Clinical trials: Kidney Transplant
Kidney Transplantation, Chronic Kidney Failure
Early Conversion From Tacrolimus to Efalizumab Maintenance Therapy in Kidney Transplant Recipients
The toxicity of calcineurin inhibitors(CNI)is a major factor limiting the success of renal transplantation. This protocol aims to replace the calcineurin inhibitor, tacrolimus, with efalizumab early after transplantation in…
- Trial name
- NCT00472082
- Testing
- efalizumab
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Emory University
Renal Transplant Recipients
Research Study of ATG and Rituximab in Renal Transplantation
The purpose of this study is see if a combination of two drugs, (ATG and rituximab), given at the time of the transplant surgery, will help reduce or eliminate the need for long term immunosuppressive medication.
- Trial name
- RESTARRT (NCT01318915)
- Testing
- ATG, Rituximab, Tacrolimus
- Where
- 6 sites in United States
- Volunteers
- 10 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Kidney Transplantation
Evaluation of the Therapeutic Benefit of an Initial Intensified Dosing Regimen of Mycophenolate Sodium Versus a Standard Regimen in Renal Transplant Patients
The purpose of this study is to determine if an initial intensified enteric-coated mycophenolate sodium (Myfortic) dosing regimen administered during the first six weeks post renal transplantation provides improved efficacy, with…
- Trial name
- NCT00419926
- Testing
- Enteric-coated mycophenolate sodium (Myfortic), Cyclosporine (Neoral), Prednisone
- Where
- Switzerland
- Volunteers
- 313 people
- Sponsor
- Novartis
Immunosuppression
Dosing Requirements of Astagraf XL® in African American Kidney Transplant Recipients
Compare the difference in dose-normalized trough and total daily dose necessary to reach the steady state therapeutic goal after conversion from tacrolimus IR to Astagraf XL® in African American kidney transplant recipients.
- Trial name
- NCT02953873
- Testing
- Tacrolimus Extended Release Capsule, Mycophenolate mofetil, Prednisone
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Medical University of South Carolina
Simultaneous Kidney and Pancreas Transplantation
Optimization of NULOJIX® Usage Towards Minimizing CNI Exposure in Simultaneous Pancreas and Kidney Transplantation
The purpose of this study is to find out if the drug NULOJIX® (belatacept) will minimize the amount of other anti-rejection medications necessary and thereby reduce the long-term side effects caused by the other medications.
- Trial name
- NCT01790594
- Testing
- Belatacept, methylprednisolone, Anti-thymocyte Globulin (Rabbit)
- Where
- 5 sites in United States
- Volunteers
- 46 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Actinic Keratosis
Safety and Efficacy of Ingenol Mebutate Gel 0.015% for Treatment of AK on the Face in Solid Organ Transplant Recipients
This is a single arm, open-label interventional study of ingenol mebutate 0.015% in solid organ transplant recipients. The investigators plan to treat 20 subjects, 10 kidney transplant recipients and 10 lung transplant…
- Trial name
- NCT02866695
- Testing
- ingenol mebutate gel 0.015%
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of California, San Francisco
Liver Transplantation
RESCUE Study - Everolimus in Liver Transplantation Recipients With Renal Insufficiency
The purpose of the study is to assess the effect of everolimus initiation together with reduction or discontinuation of calcineurin inhibitor (CNI) on renal function in maintenance liver transplant recipients with CNI-related…
- Trial name
- NCT00267189
- Testing
- Everolimus, Calcineurin inhibitors (CNI), Mycophenolate acid (MPA)/ Azathioprine (AZA)
- Where
- 2 sites in Germany, Switzerland
- Volunteers
- 145 people
- Sponsor
- Novartis Pharmaceuticals
Renal Transplanted Recipients
SOCRATES: Steroid or Cyclosporine Removal After Transplantation Using Everolimus
The aim of this study is to assess the safety and efficacy of corticosteroid discontinuation versus cyclosporine micro emulsion discontinuation in recipients receiving reduced exposure cyclosporine micro emulsion and…
- Trial name
- NCT00371826
- Testing
- Everolimus (RAD001), Cyclosporine (Calcineurin Inhibitor (CNI)), Methylprednisone/prednisone
- Where
- 7 sites in Australia
- Volunteers
- 126 people
- Sponsor
- Novartis Pharmaceuticals
Renal Transplant Rejection, Kidney Transplant Failure and Rejection
Envarsus on the Effect of Total Tacrolimus Dose/Trough Level Ratio on Renal Function (eGFR) in Kidney Transplantation
This is a one year, prospective, randomized, open-label trial examining once versus twice daily tacrolimus dosing regimen using two preparations, extended-release Tacrolimus (Envarsus XR) versus twice daily Tacrolimus (Prograf).
