Clinical trials: Immunosuppression
Immunosuppression, Renal Failure
Conversion to Everolimus From Calcineurin Inhibitor With Mycophenolic Acid: Impact on Long Term Renal Function in Liver Transplantation.
This study will examine the renal sparing impact of implementing a strategy of conversion to everolimus from a calcineurin inhibitor based immunosuppressive protocol at 3 months post liver transplant
- Trial name
- NCT01936519
- Testing
- Arm A: Everolimus, Calcineurin Inhibitor
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Milton S. Hershey Medical Center
Diabetes Mellitus, Type 1
New Onset of Type 1 Diabetes Mycophenolate Mofetil-Daclizumab Clinical Trial
The objective of this study is to identify immune intervention strategies that will preserve residual beta cell function at the onset of type 1 diabetes.
- Trial name
- TN02 (NCT00100178)
- Testing
- Mycophenolate mofeteil (MMF), Daclizumab (DZB)
- Where
- 11 sites in United States, Canada
- Volunteers
- 126 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Living Donor Liver Transplantation
DCreg in Living Donor Liver Transplantation
Phase I/II, single center, prospective, open-label, non-controlled, non-randomized, interventional, cohort study in which low risk living donor liver transplant (LDLT) recipients will receive a single infusion of donor-derived…
- Trial name
- NCT03164265
- Testing
- Regulatory Donor-Derived Dendritic Cell infusion
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Angus W. Thomson PhD DSc
Atherosclerosis, Kidney Failure
Study Comparing Effect On Carotid Atherosclerosis Following Conversion From Tacrolimus To Sirolimus Post-Transplant In Kidney Transplant Patients
The purpose of this study is to determine whether immunosuppression by tacrolimus, mycophenolate mofetil, and prednisone compared to conversion to sirolimus, mycophenolate mofetil, and prednisone affect the progression of…
- Trial name
- NCT00311311
- Testing
- tacrolimus, mycophenolate mofetil, prednisone
- Where
- 8 sites in United States, Canada
- Volunteers
- 72 people
- Sponsor
- Pfizer
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
Immunosuppression in Solid Organ Transplant
Belatacept in Liver Transplant Recipients
The purpose of this clinical research study is to evaluate the effects of belatacept, relative to tacrolimus, on the incidence of rejection, graft loss and death in subjects receiving a liver transplant
- Trial name
- NCT00555321
- Testing
- Tacrolimus, Basiliximab, Belatacept More Intensive (MI)
- Where
- 42 sites in United States, Argentina and 7 more
- Volunteers
- 260 people
- Sponsor
- Bristol-Myers Squibb
Liver Cirrhosis, Liver Transplant Disorder
Steroid Free Immunosuppression in Liver Transplantation
The purpose of this study is to determine whether steroid-related complications can be avoided by using steroid-free immuno-suppressive drug regimen after liver transplantation.
- Trial name
- NCT00296244
- Testing
- Steroids, Basiliximab, Tacrolimus
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Thomas Jefferson University
Liver Transplant Recipient, Living Donor (of the Respective Liver Transplant Recipient)
Donor Alloantigen Reactive Tregs (darTregs) for Calcineurin Inhibitor (CNI) Reduction
This research study is for liver transplant recipients and their respective living donors. The purpose of this study is: 1. To see if it is safe for liver recipients to receive one dose of donor reactive T regulatory cells…
- Trial name
- ARTEMIS (NCT02474199)
- Testing
- darTregs, Acetaminophen, Diphenhydramine
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Renal Transplant Rejection, Immunosuppression
Cytokines Evaluation in Early Calcineurin Inhibitors Withdrawn on Renal Transplant
Currently, acute kidney injury is diagnosed by increased serum creatinine. However, creatinine is not a reliable marker for acute changes in renal function.
- Trial name
- NCT01239472
- Testing
- Everolimus
- Where
- Brazil
- Volunteers
- 30 people
- Sponsor
- Andre Barreto Pereira
Liver Transplant, Liver Transplantation
Evaluation of Donor Specific Immune Senescence and Exhaustion as Biomarkers of Tolerance Post Liver Transplantation
The primary aim of this study is to determine whether a peripheral blood or graft lymphocyte phenotype of immune senescence or exhaustion is different between operationally tolerant and non-tolerant liver allograft recipients.
- Trial name
- OPTIMAL (NCT02533180)
- Testing
- Immunosuppression withdrawal
- Where
- 7 sites in United States
- Volunteers
- 100 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Myositis Associated Interstitial Lund Disease (MA-ILD)
Myositis Interstitial Lung Disease Nintedanib Trial
This research study will evaluate safety and how well the study drug, nintedanib improve symptoms in participants with myositis associated interstitial lung disease (MA-ILD).
