, Pancreas (Including SPK) Transplantation
- Trial name
- NCT01332201
- Testing
- Advagraf, Prograf
- Where
- 8 sites in Austria, Belgium and 4 more
- Volunteers
- 17 people
- Sponsor
- Astellas Pharma Inc
Liver Transplantation, Transplantation Immunology
A Randomized Study to Assess the Safety and Efficacy of Prograf vs Prograf-XL in de Novo Liver Transplant Recipients.
The purpose of this study is to compare the efficacy and safety of Prograf extended release(XL) plus MMF with Prograf plus MMF and steroid withdrawal in de novo Liver transplant recipients
- Conditions
- Liver Transplantation, Transplantation Immunology, Host vs Graft Reaction
- Trial name
- NCT00720408
- Testing
- Prograf-XL, Prograf, MMF
- Where
- 4 sites in Taiwan
- Volunteers
- 48 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
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
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
Behcet Disease
Phase III Study in Refractory Behcet's Disease
The purpose of this pivotal trial is to evaluate subcutaneous (SQ) AIN457 as an adjunctive therapy to reduce the rate of exacerbations of posterior uveitis or panuveitis secondary to Behçet's disease during the 24 weeks of study…
- Trial name
- SHIELD (NCT00995709)
- Testing
- AIN457
- Where
- 49 sites in United States, Egypt and 15 more
- Volunteers
- 118 people
- Sponsor
- Novartis Pharmaceuticals
De Novo Kidney Transplant
MYPROMS-ES02: Safety and Efficacy of Basiliximab, Cyclosporine Microemulsion and Enteric-coated Mycophenolate Sodium (EC-MPS) Versus EC-MPS and Steroid Therapy in Kidney Transplant Recipients Who Are Hepatitis C Positive
To prospectively evaluate in de novo kidney transplant recipients, hepatitis C positive, the clinical outcomes of an immunosuppressive regimen of EC-MPS free of steroids in comparison with a regimen of EC-MPS with standard…
- Trial name
- NCT00284921
- Testing
- Enteric-coated Mycophenolate sodium (EC-MPS)
- Volunteers
- 60 people
- Sponsor
- Novartis Pharmaceuticals
Heart Transplantation, Kidney Transplantation
A Study to Compare How the Body Absorbs and Processes Two Different Formulations of the Anti-rejection Medication Tacrolimus (Advagraf® or Prograf®) in Children Receiving an Organ Transplant, and How Safe and Effective They Are Over a Longer Period of Time
The purpose of this study is to compare how the body absorbs and processes two different formulations of the anti-rejection medication tacrolimus (Advagraf® or Prograf®) in children receiving an organ transplant, and how safe and…
- Conditions
- Heart Transplantation, Kidney Transplantation, Liver Transplantation
- Trial name
- NCT01614665
- Testing
- Tacrolimus, Tacrolimus prolonged release
- Where
- 10 sites in Czechia, France and 3 more
- Volunteers
- 44 people
- Sponsor
- Astellas Pharma Europe Ltd.
Thrombotic Thrombocytopenic Purpura
Caplacizumab and Immunosuppressive Therapy Without Firstline Therapeutic Plasma Exchange in Adults With Immune-mediated Thrombotic Thrombocytopenic Purpura
This is a single group, treatment, Phase 3, open-label, single-arm study to evaluate the efficacy and safety of caplacizumab and immunosuppressive therapy (IST) without firstline therapeutic plasma exchange (TPE) with primary…
- Trial name
- MAYARI (NCT05468320)
- Testing
- Caplacizumab, Corticosteroids, anti-CD20 antibody
- Where
- 27 sites in United States, Belgium and 9 more
- Volunteers
- 51 people
- Sponsor
- Sanofi
Astrocytoma, Grade IV, Giant Cell Glioblastoma
Natural Killer Cell (CYNK-001) IV Infusion or IT Administration in Adults With Recurrent GBM
This study will find the maximum safe dose (MSD) or maximum tolerated dose (MTD) of CYNK-001 which are NK cells derived from human placental CD34+ cells and culture-expanded.
- Conditions
- Astrocytoma, Grade IV, Giant Cell Glioblastoma, Glioblastoma Multiforme, Cyclophosphamide
- Trial name
- CYNK001GBM01 (NCT04489420)
- Testing
- CYNK001-IV, CYNK001-IT
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Celularity Incorporated
Liver Transplant
Efficacy and Safety of Cyclosporine Microemulsion Given Once a Day in Adult Stable Liver Transplant Recipients
The purpose of this study is to determine whether cyclosporine microemulsion given once a day instead of twice a day benefits kidney function, blood pressure, lipid profile and glucose control in stable liver transplant…
- Trial name
- NCT00171509
- Testing
- Cyclosporine microemulsion
- Volunteers
- 61 people
- Sponsor
- Novartis
Crohn's Disease
Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease
Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels.
- Trial name
- U-EMPOWER (NCT06332534)
- Testing
- Upadacitinib
- Where
- 85 sites in United States, Australia and 16 more
- Volunteers
- 111 people
- Sponsor
- AbbVie
Aplastic Anemia
A Study of the Safety and Effectiveness of Eltrombopag in Combination With Immunosuppressive Therapy (IST) in Korean Pediatric Patients With Treatment Naïve Severe Aplastic Anemia
The aim of this study was to investigate the safety, tolerability, and effectiveness of eltrombopag in combination with immunosuppressive therapy (IST) in real world practice in pediatric patients with severe aplastic anemia…
- Trial name
- NCT07415083
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplant
A Study to Assess the Efficacy and Safety of Advagraf® Switching From Cyclosporine Between the Group That Was Treated With a 50% Reduced Corticosteroid and the Group With Maintained Corticosteroid for Stable Kidney Transplant Recipients
This study is a multicenter, randomized, comparison, open-label, phase IV study in kidney transplant recipients whose immunosuppressive regimen is converted from Cyclosporine with corticosteroid to Advagraf® with corticosteroid.
- Trial name
- COSMOS (NCT02034747)
- Testing
- Advagraf, Corticosteroid
- Where
- 9 sites in South Korea
- Volunteers
- 150 people
- Sponsor
- Astellas Pharma Korea, Inc.
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.
Uveitis
38 Week Extension Study to CAIN457C2303
A 38-week extension to a 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet's patients with posterior or panuveitis treated with…
- Trial name
- SHIELD (NCT01093846)
- Testing
- AIN457
- Where
- 25 sites in United States, Egypt and 12 more
- Volunteers
- 59 people
- Sponsor
- Novartis Pharmaceuticals