Clinical trials: Immunosuppression
Phenylketonuria
Immune Modulation During Palynziq® Treatment in Adults (IMPALA)
Study 165-401 is a Phase 4, open-label study designed to examine the concomitant use of methotrexate (MTX) to suppress immune responses to Palynziq and improve tolerability and efficacy in adults with PKU.
- Trial name
- NCT07477691
- Testing
- Pegvaliase, Methotrexate
- Where
- 12 sites in United States
- Volunteers
- 12 people
- Sponsor
- BioMarin Pharmaceutical
Kidney Transplant, Immunosuppression
KidneyCare Immuno-optimization in Renal Allografts (KIRA)
This is an unblinded, randomized, four-arm interventional research study enrolling patients who are undergoing kidney transplantation.
- Conditions
- Kidney Transplant, Immunosuppression, Allograft
- Trial name
- NCT05423496
- Testing
- KidneyCare, steroid, MMF
- Sponsor
- CareDx
Melanoma, Non-small Cell Lung Cancer
A Combination Clinical Study of PLX3397 and Pembrolizumab To Treat Advanced Melanoma and Other Solid Tumors
The goal of this clinical research study is to learn how PLX3397 and pembrolizumab work together to affect cancer cells. PLX3397 is designed to target the receptor for CSF1 (CSF1R).
- Conditions
- Melanoma, Non-small Cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck, Gastrointestinal Stromal Tumor (GIST)
- Trial name
- NCT02452424
- Testing
- PLX3397, Pembrolizumab
- Where
- 12 sites in United States
- Volunteers
- 78 people
- Sponsor
- Daiichi Sankyo
Renal Transplant Rejection
Efficacy and Safety of ATG-Fresenius Following a Renal Transplantation, Without Corticosteroids
The main objective of the study is the assessment of the overall graft rejection rate (acute, chronic and subclinical) between a treatment with ATG-Fresenius administered in addition to standard treatment consisting of CellCept®…
- Trial name
- IBERICA (NCT01324934)
- Testing
- ATG-Fresenius S
- Where
- 10 sites in Portugal, Spain
- Volunteers
- 40 people
- Sponsor
- Neovii Biotech
Renal Transplantation
Study Comparing Efficacy and Safety of Mycophenolate Mofetil (Cellcept) With Delayed Introduction of Sirolimus and Discontinuation of Cyclosporine, With Those of Mycophenolate Mofetil and Long Term Continuation of Cyclosporine in Renal Transplant Recipients
This multicentre, prospective, randomized, open-label study will compare the safety and efficacy of mycophenolate mofetil with delayed introduction of sirolimus and discontinuation of cyclosporine, with those of mycophenolate…
- Trial name
- NCT02686619
- Testing
- Cyclosporine, Daclizumab, Mycophenoate Mofetil
- Where
- 17 sites in France
- Volunteers
- 237 people
- Sponsor
- Hoffmann-La Roche
Renal Transplant
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
The objective of the study is to compare the cardiovascular profile of an everolimus and mycophenolic acid immunosuppressive regimen with a calcineurin inhibitor and mycophenolic acid regimen in maintenance renal transplant…
- Trial name
- EVITA (NCT01169701)
- Testing
- Everolimus, Tacrolimus, Mycophenolic acid (MPA)
- Where
- 9 sites in Spain
- Volunteers
- 71 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplantation
Effect of Rapid Steroid Withdrawal on Subclinical Markers of Rejection
The purpose of this study is to compare the safety and efficacy of a tacrolimus-based 5-day steroid rapid withdrawal immunoprophylactic regimen in de novo renal transplantation.
- Trial name
- NCT00133172
- Testing
- Tacrolimus, mycophenolate mofetil, Prednisone
- Where
- 14 sites in Canada
- Volunteers
- 85 people
- Sponsor
- Astellas Pharma Inc
Transplanted Organ Rejection
A Safety and Efficacy Study of FCR001 vs Standard of Care in de Novo Living Donor Kidney Transplantation
A randomized controlled study to evaluate the safety, efficacy, and overall benefit of FCR001 cell therapy in de novo living donor renal transplantation.
- Trial name
- FREEDOM-1 (NCT03995901)
- Testing
- FCR001
- Where
- 18 sites in United States
- Volunteers
- 15 people
- Sponsor
- Talaris Therapeutics Inc.
Immunosuppression Management, Biomarkers / Blood
PIONEER Trial (Post-Transplant Application of TruGraf and TRAC Molecular Panel in Renal Transplant Recipients)
This is an observational, prospective, multi-center trial designed to evaluate clinical outcomes in kidney transplant recipients undergoing TruGraf and TRAC monitoring. Approximately 15 U.S. sites
- Conditions
- Immunosuppression Management, Biomarkers / Blood, Subclinical Rejection, Biopsy
- Trial name
- PIONEER (NCT07231328)
- Testing
- There is no required Intervention for this Protocol. Based on Results for TruGraf/TRAC/TRAC ID Investigators may use the results in managing subjects Immunosuppression or rule out rejection.
- Volunteers
- 600 people
- Sponsor
- Transplant Genomics, Inc.
Renal Transplantation
A Study of TCD601 in de Novo Renal Transplant Recipients
The purpose of this study is to evaluate the safety and efficacy of TCD601 in combination with Belatacept when compared to standard of care immunosuppression therapy in de novo renal transplant patients.
