Clinical trials: Kidney Transplantation Recipients
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 Transplantation
Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients
This study was to compare CFZ533 to tacrolimus (TAC) in prevention of organ rejection in kidney transplant.
- Trial name
- CIRRUS I (NCT03663335)
- Testing
- CFZ533 - Cohort 1/Cohort 2, Mycophenolate Mofetil (MMF), Corticosteroids (CS)
- Where
- 74 sites in United States, Argentina and 18 more
- Volunteers
- 418 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplant Recipients, BK Virus
An Open Study on the Preventive Effect of Early Mizoribine Conversion on BKV Nephropathy in Renal Transplant Recipients
This study is divided into two parts: ① Part I was a retrospective observational study. Kidney transplant recipients infected with BK virus (BKV) in the First Affiliated Hospital of Sun Yat-sen University from 2015 to 2021 were…
- Trial name
- NCT05293704
- Testing
- Mizoribine
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Lee's Pharmaceutical Limited
Cytomegalovirus Prophylaxis
A Clinical Study of Letermovir (MK-8228) in Children and Adolescents Who Receive a Kidney Transplant (KT) (MK-8228-077)
Researchers are looking for a way to prevent cytomegalovirus (CMV) in children and adolescents who receive a kidney transplant (KT) and weigh less than 40 kilograms (88.2 pounds).
- Trial name
- NCT07199465
- Testing
- Letermovir
- Where
- 22 sites in United States
- Volunteers
- 40 people
- Sponsor
- Merck Sharp & Dohme LLC
Kidney Transplantation
Comparing Efficacy & Safety of Tacrolimus & MMF With/Without Induction in the Elderly Following Kidney Transplantation.
Primary objective of this study is to compare the renal function as well as the incidence of renal dysfunction, the incidence of death, graft loss and acute rejection.
- Trial name
- SENIOR (NCT00296309)
- Testing
- Tacrolimus
- Where
- 33 sites in Belgium, France and 5 more
- Volunteers
- 267 people
- Sponsor
- Astellas Pharma Inc
Kidney Transplantation
Envarsus® Once Daily With Everolimus in Elderly Kidney Transplant Recipients: Pharmacokinetic and Clinical Study
Prospective, single-arm, open-label, multicentre study with the principal aim to estimate tacrolimus pharmacokinetic parameters in elderly de-novo kidney transplant recipients of ECD (Extended Criteria Donor) kidney grafts…
- Trial name
- NCT02970630
- Testing
- Tacrolimus, Everolimus
- Where
- 6 sites in Italy
- Volunteers
- 28 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Renal Transplantation
Study to Evaluate the Efficacy, Safety and Tolerability of Everolimus in de Novo Renal Transplant Recipients Participating in the Eurotransplant Senior Program
This study wants to address whether a calcineurin-inhibitor (CNI)-free regimen six weeks after transplantation for Eurotransplant Senior Program (ESP) patients is as safe and well tolerated as standard treatment but optimizing…
- Trial name
- Senator (NCT00956293)
- Testing
- Basiliximab, Enteric Coated Mycophenolic Acid (MPA), RAD001
- Where
- 9 sites in Germany
- Volunteers
- 207 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplantation
Study Comparing Standard Dose and Reduced Dose Tacrolimus + Sirolimus + Corticosteroids in Renal Allograft Recipients
This study evaluated renal graft function based on calculated creatinine clearance at 6 months after transplantation in patients receiving a regimen of 'reduced' or 'standard' dose tacrolimus plus sirolimus and corticosteroids.
- Trial name
- NCT00518271
- Testing
- Rapamune® (Sirolimus), Tacrolimus, Corticosteroids
- Volunteers
- 120 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Kidney Transplantation, Graft Rejection
Efficacy and Safety Study of Everolimus Plus Reduced Cyclosporine Versus Mycophenolic Acid Plus Cyclosporine in Kidney Transplant Recipients
The purpose of this study was to compare the safety and efficacy of three immunosuppressive treatment regimens following a kidney transplant.
- Trial name
- NCT00251004
- Testing
- Everolimus, Mycophenolic Acid (MPA), Cyclosporine A (CsA)
- Where
- United States
- Volunteers
- 833 people
- Sponsor
- Novartis
Kidney Transplant Rejection
TruGraf® Testing in High-Risk Kidney Transplant Recipients
This is an observational study to evaluate TruGraf® testing in high immune risk kidney transplant recipients. TruGraf is the first and only non-invasive test approved by Medicare to rule out silent rejection in stable kidney…
- Trial name
- NCT04266613
- Testing
- TruGraf® Testing
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Transplant Genomics, Inc.
Graft Rejection, Kidney Failure
Study Of The Safety And Efficacy Of Conversion From A CNI To Sirolimus In Renally-Impaired Heart Transplant Recipients
The primary purpose of this study is to determine whether converting from calcineurin inhibitor (CNI) therapy to sirolimus therapy will be more effective than continuing calcineurin inhibitor therapy with respect to renal…
- Trial name
- NCT00369382
- Testing
- cyclosporine or tacrolimus, sirolimus
- Where
- 23 sites in United States, Australia and 5 more
- Volunteers
- 121 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
BK Virus Infection
A Safety, Pharmacokinetics and Efficacy Study of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients
This clinical research study will test the safety and efficacy of the investigational medication MAU868, compared to a placebo, in patients who have had a kidney transplant who have active BK virus.
