Clinical trials: Kidney Transplantation
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
Renal Transplant
Study of Enteric-coated Mycophenolate Sodium Versus Mycophenolate Mofetil in Adult de Novo Renal Transplant Patients
Purpose of study is to compare the efficacy of enteric-coated mycophenolate sodium compared to mycophenolate mofetil in Chinese patients (study conducted in China) as measured by the incidence of biopsy proven acute rejection…
- Trial name
- NCT00149903
- Testing
- Mycophenolate sodium (enteric coated)
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Novartis Pharmaceuticals
Liver Transplantation
Efficacy of Everolimus in Combination With Tacrolimus in Liver Transplant Recipients
This trial evaluated the efficacy and safety of Everolimus in combination with tacrolimus versus a standard immunosuppressive regimen concerning kidney function in liver transplant recipients.
- Trial name
- HEPHAISTOS (NCT01551212)
- Testing
- Everolimus, Tacrolimus, Corticosteroids
- Where
- 15 sites in Germany
- Volunteers
- 339 people
- Sponsor
- Novartis Pharmaceuticals
Transplantation
A Conversion Study to Assess Safety and Efficacy of a MR4 Based Immunosuppressive Regimen in Stable Kidney Recipients
Assessment of the safety and the efficacy of a tacrolimus modified release (MR4) based immunosuppressive regimen in stable kidney transplant subjects converted on a 1:1 (mg:mg) basis from a Prograf® based immunosuppressive…
- Trial name
- NCT00384137
- Testing
- Tacrolimus
- Where
- 13 sites in France, Germany and 4 more
- Volunteers
- 128 people
- Sponsor
- Astellas Pharma Inc
Kidney Transplantation
Study Comparing Graft Function in Renal Allograft Recepients Receiving Reduced or Standard Dose CsA With Sirolimus
This study evaluated renal graft function (based on calcuated creatinine clearance) 12 months after transplantation in patients receiving either a regimen of reduced dose or standard dose cyclosporine in combination with…
- Trial name
- NCT00518375
- Testing
- Rapamune® (Sirolimus), Neoral® (Cyclosporine), Corticosteroids
- Volunteers
- 250 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Kidney Transplantation
Mycophenolate Mofetil (MMF) Discontinuation From a Tacrolimus/MMF/Steroid Triple Regimen After Kidney Transplantation
Patients after kidney transplantation received immunosuppression by Tacrolimus, MMF and steroids. In one half of the patients after 7 weeks MMF was reduced by half, and after 12 weeks it was stopped.
- Trial name
- DISTAMP (NCT00693381)
- Testing
- Tacrolimus, Mycophenolate Mofetil, methylprednisolone and prednisone
- Where
- 14 sites in Czechia, Hungary and 2 more
- Volunteers
- 152 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 Diseases, Kidney Disease, Chronic
Clinical Impact of the IBox As an Early Intervention TooL
International, multicentre, randomized 1:1 controlled trial to prove the clinical and medico economic benefits of the medical device Predigraft, by showing that the use of Predigraft could improve patient's follow-up.
- Conditions
- Kidney Diseases, Kidney Disease, Chronic, Kidney Transplant Rejection, Kidney Transplant; Complications
- Trial name
- NCT05112315
- Testing
- Predigraft
- Where
- 16 sites in Austria, France and 4 more
- Volunteers
- 507 people
- Sponsor
- Predict4Health
Kidney Transplant Recipients
Non Invasive Blood Test To Diagnose Acute Rejection After Kidney Transplantation
This is a prospective, multicenter, observational study of kidney transplant subjects where blood specimens, intended for dd-cfDNA and other future research purposes, will be drawn after transplant
- Trial name
- DART (NCT02424227)
- Where
- 14 sites in United States
- Volunteers
- 401 people
- Sponsor
- CareDx
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
Kidney Transplant
Study to Compare Pharmacokinetics of Tacrolimus Prolonged-release (PR) Capsules and Advagraf® PR Capsules in Stable Kidney Transplant Patients.
Study to compare pharmacokinetics of tacrolimus prolonged-release (PR) capsules and Advagraf® PR capsules in stable kidney transplant patients.
- Trial name
- TODAY (NCT03978494)
- Testing
- Advagraf®, Generic tacrolimus
- Where
- 13 sites in France, Germany
- Sponsor
- Sandoz
Kidney Transplant Rejection
Molecular Biomarkers in Renal Transplantation Via TruGraf® Test
The TruGraf® test is a non-invasive blood test that measures molecular gene expression profiles associated with clinical conditions previously only diagnosed by biopsy in kidney transplant recipients.
- Trial name
- NCT04398498
- Testing
- Diagnostic Test: TruGraf® Testing
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Transplant Genomics, Inc.
Kidney Transplant Rejection, Cell-free DNA
Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring
The goal of this observational study is to learn if the donor-derived cell-free DNA (dd-cfDNA) test can assess rejection in kidney transplant recipients. Participants will have blood and urine collected at their study visit.
- Trial name
- NCT07060716
- Testing
- donor-derived cell-free DNA test
- Where
- 10 sites in United States, Germany
- Volunteers
- 125 people
- Sponsor
- Insight Molecular Diagnostics
Kidney Transplantation
Global, Multicentre, Non Interventional Advagraf Conversion Registry in Kidney Transplant Patients
A study to evaluate changes over time in renal function from baseline (time of conversion) up until five years post conversion in kidney transplant patients converted from tacrolimus twice daily (BD) formulations to a once daily…
- Trial name
- CHORUS (NCT02555787)
- Testing
- Tacrolimus
- Where
- 129 sites in Australia, Austria and 23 more
- Volunteers
- 4,430 people
- Sponsor
- Astellas Pharma Europe Ltd.
Chronic Allograft Injury
A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Zampilimab in Adult Kidney Transplant Recipients With Chronic Allograft Injury
The main purpose of the study is to investigate the safety and tolerability of repeat dosing with zampilimab in kidney transplant recipients with deteriorating kidney function associated with chronic allograft injury (CAI).
- Trial name
- NCT04335578
- Testing
- Zampilimab
- Where
- 5 sites in Australia, Belgium and 2 more
- Volunteers
- 3 people
- Sponsor
- UCB Biopharma SRL
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
Ischemia-reperfusion Injury, Kidney Transplant; Complications
A Trial to Assess Efficacy and Safety of ex Vivo Allograft Admin of iCM012 Solution 2 mg/ml to Improve Its Function in Recipients of DCD Kidneys
Randomized (1:1), placebo controlled, double blind efficacy trial. 200 patients will be followed up for 12 months post transplantation.
- Trial name
- NCT06582485
- Testing
- iCM012 solution 2 mg/mL
- Volunteers
- 200 people
- Sponsor
- iCoat Medical AB
Liver Transplantation
Efficacy and Safety of Everolimus in Liver Transplant Recipients of Living Donor Liver Transplants
The purpose of this trial was to demonstrate the efficacy and safety of everolimus in combination with reduced tacrolimus, compared to tacrolimus control, in living donor liver transplant recipients.
- Trial name
- NCT01888432
- Testing
- Everolimus + reduced tacrolimus, Standard tacrolimus
- Where
- 42 sites in United States, Canada and 11 more
- Volunteers
- 285 people
- Sponsor
- Novartis Pharmaceuticals
Liver Transplantation
REnal Function in Liver Transplantation: Everolimus With Calcineurin Inhibitor (CNI)-Sparing sTrategy
The purpose of this study was, starting from the Italian clinical practice in liver transplantation, to optimize the immunosuppressive therapy, considering specific patient characteristics as alcoholic cirrhosis, hepatitis C…
- Trial name
- REFLECT (NCT02115113)
- Testing
- Everolimus, Tacrolimus
- Where
- 14 sites in Italy
- Volunteers
- 78 people
- Sponsor
- Novartis Pharmaceuticals
Delayed Graft Function, Other Complication of Kidney Transplant
I5NP for Prophylaxis of Delayed Graft Function in Kidney Transplantation
The purpose of this study is to determine whether a single administration of QPI-1002 (also known as I5NP) can prevent DGF in patients undergoing deceased donor kidney transplantation.
- Trial name
- NCT00802347
- Testing
- I5NP, Saline
- Where
- 50 sites in United States, Canada and 3 more
- Volunteers
- 374 people
- Sponsor
- Quark Pharmaceuticals