- Trial name
- MINT (NCT05799755)
- Testing
- Nintedanib, Standard of Care
- Where
- 10 sites in United States
- Volunteers
- 62 people
- Sponsor
- Rohit Aggarwal, MD
Kidney Transplant Failure and Rejection
Comparison of the Cognitive and Motor Effects of Treatment Between an Immediate- and Extended-release Tacrolimus (Envarsus® XR) Based Immunosuppression Regimen in Kidney Transplant Recipients
The primary objective is to compare the effect of treatment with an immediate-release tacrolimus to an extended-release tacrolimus (i.e., Envarsus® XR) immunosuppressive regimen on cognitive and motor function in kidney…
- Trial name
- NCT03437577
- Testing
- immediate-release tacrolimus, extended release tacrolimus
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- University of Minnesota
Liver Transplantation
Biomarkers Predicting Successful Tacrolimus Withdrawal and Everolimus (Zortress) Monotherapy Early After Liver Transplantation
Most patients who get a liver transplant must take immunosuppressants for the rest of their lives. However, this has occurred at the expense of chronic CNI toxicity, e.g.
- Trial name
- NCT02736227
- Testing
- Tacrolimus Withdrawal and Everolimus Monotherapy
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Northwestern University
Kidney Transplantation
Regimen Optimization Study
Patients who undergo a kidney transplant require prolonged therapy with drugs that suppress the immune system (called immunosuppressive regimens) to stop the immune system from attacking the transplanted kidney in order to limit…
- Trial name
- NCT02137239
- Testing
- Thymoglobulin, Belatacept, mycophenolate mofetil(MMF)
- Where
- 20 sites in United States, Argentina
- Volunteers
- 58 people
- Sponsor
- Bristol-Myers Squibb
Kidney Transplantation
To Compare the Effects of Immediate-release Tacrolimus and Astagraf XL on Donor-Specific Antibody (DSA) Formation and the Development of Immune Activation (IA) in de Novo Kidney Transplant Recipients
This study compared the incidence of a two-part composite endpoint consisting of de novo donor specific antibody (DSA) formation or a designation of immune activation (IA) on peripheral blood molecular profiling in participants…
- Trial name
- ASTOUND (NCT02723591)
- Testing
- Tacrolimus, Tacrolimus immediate release
- Where
- 30 sites in United States
- Volunteers
- 599 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Sepsis
Kidney Response to Sepsis Affects Angiogenic Balance and Likelihood of CCI and PICS
This study investigates the mechanism by which kidney dysfunction perpetuates inflammation, immunosuppression, and catabolism (PICS) in chronic critical illness.
- Trial name
- NCT02276066
- Testing
- GFR by Iohexol, Urine Collection, Blood samples
- Where
- United States
- Volunteers
- 73 people
- Sponsor
- University of Florida
Sepsis
Project 4A: Inspiratory Muscle Training and Diaphragm Strength
Investigators will assess the effect of exercise on markers of inflammation and protein catabolism. This research study will further our understanding of how treating Chronic Critical illness (CCI) - related respiratory muscle…
- Trial name
- NCT02367170
- Testing
- Bilateral phrenic nerve stimulation and measurement of transdiaphragmatic pressure, Midazolam, Volitional Measurement of Maximal Inspiratory Pressure (MIP)
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- University of Florida
Kidney Transplantation
Study of a JAK3 Inhibitor for the Prevention of Acute Rejection in Kidney Transplant Patients
A new immunosuppressive drug, based on the inhibition of an important enzyme in the immune system called JAK3, is being developed by Pfizer to prevent transplant rejection.
- Trial name
- NCT00483756
- Testing
- Cyclosporine, CP-690,550
- Where
- 69 sites in United States, Australia and 13 more
- Volunteers
- 338 people
- Sponsor
- Pfizer
Kidney Transplantation, Chronic Kidney Failure
Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression (BENEFIT)
The purpose of this study is to learn if Belatacept can provide protection from organ rejection following kidney transplantation while avoiding some of the toxic effects of standard immunosuppressive medications such as kidney…
- Trial name
- BENEFIT (NCT00256750)
- Testing
- Cyclosporine (CsA), Belatacept LI (less intensive), Belatacept MI (more intensive)
- Where
- 105 sites in United States, Argentina and 19 more
- Volunteers
- 738 people
- Sponsor
- Bristol-Myers Squibb
Kidney Transplantation
Combination Drug Therapy Followed by Single Drug Steroid Free Therapy to Prevent Organ Rejection in Kidney Transplantation
This study will test the safety and effectiveness of a combination of three drugs followed by long-term treatment with just one drug in preventing organ rejection in kidney transplant patients.
- Trial name
- NCT00076570
- Testing
- Sirolimus, Tacrolimus
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)