- Trial name
- NCT04294472
- Testing
- MAU868
- Where
- 18 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- Vera Therapeutics, Inc.
Kidney Transplant Rejection
A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation
The purpose of this open-label, randomized, active-comparator-controlled study is to determine the efficacy and safety of frexalimab subcutaneous administrations up to 5 years compared to tacrolimus capsules in adults undergoing…
- Trial name
- FREXERA (NCT07412470)
- Testing
- Frexalimab, Tacrolimus, rabbit anti-thymocyte globulin
- Where
- 73 sites in United States, Argentina and 16 more
- Volunteers
- 526 people
- Sponsor
- Sanofi
Graft vs Host Disease, Kidney Transplantation
Study Evaluating Sirolimus (Rapamune™) in Solid Organ Transplant Recipients
To evaluate the safety of long-term administration of sirolimus oral solution for up to 5 additional years, or until the tablet formulation is commercially available (whichever occurs first) in solid organ transplant recipients…
- Trial name
- NCT00037531
- Testing
- Sirolimus (RAPAMUNE)
- Where
- 20 sites in United States, Canada
- Volunteers
- 769 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Kidney Transplantation
A Study Looking at Diabetes in Kidney Transplant Recipients Receiving Immunosuppressive Regimen With or Without Steroids
The purpose of this study is to focus on potential differences in the occurrence of new-onset Diabetes Mellitus (a glucose metabolism disorder) when two different regimens of immunosuppressive treatment are compared.
- Trial name
- ADVANCE (NCT01304836)
- Testing
- Advagraf, Mycophenolate Mofetil, Simulect
- Where
- 100 sites in Australia, Belgium and 22 more
- Volunteers
- 1,166 people
- Sponsor
- Astellas Pharma Inc
Kidney Transplantation
A Study to Assess Immune Response in Pediatric Kidney Transplant Recipients Treated With Daclizumab (Zenapax)
This study will assess whether daclizumab impairs the ability of children receiving a kidney transplant to elicit a primary immune response.
- Trial name
- NCT02576145
- Testing
- DT, Daclizumab, KLH
- Where
- 5 sites in United States
- Volunteers
- 11 people
- Sponsor
- Hoffmann-La Roche
Transplantation Infection
Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients
The purpose of this study was to allow the continuation of everolimus treatment in patients who have completed the core study (NCT00170885) and to collect long-term safety, tolerability, and efficacy data in a group of patients…
- Trial name
- EVEREST (NCT01276457)
- Testing
- Everolimus 0.25 and 0.75 mg tablets, Cyclosporine very low dose (150-300 ng/mL) microemulsion, Cyclosporine low dose (350-500 ng/mL) microemulsion
- Volunteers
- 223 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplantation
OPERA Study: A Study of Two Dosing Regimens of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients.
This study will compare the incidence of acute clinical or subclinical rejection between immunosuppression with CellCept at a starting dose of 3mg po daily with therapeutic drug monitoring and standard immunosuppression with…
- Trial name
- NCT02005562
- Testing
- mycophenolate mofetil, anti-IL-2R, methylprednisolone
- Where
- 24 sites in France
- Volunteers
- 252 people
- Sponsor
- Hoffmann-La Roche
Immunosuppression Management, Biomarkers / Blood
PIONEER Trial (Post-Transplant Application of TruGraf and TRAC Molecular Panel in Renal Transplant Recipients)
This is an observational, prospective, multi-center trial designed to evaluate clinical outcomes in kidney transplant recipients undergoing TruGraf and TRAC monitoring. Approximately 15 U.S. sites
- Conditions
- Immunosuppression Management, Biomarkers / Blood, Subclinical Rejection, Biopsy
- Trial name
- PIONEER (NCT07231328)
- Testing
- There is no required Intervention for this Protocol. Based on Results for TruGraf/TRAC/TRAC ID Investigators may use the results in managing subjects Immunosuppression or rule out rejection.
- Volunteers
- 600 people
- Sponsor
- Transplant Genomics, Inc.
Cytomegalovirus Infection, Cytomegalovirus Disease
MK-8228 (Letermovir) in the Prevention of Human Cytomegalovirus (CMV) Infection and Disease in Adult Japanese Kidney Transplant Recipients (MK-8228-042)
This study aims to evaluate the safety, efficacy and pharmacokinetics (PK) of Letermovir (LET) administered as prevention of cytomegalovirus (CMV) infection and disease in adult Japanese kidney transplant recipients.
- Trial name
- NCT04129398
- Testing
- Letermovir tablet, Letermovir IV
- Where
- 4 sites in Japan
- Volunteers
- 22 people
- Sponsor
- Merck Sharp & Dohme LLC