Clinical trials: Decreased Immunologic Activity
Kidney Transplantation
Safety and Efficacy of FTY720 in Adult Patients Who Receive a Kidney Transplant
The efficacy and safety of FTY720 is being evaluated in patients who receive a kidney transplant.
- Trial name
- NCT00099749
- Testing
- FTY 720
- Where
- 5 sites in United States
- Volunteers
- 255 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplantation
Efficacy and Tolerability of Full Dose Enteric-coated Mycophenolate Sodium, in Addition to Cyclosporine for Microemulsion Reduced Dose, in Maintenance Renal Transplant Recipients
The study will evaluate kidney graft function in maintenance renal transplant patients.
- Trial name
- NCT00434590
- Testing
- Enteric coated mycophenolate sodium (Myfortic®)
- Where
- Italy
- Volunteers
- 10 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplant Rejection
CLinical Utility of the omnigrAf® biomarkeR Panel In The Care of kidneY Transplant Recipients
This is a prospective, multi-site, observational study with a matched control group. The primary objective is to evaluate change in renal function over time in recipients of kidney transplants who are undergoing OmniGrafTM…
- Trial name
- CLARITY (NCT05482100)
- Testing
- Patients monitored with OmniGraf testing
- Volunteers
- 500 people
- Sponsor
- Transplant Genomics, Inc.
Liver Transplant Rejection
TRU-IMMUNO: Optimizing Liver Immunosuppression
This is a prospective, multi-center, randomized study. The primary objective is to evaluate the feasibility and utility of TruGraf/TRAC Liver testing used in addition to standard of care measures of liver dysfunction to guide…
- Trial name
- NCT05335551
- Testing
- Patients monitored with TruGraf and TRAC Liver testing
- Volunteers
- 130 people
- Sponsor
- Transplant Genomics, Inc.
Kidney Transplantation
Comparison of Standard Versus Low Dose Advagraf® With or Without Angiotensin-converting Enzyme Inhibitor (ACEi)/Angiotensin Receptor Blocker (ARB) on Histology and Function of Renal Allografts
This is a multicentre study examining the use of Advagraf-minimization strategy and/or the use of an inhibitor of the renin-angiotensin system in reducing chronic rejection in renal allografts.
- Trial name
- NCT00933231
- Testing
- tacrolimus, Simulect, Cellcept
- Where
- 13 sites in Canada
- Volunteers
- 281 people
- Sponsor
- Astellas Pharma Inc
Kidney Transplantation
A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Kidney Transplant Patients
A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable kidney transplant patients converted from a Prograf® based immunosuppression regimen to a modified release tacrolimus based…
- Trial name
- NCT00282568
- Testing
- Tacrolimus Modified Release (MR), tacrolimus
- Where
- 9 sites in United States, Canada
- Volunteers
- 70 people
- Sponsor
- Astellas Pharma Inc
Kidney Transplantation
Efficacy and Safety of AEB071 Versus Tacrolimus in Combination With Mycophenolate Acid Sodium, Basiliximab and Steroids in Preventing Acute Rejection After Kidney Transplantation
Efficacy and safety of AEB071 in combination with mycophenolate acid sodium, basiliximab and steroids in preventing acute rejection after kidney transplantation.
- Trial name
- NCT00492869
- Testing
- AEB071
- Where
- 41 sites in United States, Belgium and 5 more
- Volunteers
- 124 people
- Sponsor
- Novartis Pharmaceuticals
Asthma, Wheezing
A Post Marketing Evaluation of the Effectiveness of FluMist Risk Minimization Plan in Children
This is a retrospective cohort study of children included in a large medical insurance claims database.
- Conditions
- Asthma, Wheezing, Immunosuppression
- Trial name
- NCT00626808
- Testing
- No Intervention
- Where
- United States
- Volunteers
- 321,697 people
- Sponsor
- MedImmune LLC
de Novo Kidney Transplant Recipients, Renal Transplantation
Once-a-day Regimen With Everolimus, Low Dose Cyclosporine and Steroids in Comparison With Steroid Withdrawal or Twice a Day Regimen With Everolimus, Low Dose Cyclosporine and Steroids.
This study will compare the following immunosuppressive regimens in recipients of kidney transplantation: A) everolimus, cyclosporine and steroids given once-a-day; B) everolimus and cyclosporine given twice a day with steroid…
- Trial name
- EVIDENCE (NCT01023815)
- Testing
- everolimus, cyclosporine, Prednison (continuous steroids)
- Where
- 28 sites in Italy
- Volunteers
- 330 people
- Sponsor
- Novartis
Age-related Muscle Decline
CALM-AF-AI: Counteracting Age-related Loss of Muscle With AAV-Follistatin Combined With Angiogenesis-Inducing VEGF Plasmid Gene Therapy
This Phase 1/2a, open-label, non-randomized study is designed to evaluate the safety and tolerability of intramuscular AAV9-Follistatin gene therapy administered either as monotherapy or in combination with a VEGF-encoding…
- Trial name
- CALM-AF-AI (NCT07443826)
- Testing
- AAV9-Follistatin gene therapy, VEGF Plasmid
- Where
- Honduras
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Unlimited Biotechnology LLC
Kidney Transplantation
Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients
This study was to compare CFZ533 to tacrolimus (TAC) in prevention of organ rejection in kidney transplant.
