Clinical trials: Function of Renal Transplant
Heart Transplantation
Everolimus Versus Mycophenolate Mofetil in Combination With Reduced Dose Cyclosporine Microemulsion in Maintenance Heart Transplant Recipients
In this study two immunosuppressive regimens (everolimus in combination with cyclosporine microemulsion and mycophenolate mofetil with cyclosporine microemulsion) with reduced dose cyclosporine microemulsion are compared in…
- Trial name
- NCT00170859
- Testing
- Everolimus
- Where
- Germany
- Sponsor
- Novartis Pharmaceuticals
Liver Transplant
A Multicentre, Randomised, Open-label, Controlled, 12-month Follow-up Study to Assess Impact on Renal Function of an Immunosuppression Regimen Based on Tacrolimus Minimisation in Association With Everolimus in de Novo Liver Transplant Recipients.
Assuming greater efficacy in the prevention of acute rejection in the EVR arm with minimisation of TAC levels, the hypothesis of the present trial was that the introduction of EVR in combination with the minimisation of TAC…
- Trial name
- REDUCE (NCT02040584)
- Testing
- Minimisation of TAC, TAC + MMF + corticosteroids
- Where
- 20 sites in Spain
- Volunteers
- 217 people
- Sponsor
- Novartis Pharmaceuticals
Renal Transplantation
Study to Evaluate the Combination of Enteric-coated Mycophenolate Sodium (EC-MPS), Basiliximab, and C2-monitored Cyclosporine in de Novo Renal Transplant Recipients at Potential High Risk of Delayed Graft Function (DGF)
The aim of the study is to assess the short-term benefit of the combination of basiliximab, EC-MPS and cyclosporine microemulsion with C2 monitoring on the prophylaxis of acute rejection in a population of de novo renal…
- Trial name
- NCT00154232
- Testing
- Enteric-Coated Mycophenolate Sodium (EC-MPS)
- Volunteers
- 46 people
- Sponsor
- Novartis Pharmaceuticals
Delayed Graft Function
ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function
The main purpose of this study is to evaluate the safety, efficacy and tolerability of ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function.
- Trial name
- VARVARA (NCT05907096)
- Testing
- ARGX-117
- Where
- 45 sites in United States, Australia and 9 more
- Volunteers
- 103 people
- Sponsor
- argenx
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
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
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
Chronic Kidney Insufficiency
Non-interventional-study With Tacrolimus Sandoz© Capsules for Prophylaxis of Renal Graft Rejection
This non-interventional study intends to collect epidemiological data in patients with stable kidney function after renal transplantation, who receive Tacrolimus Sandoz© according to the approved indication.
- Trial name
- NCT01353417
- Testing
- In this observational study no study specific intervention is planned
- Where
- Austria
- Volunteers
- 102 people
- Sponsor
- Sandoz
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
Delayed Graft Function
YSPSL for Prevention of Delayed Graft Function Part A
Selectins have been implicated in the pathogenesis of ischemia/reperfusion (I/R)-induced kidney injury and resultant DGF. PSGL-1 is a ligand for P-, E-, and L-selectin.
- Trial name
- NCT00298181
- Testing
- YSPSL
- Where
- 10 sites in United States
- Volunteers
- 15 people
- Sponsor
- Y's Therapeutics, Inc.
Delayed Graft Function
Prevention of Delayed Graft Function Using Eculizumab Therapy (PROTECT Study)
The purpose of this study was to determine if eculizumab is safe and could be used to prevent delayed graft function (DGF) following kidney transplantation.
- Trial name
- NCT02145182
- Testing
- Eculizumab
- Where
- 78 sites in United States, Australia and 7 more
- Volunteers
- 288 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Delayed Graft Function, End Stage Renal Disease
Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults at High Risk of Delayed Graft Function (DGF) Following Kidney Allograft Transplantation
A Phase 3 Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults at High Risk of Delayed Graft Function (DGF) Following Kidney Allograft Transplantation
- Conditions
- Delayed Graft Function, End Stage Renal Disease, Deceased Donor Kidney Transplant
- Trial name
- NCT07020832
- Testing
- Pegcetacoplan
- Where
- Brazil
- Sponsor
- Apellis Pharmaceuticals, Inc.
Kidney Diseases
YSPSL for Prevention of Delayed Graft Function Part B
Selectins have been implicated in the pathogenesis of ischemia/reperfusion (I/R)-induced kidney injury and resultant delayed graft function (DGF). PSGL-1 is a ligand for P-, E-, and L-selectin.
- Trial name
- NCT00298168
- Testing
- YSPSL
- Where
- 15 sites in United States
- Volunteers
- 60 people
- Sponsor
- Y's Therapeutics, Inc.
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
Kidney Transplantation
Efficacy and Safety of AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months), in Renal Transplant Patients
This study will evaluate the efficacy and safety of AEB071 in preventing acute rejections after kidney transplantation, when combined with tacrolimus for the first 3 months and with myfortic thereafter.
- Trial name
- NCT00403416
- Testing
- AEB071, Mycophenolic Acid
- Where
- 28 sites in United States, Canada and 6 more
- Volunteers
- 215 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplantation
Freedom Study: Myfortic in Kidney Transplant Patients
The primary objective of the study is to evaluate that 3 immunosuppressant regimens will have comparable kidney function results in kidney transplant patients.
- Trial name
- NCT00101738
- Testing
- Myfortic
- Where
- 44 sites in United States, Argentina and 11 more
- Volunteers
- 342 people
- Sponsor
- Novartis Pharmaceuticals
Delayed Graft Function, DGF
Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab Administered Intravenously in Adult Participants at High Risk of Delayed Graft Function After Kidney Transplantation
The primary objective of this study is to demonstrate the efficacy of ravulizumab vs placebo in reducing the severity of DGF as measured by time to freedom from dialysis in adult participants who are at high risk of DGF after…
- Conditions
- Delayed Graft Function, DGF, Kidney Transplant
- Trial name
- AWAKE (NCT06830798)
- Testing
- Ravulizumab
- Where
- 130 sites in United States, Argentina and 16 more
- Volunteers
- 450 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Heart Transplantation
A Study of Daclizumab (Zenapax) in Combination With Mycophenolate Mofetil (CellCept) and Sirolimus in Prevention of Acute Rejection in Heart Transplant Participants
This study will evaluate the efficacy and safety of intravenous daclizumab in combination with oral mycophenolate mofetil and oral sirolimus in participants receiving a heart transplant, and at risk of impaired kidney function.
- Trial name
- NCT02554955
- Testing
- Daclizumab, Mycophenolate mofetil, Silrolimus
- Where
- 14 sites in Spain
- Volunteers
- 36 people
- Sponsor
- Hoffmann-La Roche
Liver Transplant Recipient
Extension Study to Evaluate the Long-term Efficacy and Safety of Everolimus in Liver Transplant Recipients
The reason for this extension is to evaluate the long-term safety and efficacy of two concentration-controlled everolimus regimen in de novo liver transplant recipients.
- Trial name
- NCT01150097
- Testing
- Tacrolimus (reduced tacrolimus), Everolimus (reduced tacrolimus), Tacrolimus (tacrolimus elimination)
- Where
- 57 sites in United States, Argentina and 14 more
- Volunteers
- 284 people
- Sponsor
- Novartis Pharmaceuticals