Clinical trials: Kidney Transplantation Recipients
COVID-19
Immunogenicity and Safety of a Booster Dose of the SpikoGen Vaccine in Kidney Transplant Recipients After Two Doses of Sinopharm Vaccine
This is an open-label, single-arm clinical trial designed to evaluate the immunogenicity and safety of a booster dose of an adjuvanted recombinant SARS-CoV-2 spike protein subunit vaccine (SpikoGen) produced by CinnaGen Co.
- Trial name
- NCT05285384
- Testing
- SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant
- Where
- Iran
- Volunteers
- 43 people
- Sponsor
- Cinnagen
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
Antibody-Mediated Rejection (AMR)
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-mediated rejection (AMR) is a major cause of worsening kidney function after a kidney transplant (kidney allograft dysfunction) and can lead to kidney failure.
- Trial name
- NCT07613359
- Testing
- Mezagitamab
- Where
- 35 sites in United States, China and 3 more
- Volunteers
- 36 people
- Sponsor
- Takeda
Kidney Transplantation
A Study to Evaluate the Safety and Efficacy of Prograf/FK778 and Prograf/MMF in de Novo Kidney Transplant Recipients
A study to evaluate the safety and efficacy of Prograf/FK778 in de novo kidney transplant patients
- Trial name
- NCT00282230
- Testing
- FK778
- Where
- 23 sites in United States
- Volunteers
- 150 people
- Sponsor
- Astellas Pharma Inc
Heart Transplantation
A Study Investigating the Renal Tolerability, Efficacy, and Safety of a CNI-free Versus a Standard Regimen in de Novo Heart Transplant (HTx) Recipients
This study will assess whether a calcineurin inhibitor (CNI)-free regimen with everolimus and mycophenolic acid is associated with a better renal outcome as compared to the standard regimen containing cyclosporine A (which…
- Trial name
- MANDELA (NCT00862979)
- Testing
- Everolimus (EVR), cyclosporine A (CyA), tacrolimus (TAC)
- Where
- 9 sites in Germany
- Volunteers
- 162 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplantation
A Safety and Efficacy Study of FCR001 Cell Therapy in Previously Transplanted Living Donor Kidney Recipients
An open-label study to assess the safety, tolerability, and efficacy of FCR001 cell therapy in adult recipients 3-12 months after kidney transplantation from a living donor.
- Trial name
- FREEDOM-2 (NCT01649388)
- Testing
- FCR001
- Where
- 3 sites in United States
- Sponsor
- Talaris Therapeutics Inc.
Chronic Renal Failure
Efficacy and Safety of Everolimus+EC-MPS After Early CNI Elimination vs EC-MPS +Tacrolimus in Renal Transplant Recipients
The primary objective of this trial is to show non-inferiority of a CNI-free regimen with respect to the renal function at Month 9 post Tx assessed by glomerular filtration rate - Nankivell method - as compared to the standard…
- Trial name
- NCT00965094
- Testing
- Everolimus, Tacrolimus (FK506), Basiliximab
- Where
- 3 sites in Israel
- Volunteers
- 36 people
- Sponsor
- Novartis Pharmaceuticals
Pancreas Transplantation, Kidney Transplantation
Gastrointestinal and Health-related Quality of Life Outcomes in Patients With Simultaneous Pancreas-Kidney Transplants
Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients.
- Trial name
- NCT00267150
- Testing
- Enteric-coated mycophenolate sodium (EC-MPS)
- Where
- Germany
- Volunteers
- 31 people
- Sponsor
- Novartis Pharmaceuticals
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
Kidney Transplant Rejection
Cellular Immunotherapy in Recipients of Human Leukocyte Antigen (HLA)-Mismatched, Living Donor Kidney Transplants
The Phase 2 primary objective is to evaluate achievement of persistent mixed chimerism and withdrawal of at least one immunosuppression drug for a minimum of 6 months with no episodes of biopsy-proven acute rejection or…
- Trial name
- NCT03605654
- Testing
- MDR-102, Immunosuppressive Agents
- Sponsor
- Medeor Therapeutics, Inc.
Renal Transplantation
A Study of TCD601 in de Novo Renal Transplant Recipients
The purpose of this study is to evaluate the safety and efficacy of TCD601 in combination with Belatacept when compared to standard of care immunosuppression therapy in de novo renal transplant patients.
- Trial name
- ASCEND (NCT05669001)
- Testing
- TCD601, belatacept, ATG
- Where
- 18 sites in United States
- Volunteers
- 76 people
- Sponsor
- ITB-Med LLC
Respiratory Syncytial Virus Infections
A Study on the Immune Response and Safety of an RSV Vaccine When Given to Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant and Are at an Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease and Compared to Healthy Adults 50 Years of Age and Above
The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicity of the RSVPreF3 OA investigational vaccine in an immunocompromised (lung and renal transplant recipients) population and assess whether a…
- Trial name
- RSV OA=ADJ-023 (NCT05921903)
- Testing
- RSVPreF3 OA Investigational Vaccine
- Where
- 46 sites in United States, Australia and 6 more
- Volunteers
- 386 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Kidney Transplantation
An Open Study Assessing Bioavailability of a Modified Formulation of Tacrolimus in Kidney Transplant Recipients
The purpose of this study is to evaluate the effect of food on the oral bioavailability of tacrolimus modified release (MR4) capsules together with a standard continental breakfast.
- Trial name
- NCT00865137
- Testing
- Tacrolimus, modified release
- Where
- Netherlands
- Volunteers
- 27 people
- Sponsor
- Astellas Pharma Inc
Kidney Transplant Recipients
A Study to Evaluate the Efficacy and Safety in Kidney Transplant Recipients When Changed From Cyclosporine to Tacrolimus Prolonged-release Capsule or Tacrolimus Capsule
KTx recipients receiving cyclosporine-based immunosuppressive therapy, and in the opinion of the investigator would benefit from switch to a tacrolimus-based immunosuppression, will switch the immunosuppressive therapy to a…
- Trial name
- NCT02268201
- Testing
- Advagraf, Prograf
- Where
- 7 sites in China
- Volunteers
- 17 people
- Sponsor
- Astellas Pharma China, Inc.
Skin Neoplasms, Kidney Transplantation
Study Evaluating the Effect of Sirolimus on Non-Melanoma Skin Cancer in Kidney Transplant Recipients
The purpose of this study is to determine the effect of sirolimus on the prevention of new non-melanoma skin cancer (NMSC) in kidney transplant recipients.
- Trial name
- NCT00129961
- Testing
- sirolimus, cyclosporine or tacrolimus
- Where
- 23 sites in United States, Australia and 2 more
- Volunteers
- 86 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
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
BK Viremia; BKV DNAemia
Safety, Tolerability and Efficacy of AntiBKV as Treatment of BKV Infection in Kidney Transplant Recipients
The purpose of this study is to evaluate the safety, tolerability, and efficacy of AntiBKV in reducing BKV DNAemia and progression to biopsy-confirmed BKVAN in kidney transplant recipients.
- Trial name
- SAFE KIDNEY II (NCT05769582)
- Testing
- Anti-BK polyomavirus (AntiBKV)
- Where
- 23 sites in United States
- Volunteers
- 95 people
- Sponsor
- Memo Therapeutics AG
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
Kidney Transplant
Clinical Outcome of Delayed or Standard Prograf Together With Induction Therapy Followed by Conversion to Advagraf in Donation After Cardiac (or Circulatory) Death (DCD) Kidney Transplant Recipients
The purpose of this study is to confirm non-inferiority of delayed Prograf treatment to standard Prograf treatment in the incidence of delayed graft function (DGF) within 1 week between the 2 immunosuppressive (IS) treatment…
- Trial name
- NCT03644485
- Testing
- Tacrolimus immediate-release formulation, Tacrolimus prolonged-release formulation, Induction therapy
- Where
- 14 sites in China
- Volunteers
- 284 people
- Sponsor
- Astellas Pharma China, Inc.
Kidney Transplantation
Kidney Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Kidney Transplant Recipients
This 2-arm study recruited kidney transplant patients who were receiving standard care of calcineurin inhibitors (CNIs, tacrolimus or cyclosporine), CellCept (1.0-1.5 g twice daily) and corticosteroids.
- Trial name
- NCT00121810
- Testing
- mycophenolate mofetil [CellCept], Corticosteroids, Calcineurin inhibitors
- Where
- 36 sites in United States
- Volunteers
- 305 people
- Sponsor
- Hoffmann-La Roche