Clinical trials: Transplantation, Kidney
Kidney Transplantation
A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Kidney Transplantation
The patients about to undergo kidney transplantation will be randomized to one of the following two group: Group FK506MR: FK506MR/MMF/steroid; Group Prograf® : Prograf® /MMF/steroid. The treatment period is 3 months( 12 weeks)
- Trial name
- NCT00481819
- Testing
- FK506MR, Prograf, Mycophenolate Mofetil
- Where
- 9 sites in China
- Volunteers
- 240 people
- Sponsor
- Astellas Pharma Inc
Kidney Transplantation Cytomegalovirus (CMV) Negative Recipients
A Study to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving an Organ From a CMV-Seropositive Donor
The purpose of this study was to evaluate the efficacy of ASP0113 compared to placebo in reducing the incidence of cytomegalovirus (CMV) viremia in CMV-seronegative subjects receiving a kidney from a CMV-seropositive donor.
- Trial name
- NCT01974206
- Testing
- ASP0113
- Where
- 53 sites in United States, Australia and 4 more
- Volunteers
- 150 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Kidney Preservation and Transportation
Prospective, Single-Arm, Study to Assess the Safety and Performance of the TB1-K Device for Organ Preservation in Donor Kidneys for Transplantation
TB1-K Device is an organ preservation and transportation system, using ultrasound technology with a cooling system to preserve the organ in optimal conditions during transport to the transplant recipient.
- Trial name
- EMERGE (NCT03600285)
- Testing
- TB1-K
- Where
- 3 sites in Spain
- Volunteers
- 32 people
- Sponsor
- Transplant Biomedicals, S.L.
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
Kidney Transplantation
Efficacy, Safety and Tolerability of AEB071 Versus Cyclosporine in the Novo Renal Transplant Recipients
This study will assess safety and efficacy of AEB071 combined with everolimus in a CNI-free (calcineurin inhibitor) regimen in renal transplant recipients.
- Trial name
- AEB071 (NCT00504543)
- Testing
- AEB071, Certican, Neoral
- Where
- 26 sites in Argentina, Australia and 15 more
- Volunteers
- 311 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
Kidney Transplantation
To Compare the Effects of Immediate-release Tacrolimus and Astagraf XL on Donor-Specific Antibody (DSA) Formation and the Development of Immune Activation (IA) in de Novo Kidney Transplant Recipients
This study compared the incidence of a two-part composite endpoint consisting of de novo donor specific antibody (DSA) formation or a designation of immune activation (IA) on peripheral blood molecular profiling in participants…
- Trial name
- ASTOUND (NCT02723591)
- Testing
- Tacrolimus, Tacrolimus immediate release
- Where
- 30 sites in United States
- Volunteers
- 599 people
- Sponsor
- Astellas Pharma Global Development, Inc.
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
Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Renal Transplant Patients
The aim of MYFORMS is to assess efficacy and safety on clinical outcomes of EC-MPS in combination with Cyclosporine microemulsion (CsA-ME) in kidney transplant recipients.
- Trial name
- NCT00239083
- Testing
- Enteric-Coated Mycophenolate Sodium (EC-MPS)
- Where
- Switzerland
- Volunteers
- 40 people
- Sponsor
- Novartis
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 Transplantation
Evaluation of Immunobiogram® as a Tool in Adjustment of Immunosuppressant Therapy for Renal Transplant
The trial is an observational, multi-center study to determine if a new blood test (Immunobiogram®) done after renal transplant can help predict how well the immune system is working and responding to a new kidney.
- Trial name
- TRANSBIO (NCT03562845)
- Testing
- NA-Observational only
- Where
- United States
- Volunteers
- 164 people
- Sponsor
- Biohope Scientific Solutions for Human Health, S.L.
Kidney Transplantation in Highly Sensitized Patients
Renal Function in Highly Sensitized Patients 1 Year After Desensitization With Imlifidase Prior to DD Kidney Tx
An open-label, controlled, randomized Phase 3 trial evaluating 12-month kidney function in highly sensitized (cPRA ≥99.9%) kidney transplant patients with positive crossmatch against a deceased donor, comparing desensitization…
- Trial name
- ConfIdeS (NCT04935177)
- Testing
- Imlifidase, PLEX, IVIg
- Where
- 25 sites in United States
- Volunteers
- 64 people
- Sponsor
- Hansa Biopharma AB
Kidney Transplantation
A Study of TCD601 in the Induction of Tolerance in Renal Transplantation (PERSPECTIVE)
The purpose of this study is to evaluate if TCD601 can induce allogeneic tolerance in living donor renal transplant recipients
- Trial name
- PERSPECTIVE (NCT04803058)
- Testing
- TCD601
- Where
- 3 sites in United States, South Korea
- Volunteers
- 7 people
- Sponsor
- ITB-Med LLC
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