Clinical trials: Kidney Transplantation Recipients
Pharmacokinetics Study in de Novo Kidney Transplantation
Comparison of a Tacrolimus Hexal® Based Regimen Versus a Prograf® Based Regimen in de Novo Renal Transplant Recipients
The purpose of this study was to investigate if Tacrolimus Hexal® has similar pharmacokinetic properties compared to Prograf® in de novo renal transplant patients and whether the comparable exposure resulted in similar renal…
- Trial name
- Spartacus (NCT01649427)
- Testing
- Prograf, Tacrolimus Hexal
- Where
- 5 sites in Germany
- Volunteers
- 73 people
- Sponsor
- Novartis Pharmaceuticals
Renal Transplantation
A Twelve-month, Multicenter, Open-label, Randomized Study of the Safety, Tolerability and Efficacy of Everolimus With Basiliximab, Corticosteroids and Two Different Exposure Levels of Tacrolimus in de Novo Renal Transplant Recipients
This study is designed to evaluate whether tacrolimus dose reduction in de novo renal recipients receiving everolimus can preserve renal function while maintaining efficacy.
- Trial name
- NCT00369161
- Testing
- Everolimus (RAD001), Tacrolimus, Basiliximab
- Where
- Switzerland
- Volunteers
- 228 people
- Sponsor
- Novartis
Kidney Transplantation, Adverse Effects
Safety and Efficacy of Basiliximab in Calcineurin Inhibitor Intolerant Long-term Kidney Transplant Recipients Treated With Mycophenolic Acid and Steroids
The long-term use of calcineurin inhibitors (CNI) in patients who have received a kidney transplantation is associated with renal dysfunction and hypertension.
- Trial name
- NCT00284947
- Testing
- basiliximab, MMF/EC-MPS, Corticosteroids
- Where
- Switzerland
- Volunteers
- 7 people
- Sponsor
- Novartis
Kidney Transplant, Immunosuppresion
Immunosuppression Optimization Using The Prospera Assay In Kidney Transplant Recipients (IMPAKT)
IMPAKT is a research study that looks at whether a blood test called Prospera™ can help doctors better adjust anti-rejection medications, compared to the usual way doctors manage these medications without using this test.
- Trial name
- IMPAKT (NCT07718633)
- Testing
- Prospera Immunosuppression Optimization
- Volunteers
- 750 people
- Sponsor
- Natera, Inc.
Kidney Transplantation
A One-year, Open Label Study to Investigate the Safety and the Effect of Enteric-coated Mycophenolate Sodium (EC-MPS) in Combination With Cyclosporine Microemulsion in de Novo Kidney Transplant Recipients.
The study is a one-year prospective, open-label, safety and efficacy study. De novo renal transplant recipients will be receiving cyclosporine, 1.44g EC-MPS (720 mg b.i.d.), and corticosteroids .The study will consist of a…
- Trial name
- NCT00154245
- Testing
- Enteric-Coated Mycophenolate sodium (EC-MPS)
- Volunteers
- 20 people
- Sponsor
- Novartis
End-stage Renal Disease
A Study of Thymoglobuline® Induction Therapy in Adult Recipients of Donated After Cardiac Death Kidney Transplant
Primary Objective: To investigate the efficacy of the standard dose of Thymoglobuline® induction therapy for preventing acute rejection (AR) after transplantation among recipients of Donated after Cardiac Death (DCD) kidney…
- Trial name
- START-DCD (NCT03099122)
- Testing
- Rabbit Anti-thymocyte Immunoglobulin, Tacrolimus, Methylprednisolone
- Where
- China
- Volunteers
- 115 people
- Sponsor
- Sanofi
Kidney Transplantation
A Study to Evaluate the Effect of ASP8597 in Adult Kidney Transplant Patients
The purpose of this study is to evaluate the efficacy, safety and tolerability of a single intravenous dose of ASP8597 in kidney transplant recipients.
- Trial name
- NCT01442337
- Testing
- ASP8597
- Where
- 19 sites in United States
- Volunteers
- 21 people
- Sponsor
- Astellas Pharma Inc
Liver Transplantation
Study of the Effect of Everolimus Immunosuppressive Combination Therapies on Renal Function When Used as a Maintenance Treatment for Liver Transplant Patients.
A 24-month multi-center, open-label, randomized, controlled study to evaluate the evolution of renal function in maintenance liver transplant recipients receiving everolimus plus reduced TAC or everolimus plus mycophenolate…
- Trial name
- Prometheus (NCT03596970)
- Testing
- TAC withdrawal, Everolimus with reduced TAC
- Sponsor
- Novartis Pharmaceuticals
Kidney Failure, Graft vs Host Disease
Study Evaluating Sirolimus in Kidney Transplant Recipients.
Renal function at 12 months assessed by calculated creatinine clearance.
