Clinical trials: Renal Allograft Recipients
Kidney Failure, Graft vs Host Disease
A Study Comparing the Withdrawal of Steroids or Tacrolimus in Kidney Transplant Recipients
This study evaluates two different immunosuppression drug regimens in patients with a recent kidney transplant. Patients initially received a regimen of Sirolimus, Tacrolimus and Prednisone and then randomized to discontinue…
- Trial name
- NCT00195429
- Testing
- Tacrolimus, Sirolimus, prednisone
- Where
- Brazil
- Volunteers
- 47 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Renal Transplant
Belatacept to Prevent Organ Rejection in Kidney Transplant Patients
Belatacept is an experimental medication shown in clinical trials to have immune system suppression properties in people who have had renal (e.g., kidney) transplants.
- Trial name
- BESTT (NCT00346151)
- Testing
- Belatacept, Sirolimus, Anti-thymocyte globulin
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
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
Efficacy, Safety and Evolution of Cardiovascular Parameters in Renal Transplant Recipients
The purpose of this study was to determine whether an early Calcineurin Inhibitor (CNI) to everolimus conversion at 10-14 weeks post transplantation improves renal allograft function without compromising efficacy compared to…
- Trial name
- ELEVATE (NCT01114529)
- Testing
- Everolimus, Prograf or Neoral
- Where
- 77 sites in Argentina, Australia and 19 more
- Volunteers
- 828 people
- Sponsor
- Novartis Pharmaceuticals
Cytomegalovirus Infections
IMPACT Study: A Study of Valcyte (Valganciclovir) for Prevention of Cytomegalovirus Disease (CMV) in Kidney Allograft Recipients
This study will determine the relative efficacy and safety of up to 100 days Valcyte prophylaxis relative to up to 200 days Valcyte prophylaxis when given for the prevention of CMV disease in high-risk (D+/R-) kidney allograft…
- Trial name
- IMPACT (NCT00294515)
- Testing
- Valganciclovir
- Where
- 80 sites in United States, Australia and 11 more
- Volunteers
- 326 people
- Sponsor
- Hoffmann-La Roche
Kidney Transplant, Delayed Graft Function
Tacrolimus to Sirolimus Conversion for Delayed Graft Function
The objective of this study is to evaluate the safety and efficacy of conversion from tacrolimus to sirolimus early after kidney transplantation in patients with delayed graft function (DGF)and slow graft function (SGF) in…
- Trial name
- RAPA (NCT00931255)
- Testing
- Tacrolimus, Sirolimus
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- University of Maryland, Baltimore
Inflammation
Open Label Comparative Study Of De Novo Renal Allograft Recipients Receiving CSA + MMF + Corticosteroids Versus CSA + Rapamune + Corticosteroids
To compare the safety and efficacy of cyclosporine (CsA) + mycophenolate mofetil (MMF) + corticosteroids © to CsA + Rapamune + Cs with CsA elimination in the Rapamune arm with the introduction of MMF in de novo renal allograft…
- Trial name
- NCT01601821
- Testing
- CsA+Rapamune+CS, CsA+MMF+CS
- Where
- 4 sites in Iran
- Volunteers
- 245 people
- Sponsor
- Pfizer
Renal Failure
Multicenter, Prospective, Rand, PK Study of LCP-Tacro™ Compared to Prograf® Capsules in De Novo Adult Kidney Transplant
The purpose of this study is to evaluate the pharmacokinetics of LCP-Tacro tablets administered once-daily compared to Prograf capsules administered twice-daily after kidney transplantation.
- Trial name
- NCT01666951
- Testing
- LCP-Tacro tablets, Prograf
- Where
- 13 sites in United States
- Volunteers
- 36 people
- Sponsor
- Veloxis Pharmaceuticals
Renal Function
Evaluation of Early Conversion to Everolimus From Cyclosporine in de Novo Renal Transplant Recipients
This study is designed to evaluate if early conversion to everolimus from cyclosporine in de novo renal transplant recipients can improve long-term renal function and slow down the progression of chronic allograft nephropathy
- Trial name
- NCT00634920
- Testing
- everolimus, cyclosporine A, Enteric Coated Mycophenolate Sodium (EC-MPS)
- Where
- 8 sites in Denmark, Norway and 1 more
- Volunteers
- 204 people
- Sponsor
- Novartis Pharmaceuticals
Transplant Rejection, Renal Transplantation
Study To Evaluate Pharmacokinetics Of Sirolimus In Stable Renal Transplant Recipients
Sirolimus, 1 mg, white, triangular tablets (Rapamune®) was approved on 03 April 2007 in China for prophylaxis of organ rejection in renal transplantation.