- Trial name
- ASCEND (NCT05669001)
- Testing
- TCD601, belatacept, ATG
- Where
- 18 sites in United States
- Volunteers
- 76 people
- Sponsor
- ITB-Med LLC
Oxidative Stress, Muscle Strength
The Short Term Effects of Oceanix Supplementation on Recovery
The purpose of this study will be to examine the effects of Oceanix supplementation on isometric mid-thigh pull force kinetics and salivary immunoglobulin A (indice of immune function) following a one-week intense resistance…
- Conditions
- Oxidative Stress, Muscle Strength, Resistance Training, Muscle Damage
- Trial name
- NCT04315077
- Testing
- Oceanix®, Resistance Training
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Applied Science & Performance Institute
Non-infectious Uveitis
Safety and Efficacy of AIN457 in Patients With Quiescent Non-infectious Uveitis
This study will assess the safety and efficacy of AIN457 as adjunctive therapy for the treatment of intermediate uveitis, posterior uveitis, or panuveitis requiring systemic immunosuppression.
- Trial name
- ENDURE (NCT01032915)
- Testing
- AIN457
- Where
- 94 sites in United States, Brazil and 8 more
- Volunteers
- 125 people
- Sponsor
- Novartis Pharmaceuticals
Renal Transplantation
A Study Designed to Compare the Tolerability of an Increased Dose of Enteric-coated Mycophenolate Acid (MPA) in Renal Transplant Patients Whose Dose of Mycophenolate Mofetil (MMF) Was Reduced Due to Gastrointestinal Symptoms
To determine if conversion to enteric coated MPA allows an escalated dose of mycophenolic acid (MPA) to be tolerated in patients experiencing gastrointestinal (GI) symptoms
- Trial name
- NCT00658333
- Testing
- Enteric-coated Mycophenolate Acid (EC-MPA), Mycophenolate Mofetil (MMF)
- Where
- 37 sites in United States
- Volunteers
- 30 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplant Rejection, Immunosuppression
Immunosuppression Management in Renal Transplant Recipients With Transplant Excellence Based on TruGraf Test
This is an investigator-initiated, single-center, prospective, randomized, proof of concept study. In this study patients who are status post kidney transplantation and meet the inclusion and exclusion criteria will undergo…
- Trial name
- NCT04670926
- Testing
- TruGraf, Standard of Care
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Transplant Genomics, Inc.
Liver Transplantation, Kidney Transplantation
A Study to Evaluate the Safety and Efficacy of a Modigraf® Based Immunosuppression Regimen in De Novo Pediatric Allograft Liver and Kidney Transplantation Recipients
The purpose of this study is to observe the safety and efficacy of Modigraf in de novo pediatric allograft liver and kidney transplantation recipients.
- Trial name
- NCT05153915
- Testing
- Tacrolimus granules
- Where
- 7 sites in China
- Volunteers
- 56 people
- Sponsor
- Astellas Pharma China, Inc.
Kidney Transplantation
Benefit of Early Protocol Biopsy and Treatment of Subclinical Rejection
This multicentre randomized, controlled trial (RCT) compared renal allograft histology and function in subjects treated with Tacrolimus + MMF + prednisone undergoing early protocol biopsies and treatment of subclinical rejection…
- Trial name
- NCT00885820
- Testing
- Tacrolimus, MMF, Corticosteroids (Prednisone)
- Where
- 12 sites in United States, Canada
- Volunteers
- 240 people
- Sponsor
- Astellas Pharma Inc
Liver Transplantation
A Study of a Modified-Release Tacrolimus Based Immunosuppression Regimen in Stable Pediatric Liver Transplant Patients
A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable pediatric liver transplant patients converted from a Prograf® based immunosuppression regimen to a modified release tacrolimus based…
- Trial name
- NCT00282256
- Testing
- tacrolimus modified release (MR), tacrolimus
- Where
- 5 sites in United States
- Volunteers
- 19 people
- Sponsor
- Astellas Pharma Inc
Septic Shock
First in Human Trial to Assess the Feasibility and Preliminary Safety of Adjunctive Treatment with the HemoSystem REBOOT in Critically Ill Patients with Sepsis-induced Immunosuppression
The aim of this randomized controlled trial is to restore immune function by selectively removing three mediators largely contributing to sepsis-induced immunosuppression from extracorporeal circulation.
- Trial name
- RESTORE I (NCT06258291)
- Testing
- Hemosystem REBOOT
- Where
- 2 sites in Switzerland
- Volunteers
- 16 people
- Sponsor
- hemotune AG
Uveitis
Safety and Efficacy of AIN457 in Patients With Active Non-infectious Uveitis
This study will assess the safety and efficacy of AIN457 as adjunctive therapy for the treatment of intermediate uveitis, posterior uveitis, or panuveitis requiring systemic immunosuppression.
- Trial name
- INSURE (NCT01095250)
- Testing
- AIN457
- Where
- 36 sites in United States, Canada and 11 more
- Volunteers
- 30 people
- Sponsor
- Novartis Pharmaceuticals
Liver Failure
Pharmacokinetics of LCP-Tacro™ Once Daily and Prograf® Twice A Day in Adult De Novo Liver Transplant Patients
The purpose of this study is to demonstrate the pharmacokinetics (PK, measuring the amount of medication in blood samples) and safety of a new medicine, LCP-Tacro™ tablets, and Prograf® capsules, a drug commonly taken by…
- Trial name
- NCT00772148
- Testing
- LCP -Tacro, Prograf
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- Veloxis Pharmaceuticals