- Trial name
- NCT00167947
- Testing
- Cyclosporine, Steroids, Rapamune (Sirolimus)
- Where
- 14 sites in Italy
- Volunteers
- 150 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Liver Transplantation
Preservation of Renal Function in Liver Transplant Recipients With Certican Therapy
The study is designed to show that everolimus initiation together with reduction and thereafter discontinuation of calcineurin inhibitor (CNI) will improve significantly renal function in de novo liver transplant recipients as…
- Trial name
- NCT00378014
- Testing
- everolimus, basiliximab, CNI
- Where
- 16 sites in Austria, Germany and 2 more
- Volunteers
- 276 people
- Sponsor
- Novartis Pharmaceuticals
Organ Transplantation, Renal Transplantation
Everolimus in a Cyclosporine Microemulsion-free Regimen Compared to a Low-dose Cyclosporine Microemulsion Regimen, in de Novo Kidney Transplant Patients
The purpose of this study is to evaluate the safety and efficacy of everolimus in combination with basiliximab, and steroids with and without cyclosporine microemulsion in de novo kidney transplant recipients.
- Trial name
- CERTES02 (NCT00154284)
- Testing
- Everolimus (Certican), Cyclosporine (Neoral), Steroid
- Volunteers
- 114 people
- Sponsor
- Novartis
Renal Failure
Induction of Donor Specific Tolerance in Recipients of Live Donor Kidney Allografts by Donor Stem Cell Infusion
The goal of this research study is to establish chimerism and avoid graft-versus-host disease in patients with kidney failure allowing a reduction or cessation of immune-suppressive therapy.
- Trial name
- NCT00498160
- Testing
- Enriched Hematopoietic Stem Cell Infusion
- Where
- 2 sites in United States
- Volunteers
- 38 people
- Sponsor
- Talaris Therapeutics Inc.
Cytomegalovirus Disease, Kidney Transplant Infection
A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus
This was a randomized, double-blind, double-dummy, parallel-group, multicenter study of the efficacy, safety, and tolerability of oral brincidofovir (BCV) versus valganciclovir for the prevention of cytomegalovirus (CMV) disease…
- Trial name
- NCT02439957
- Testing
- Brincidofovir, Valganciclovir
- Where
- 3 sites in United States
- Volunteers
- 6 people
- Sponsor
- Jazz Pharmaceuticals
Liver Transplantation
Liver Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Sirolimus in Recipients of a Liver Transplant
This two-arm study will assess the efficacy and safety of a long-term calcineurin inhibitor-free maintenance regimen with CellCept and sirolimus in recipients of an orthotropic liver transplant.
- Trial name
- NCT00118742
- Testing
- mycophenolate mofetil [CellCept], Tacrolimus, Cyclosporine
- Where
- 46 sites in United States, Canada
- Volunteers
- 293 people
- Sponsor
- Hoffmann-La Roche
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.
Renal Transplant Failure and Rejection
A Study Comparing Siplizumab With Rabbit Anti-Thymocyte Globulin to Help the Body Accept a Kidney Transplant
The goal of this clinical trial is to learn if siplizumab can prevent rejection of a kidney transplant in adult participants with end stage kidney disease.
- Trial name
- MODERNIZE1 (NCT07508787)
- Testing
- Siplizumab, Rabbit anti-thymocyte globulin
- Where
- 14 sites in United States, Brazil and 1 more
- Volunteers
- 120 people
- Sponsor
- Nefro Avillion Clinical Development, LLC
Kidney Transplantation
Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients
The purpose of the study in de novo renal transplant patients is to evaluate the effect on renal function of an optimized new regimen in comparison with the standard everolimus exposure plus a low-dose cyclosporine microemulsion…
- Trial name
- NCT00170885
- Testing
- Everolimus
- Where
- Switzerland
- Sponsor
- Novartis
Kidney Transplant Rejection, End Stage Renal Disease
Safety & Tolerability Study of Chimeric Antigen Receptor T-Reg Cell Therapy in Living Donor Renal Transplant Recipients
The purpose of this study is to evaluate the safety and tolerability of TX200-TR101 and its effects on the donated kidney in living donor kidney transplant recipients.
- Trial name
- STEADFAST (NCT04817774)
- Testing
- TX200-TR101
- Where
- 5 sites in Belgium, Netherlands and 1 more
- Volunteers
- 26 people
- Sponsor
- Sangamo Therapeutics
Graft Rejection
A Pilot Study to Evaluate the Use of C1 Esterase Inhibitor (Human) in Patients With Acute Antibody-Mediated Rejection
The purpose of this research study is to evaluate the safety, effect, and pharmacology of C1 Esterase Inhibitor (human) in kidney transplant patients with acute Antibody-Mediated Rejection (AMR).
- Trial name
- NCT01147302
- Testing
- C1 Esterase Inhibitor (Human)
- Where
- 5 sites in United States, Germany
- Volunteers
- 18 people
- Sponsor
- Shire
Kidney Transplantation
A Study to Assess the Safety and Efficacy of a Tacrolimus Based Immunosuppressive Regimen in Stable Kidney Transplant Recipients Converted From Cyclosporine Based Immunosuppressive Regimen
The objective of this study is to observe and evaluate the change in renal function following conversion from cyclosporine-based immunosuppressive regimen to tacrolimus-based one.
- Trial name
- NCT02963103
- Testing
- Tacrolimus
- Where
- South Korea
- Volunteers
- 13 people
- Sponsor
- Astellas Pharma Korea, Inc.