- Trial name
- CIRRUS I (NCT03663335)
- Testing
- CFZ533 - Cohort 1/Cohort 2, Mycophenolate Mofetil (MMF), Corticosteroids (CS)
- Where
- 74 sites in United States, Argentina and 18 more
- Volunteers
- 418 people
- Sponsor
- Novartis Pharmaceuticals
Bone Marrow Transplantation, Graft Versus Host Disease
A Study to Assess Efficacy, Safety and Pharmacokinetics of a Tacrolimus New Oral Formulation (MR4) in BMT Recipients
A study to assess efficacy, safety and pharmacokinetics of a tacrolimus new oral formulation (MR4) in de novo bone marrow transplant recipients
- Conditions
- Bone Marrow Transplantation, Graft Versus Host Disease, Graft-Vs-Host Disease, Graft-Versus-Host Disease
- Trial name
- NCT00189761
- Testing
- Tacrolimus
- Where
- 4 sites in Japan
- Sponsor
- Astellas Pharma Inc
Kidney Transplantation
Comparing Efficacy & Safety of Tacrolimus & MMF With/Without Induction in the Elderly Following Kidney Transplantation.
Primary objective of this study is to compare the renal function as well as the incidence of renal dysfunction, the incidence of death, graft loss and acute rejection.
- Trial name
- SENIOR (NCT00296309)
- Testing
- Tacrolimus
- Where
- 33 sites in Belgium, France and 5 more
- Volunteers
- 267 people
- Sponsor
- Astellas Pharma Inc
Renal Transplantation
Safety and Efficacy Study of Voclosporin and Tacrolimus in Transplantation
The purpose of this study is to demonstrate the efficacy and safety of voclosporin administered orally twice daily for the prevention of acute allograft rejection in recipients of a kidney transplant.
- Trial name
- INSPIRE (NCT01586845)
- Testing
- voclosporin, tacrolimus
- Sponsor
- Aurinia Pharmaceuticals Inc.
Kidney Transplantation
A Study Looking at Diabetes in Kidney Transplant Recipients Receiving Immunosuppressive Regimen With or Without Steroids
The purpose of this study is to focus on potential differences in the occurrence of new-onset Diabetes Mellitus (a glucose metabolism disorder) when two different regimens of immunosuppressive treatment are compared.
- Trial name
- ADVANCE (NCT01304836)
- Testing
- Advagraf, Mycophenolate Mofetil, Simulect
- Where
- 100 sites in Australia, Belgium and 22 more
- Volunteers
- 1,166 people
- Sponsor
- Astellas Pharma Inc
Transplantation Infection
Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients
The purpose of this study was to allow the continuation of everolimus treatment in patients who have completed the core study (NCT00170885) and to collect long-term safety, tolerability, and efficacy data in a group of patients…
- Trial name
- EVEREST (NCT01276457)
- Testing
- Everolimus 0.25 and 0.75 mg tablets, Cyclosporine very low dose (150-300 ng/mL) microemulsion, Cyclosporine low dose (350-500 ng/mL) microemulsion
- Volunteers
- 223 people
- Sponsor
- Novartis Pharmaceuticals
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.
Heart Transplant, Immunosuppression
HeartCare Immuno-optimization in Cardiac Allografts (MOSAIC)
This is an unblinded, randomized, controlled, two-arm interventional research study enrolling patients who are undergoing heart transplantation.
- Conditions
- Heart Transplant, Immunosuppression, Allograft
- Trial name
- MOSAIC (NCT05459181)
- Testing
- HeartCare
- Volunteers
- 930 people
- Sponsor
- CareDx
Kidney Transplant
Non-inferiority Study of Safety and Efficacy of Everolimus With Low Dose Tacrolimus to Mycophenolate Mofetil With Standard Dose Tacrolimus in Kidney Transplant Recipients
The purpose of this phase 3b study is to compare the safety and efficacy of everolimus with low dose tacrolimus to mycophenolate mofetil with standard dose tacrolimus in kidney transplant recipients.
- Trial name
- NCT01025817
- Testing
- Everolimus and tacrolimus, mycophenolate mofetil and tacrolimus
- Where
- 50 sites in United States, Canada
- Volunteers
- 613 people
- Sponsor
- Novartis Pharmaceuticals
Liver Failure
Assessment of the Pharmacokinetic Profile of Tacrolimus Medications and Their Relation to Effectiveness and Safety in Liver Transplant Patients
The goal of this observational study is oo compare the pharmacokinetic parameters of different tacrolimus containing medications in liver transplant patients.
- Trial name
- LTA (NCT05744635)
- Testing
- Tacrolimus
- Where
- 2 sites in Hungary, Slovenia
- Volunteers
- 110 people
- Sponsor
- Chiesi Hungary Ltd.