- Trial name
- NCT01236378
- Testing
- Sirolimus
- Where
- 2 sites in China
- Volunteers
- 24 people
- Sponsor
- Pfizer
Diabetes Mellitus, Type I
Study of Islet Transplantation in Type 1 Diabetic Kidney Transplant Recipients
The purpose of the study is to learn if islet transplantation is an effective treatment for Type 1 diabetes in people who have had a kidney transplant.
- Trial name
- NCT00888628
- Testing
- Purified Pancreatic Islets, Etanercept
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Massachusetts General Hospital
Chronic Allograft Nephropathy, Chronic Kidney Disease
Treatment of Autonomous Hyperparathyroidism in Post Renal Transplant Recipients
Hyperparathyroidism (HPT) is common in people with a kidney transplant. Patients with HPT often have high parathyroid hormone (PTH) levels and may have large parathyroid glands in the neck.
- Conditions
- Chronic Allograft Nephropathy, Chronic Kidney Disease, Chronic Renal Failure, Disordered Mineral Metabolism
- Trial name
- NCT00975000
- Testing
- Cinacalcet
- Where
- 51 sites in United States, Australia and 9 more
- Volunteers
- 114 people
- Sponsor
- Amgen
Kidney Transplant, Kidney Transplant Recipient
Rituximab in Renal Allograft Recipients Who Develop Early De Novo Anti-HLA Alloantibodies
The purpose of this study is to determine whether treatment with rituximab (anti-CD20, Rituxan®, MabThera®) in individuals who develop new anti-HLA antibodies after renal (kidney) transplant will promote longer-term survival of…
- Conditions
- Kidney Transplant, Kidney Transplant Recipient, Graft Function/Survival, de Novo HLA Antibodies Development
- Trial name
- NCT00307125
- Testing
- Rituximab plus immunosuppression
- Where
- 17 sites in United States
- Volunteers
- 757 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Organ Transplantation
Belatacept Post Depletional Repopulation to Facilitate Tolerance
Acute rejection is a common problem after a kidney transplant. Rejection can occur when the kidney recipient's immune system tries to attack (or reject) the new kidney.
- Trial name
- NCT00565773
- Testing
- Belatacept, Sirolimus, Alemtuzumab
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- Allan D Kirk, MD, PhD
Renal Transplantation
Study Evaluating The Use Of Sirolimus In Recipients Of Kidney Allografts From Expanded Criteria Donors (ECD)
The purpose of this observational study is to examine the clinical outcomes of the use of sirolimus as base therapy in kidney allograft recipients from Expanded Criteria Donors (ECD) under conditions of routine clinical practice.
- Trial name
- NCT00697112
- Testing
- Sirolimus
- Where
- 8 sites in Argentina
- Volunteers
- 53 people
- Sponsor
- Pfizer
Kidney Transplant
A Study Of CP-690,550 In Stable Kidney Transplant Patients
This was a Phase 1 dose escalation study to evaluate the safety, tolerability and pharmacokinetics of 28-day treatment of CP-690,550 in stable renal allograft recipients.
- Trial name
- NCT01710033
- Testing
- CP-690,550 5 mg BID, CP-690,550 15 mg BID, CP-690,550 30 mg BID
- Where
- 11 sites in United States
- Volunteers
- 28 people
- Sponsor
- Pfizer
Kidney Transplantation
CAMPath and BELimumab for Transplant Tolerance in Sensitized Kidney Transplant Recipients
The purpose of this research study is to determine whether kidney transplant recipients who receive belimumab (Benlysta®), combined with the standard of care medications for kidney transplant recipients, is safe and effective in…
- Trial name
- CAMPBEL (NCT03591380)
- Testing
- Belimumab
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- University of Wisconsin, Madison
Kidney Transplantation
Extension Study Of Stage 1 Subjects Of Study A3921009 For The Prevention Of Acute Rejection In Kidney Transplant Patient
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
- NCT00263328
- Testing
- Tacrolimus, CP-690,550
- Where
- 27 sites in United States
- Volunteers
- 46 people
- Sponsor
- Pfizer
Renal Transplant
Study Evaluating Rapamune® Maintenance Regimen
Primary : To evaluate the efficacy of sirolimus assessed by the incidence of biopsy-confirmed acute rejection episode at 6 months after transplantation in Korean renal transplantation recipients. Secondary : 1.
- Trial name
- NCT00478608
- Testing
- Sirolimus (Rapamune®)
- Where
- 9 sites in South Korea
- Volunteers
- 79 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer