Clinical trials: Kidney Transplantation Recipients
Liver Transplantation, Kidney Transplantation
A Study to Evaluate the Safety and Efficacy of a Modigraf® Based Immunosuppression Regimen in De Novo Pediatric Allograft Liver and Kidney Transplantation Recipients
The purpose of this study is to observe the safety and efficacy of Modigraf in de novo pediatric allograft liver and kidney transplantation recipients.
- Trial name
- NCT05153915
- Testing
- Tacrolimus granules
- Where
- 7 sites in China
- Volunteers
- 56 people
- Sponsor
- Astellas Pharma China, Inc.
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
KIDNEY TRANSPLANTATION
Comparison of Two Tacrolimus Based Immunosuppressive Regimens in Recipients Receiving Marginal Donor Kidneys
The purpose of this study is to explore the safety and efficacy of two different immunosuppressive regimens (sequential tacrolimus/mycophenolate mofetil [MMF] plus steroids versus tacrolimus plus MMF, following induction with…
- Trial name
- TIGRE (NCT00321113)
- Testing
- tacrolimus, mycophenolate mofetil, steroids
- Where
- 14 sites in Italy
- Volunteers
- 142 people
- Sponsor
- Astellas Pharma Inc
Graft Rejection, Kidney Failure
Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients
Evaluate renal graft function (based on the calculated Glomerular Filtration Rate) at 12 months after transplantation in patients receiving either a regimen of sirolimus plus mycophenolate mofetil following an antibody induction…
- Conditions
- Graft Rejection, Kidney Failure, Kidney Transplantation
- Trial name
- NCT00261820
- Testing
- tacrolimus, mycophenolate mofetil, methylprednisolone
- Volunteers
- 160 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Graft Rejection, Kidney Failure
Study Comparing Conversion From Calcineurin Inhibitors to Rapamune Versus Standard Therapy in Established Renal Allograft Recipients
The purpose of the study is to determine the effect of conversion from calcineurin inhibitor based therapy to Rapamune based therapy in patients with mild to moderate renal insufficiency.
- Conditions
- Graft Rejection, Kidney Failure, Kidney Transplantation
- Trial name
- NCT00273871
- Testing
- Cyclosporin or tacrolimus
- Volunteers
- 190 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Heart Transplantation
Efficacy and Safety of Everolimus in de Novo Heart Transplant Recipients
This study will test the safety and efficacy of everolimus on heart transplant recipients. This study is not recruiting in the United States.
- Trial name
- NCT00150046
- Testing
- Everolimus
- Where
- 2 sites in Germany, Switzerland
- Volunteers
- 176 people
- Sponsor
- Novartis Pharmaceuticals
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
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
A 6-Month Study Of CP-690,550 Versus Tacrolimus In Kidney Transplant Patients
This Phase 2 study was designed to evaluate the safety and efficacy of 2 dose levels of CP-690,550 (15 mg twice daily and 30 mg twice) against tacrolimus, in combination with basiliximab induction, mycophenolate mofetil and…
- Trial name
- NCT00106639
- Testing
- CP-690,550, tacrolimus
- Where
- 20 sites in United States
- Volunteers
- 61 people
- Sponsor
- Pfizer
Renal Failure
Induction of Donor-Specific Tolerance in Recipients of Live Donor Stem Cell Infusion (Compassionate Use)
Four subjects were treated under compassionate use provisions under this study with facilitating cell therapy (FCRx)
- Trial name
- NCT02051673
- Testing
- Biological/Vaccine: Enriched Hematopoetic Stem Cell Infusion
- Where
- United States
- Sponsor
- Talaris Therapeutics Inc.
Renal Transplantation
Extension Study on the Safety and Efficacy of Enteric-coated Mycophenolate Sodium in Kidney Transplant Recipients
This extension study is to assess the long-term safety of EC-MPS
- Trial name
- NCT00239070
- Testing
- Enteric-Coated Mycophenolate Sodium (EC-MPS)
- Volunteers
- 69 people
- Sponsor
- Novartis
Renal Transplantation
Efficacy and Safety of Enteric-coated Mycophenolate Sodium and Cyclosporine in Combination With and Without Steroids, in Adult Renal Transplant Recipients
This study will investigate the efficacy and safety of a steroid avoidance regimen in comparison with steroid treatment in combination with an initially higher dose of enteric-coated mycophenolate sodium (EC-MPS) and cyclosporine…
- Trial name
- NCT00413920
- Testing
- Enteric-coated mycophenolate sodium (EC-MPS), Prednisone
- Where
- France
- Volunteers
- 222 people
- Sponsor
- Novartis
Kidney Transplant
Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in a Cyclosporine Microemulsion Based Regimen in de Novo Living Donor Kidney Transplant Recipients
This study will evaluate the efficacy and safety of enteric-coated mycophenolate sodium (EC-MPS) in a cyclosporine microemulsion based regimen with C2 monitoring in de novo kidney transplant recipients
- Trial name
- NCT00537862
- Testing
- Enteric-Coated Mycophenolate Sodium (EC-MPS)
- Where
- 8 sites in South Korea
- Volunteers
- 200 people
- Sponsor
- Novartis Pharmaceuticals
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
Heart Transplantation, Liver Transplantation
Study to Ascertain if Prolonged Release Tacrolimus (FK506E - MR4) is Safe and Effective When Used in the Long Term and in Combination With Other Immunosuppressive Drugs in Patients Who Have Received a Transplant
The purpose of this study was to offer patients who had participated in one of the phase II PK or phase III studies on FK506E (MR4) the possibility to continue FK506E (MR4) until commercial availability of the drug and to record…
- Conditions
- Heart Transplantation, Liver Transplantation, Kidney Transplantation
- Trial name
- NCT02118896
- Testing
- FK506E
- Where
- 105 sites in United States, Australia and 21 more
- Volunteers
- 850 people
- Sponsor
- Astellas Pharma Europe Ltd.
Kidney Transplantation
Study Comparing Standard Dose and Reduced Dose Tacrolimus With Sirolimus in Renal Transplant Patients
The study evaluated renal graft function (based on the calculated creatinine clearance) 6 months after kidney transplantation in patients receiving either a regimen of 'reduced-dose' tacrolimus + sirolimus + corticosteroids or a…
- Trial name
- NCT00519116
- Testing
- Rapamune® (Sirolimus), Tacrolimus, Perioperative Corticosteroids
- Volunteers
- 150 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Kidney Diseases
Enteric-coated Mycophenolate Sodium (EC-MPS) With Reduced-dose Tacrolimus Versus EC-MPS With Standard-dose Tacrolimus in Stable Kidney Transplant Recipients
This study introduces a new optimization immunosuppressive regimen associating tacrolimus at a reduced dose and enteric-coated mycophenolate sodium at an increased dose in order to slow down renal function worsening and to…
- Trial name
- OLYMPE (NCT00284934)
- Testing
- Enteric-coated mycophenolate sodium (EC-MPS), Tacrolimus, Corticosteroids
- Where
- Switzerland
- Volunteers
- 94 people
- Sponsor
- Novartis
Kidney Transplant
A Study to Assess the Efficacy and Safety of Advagraf® Switching From Cyclosporine Between the Group That Was Treated With a 50% Reduced Corticosteroid and the Group With Maintained Corticosteroid for Stable Kidney Transplant Recipients
This study is a multicenter, randomized, comparison, open-label, phase IV study in kidney transplant recipients whose immunosuppressive regimen is converted from Cyclosporine with corticosteroid to Advagraf® with corticosteroid.
- Trial name
- COSMOS (NCT02034747)
- Testing
- Advagraf, Corticosteroid
- Where
- 9 sites in South Korea
- Volunteers
- 150 people
- Sponsor
- Astellas Pharma Korea, Inc.
Renal Transplantation
Study Comparing Conversion to Sirolimus vs. Continued Use of Calcineurin Inhibitors in Kidney Transplant Recipients
The purpose of this study is to determine the effect of conversion from calcineurin inhibitor to sirolimus based therapy on renal function.
- Trial name
- NCT00038948
- Testing
- Sirolimus, tacrolimus, Cyclosporine A
- Volunteers
- 830 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Renal Transplantation
Extension Study to Assess Tolerability and Safety of Enteric-coated Mycophenolate Sodium in Renal Transplant Recipients Who Received Mycophenolate Mofetil
This extension study is considered to allow patients being treated with EC-MPS to collect further information on the long-term safety of this drug.
- Trial name
- NCT00238966
- Testing
- Enteric-Coated Mycophenolate Sodium (EC-MPS)
- Volunteers
- 187 people
- Sponsor
- Novartis