- Trial name
- NCT03511560
- Testing
- Tacrolimus Extended Release Oral Tablet, Tacrolimus
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Columbia University
Graft Rejection
Study of Alemtuzumab Versus Anti-thymocyte Globulin to Help Prevent Rejection in Kidney and Pancreas Transplantation
The purpose of this research study is to compare the effects of the two most commonly used anti-T cell induction agents(alemtuzumab and rabbit anti-thymocyte globulin) to prevent rejection in kidney and pancreas transplant…
- Trial name
- NCT00331162
- Testing
- Alemtuzumab, Anti-Thymocyte Globulin
- Where
- United States
- Volunteers
- 222 people
- Sponsor
- Wake Forest University Health Sciences
Kidney Transplantation, Primary Focal Segmental Glomerulosclerosis (FSGS)
Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients
The purpose of this study was to assess the efficacy of the bleselumab regimen (basiliximab induction, tacrolimus, steroids and bleselumab) compared with the Standard of Care (SOC) regimen (basiliximab induction, tacrolimus…
- Trial name
- NCT02921789
- Testing
- Bleselumab, Basiliximab, Mycophenolate Mofetil (MMF)
- Where
- 23 sites in United States, Canada
- Volunteers
- 67 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Proteinuria, Transplant Glomerulopathy
Acthar as Rescue Therapy for Transplant Glomerulopathy in Kidney Transplant Recipients
The goal of this study is to evaluate the benefit of ACTH (Acthar) in reducing proteinuria associated with transplant glomerulopathy in non-diabetic kidney transplant recipients.
- Trial name
- NCT02057523
- Testing
- Acthar
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- University of Illinois at Chicago
Asses Immunosuppression Modulation on Renal Recovery Post LT
Examination of Immunosuppression Adjustment Impact on Kidney Function in Liver Transplant
This is a study to help understand how well new combinations of immunosuppressive medications (medications that weaken your immune system to prevent your body from rejecting the transplanted liver) work compared to standard…
- Trial name
- NCT04104438
- Testing
- Basiliximab 20 MG
- Where
- United States
- Volunteers
- 71 people
- Sponsor
- Fady M Kaldas, M.D., F.A.C.S.
Antibody Mediated Rejection
Safety & Efficacy of Eculizumab to Prevent AMR in Living Donor Kidney Transplant Recipients Requiring Desensitization
The purpose of this trial was to determine the safety and efficacy of eculizumab in the prevention of antibody-mediated rejection (AMR) in sensitized recipients of a living donor kidney transplant requiring desensitization…
- Trial name
- NCT01399593
- Testing
- Eculizumab
- Where
- 41 sites in United States, Australia and 8 more
- Volunteers
- 102 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Graft Rejection, Kidney Transplant
Study Evaluating A Planned Transition From Tacrolimus To Sirolimus In Kidney Transplant Recipients
This study will look at the effect on long-term kidney function using tacrolimus right after a transplant and then switching to sirolimus at 3 to 5 months after the transplant.
- Conditions
- Graft Rejection, Kidney Transplant, Renal Allograft Recipients, Renal Transplant
- Trial name
- NCT00895583
- Testing
- Tacrolimus, Sirolimus
- Where
- 44 sites in United States, Argentina and 5 more
- Volunteers
- 254 people
- Sponsor
- Pfizer
Kidney Transplantation
Study Investigating Rapamune For Post-Marketing Surveillance
To provide safety and effectiveness information for Rapamune during the post-marketing period as required by Korea Food and Drug Administration (KFDA) regulations in order to identify any potential drug related treatment factors…
- Trial name
- NCT00484094
- Testing
- sirolimus
- Where
- 11 sites in South Korea
- Volunteers
- 209 people
- Sponsor
- Pfizer
End Stage Renal Disease (ESRD), Chronic Kidney Disease (CKD)
Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM)
This is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating the graft function of everolimus and reduced CNI versus MPA and standard CNI in adult de novo renal transplant recipients.
- Conditions
- End Stage Renal Disease (ESRD), Chronic Kidney Disease (CKD), Hemodialysis, Renal Replacement Therapy
- Trial name
- TRANSFORM (NCT01950819)
- Testing
- Induction therapy, Corticosteroids, EVR+rCNI
- Where
- 184 sites in United States, Argentina and 40 more
- Volunteers
- 2,037 people
- Sponsor
- Novartis Pharmaceuticals
Cirrhosis, End Stage Liver Disease
Mild Hypothermia and Acute Kidney Injury in Liver Transplantation
Acute kidney injury (AKI), or worsening kidney function, is a common complication after liver transplantation (20-90% in published studies).
- Conditions
- Cirrhosis, End Stage Liver Disease, Acute Kidney Injury, Liver Transplant; Complications
- Trial name
- MHALT (NCT03534141)
- Testing
- Esophageal cooling/warming device, Mild hypothermia, Normothermia
- Where
- 3 sites in United States
- Volunteers
- 175 people
- Sponsor
- University of California, San Francisco
Renal Transplantation
Efficacy and Safety of Everolimus With Enteric-Coated Mycophenolate Sodium (EC-MPS) in a Cyclosporine Microemulsion-free Regimen Compared to Standard Therapy in de Novo Renal Transplant Patients
The purpose of this study is to assess whether a calcineurin inhibitor (CNI)-free regimen with enteric-coated mycophenolate sodium (EC-MPS) and everolimus is as safe and well-tolerated as the standard regimen containing…
- Trial name
- NCT00154310
- Testing
- Everolimus, Cyclosporine, Enteric-coated mycophenolate sodium
- Where
- 3 sites in Germany, Switzerland
- Volunteers
- 300 people
- Sponsor
- Novartis
Diabetes, End Stage Renal Disease
Hyperglycemia in Renal Transplantation
Based on multiple prior studies, kidney transplant recipients with diabetes are at higher risk for poor initial graft function after transplant.
- Trial name
- HiRT (NCT01643382)
- Testing
- Insulin, Insulin, Asp(B28)-
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of California, San Francisco