Clinical trials: Immunosuppression After Kidney Transplantation
EBV Infection, EBV Viremia
EVITA Study - Epstein-Barr Virus Infection moniToring in renAl Transplant Recipients
Transplant recipients are treated with immunosuppressive drugs to avoid rejection of the transplanted organ. As the medication impairs the immune response, it also increases the risk of serious infections and cancer in transplant…
- Conditions
- EBV Infection, EBV Viremia, Epstein-Barr Virus Associated Lymphoproliferative Disorder, Post-transplant Lymphoproliferative Disorder
- Trial name
- EVITA (NCT04189835)
- Testing
- EBV DNA in whole blood and plasma
- Where
- 3 sites in Denmark, Norway
- Volunteers
- 509 people
- Sponsor
- University of Aarhus
Heart Transplantation, Renal Failure
Rapamycin Use in Calcineurin Inhibitor (CNI)-Free Immunosuppression for Stabilization/Improvement of Renal Function After Heart Transplantation
Clinical Problem: Renal insufficiency after heart transplantation caused by cyclosporine medication was addressed. Current therapeutic approaches include cyclosporine reduction or discontinuation.
- Trial name
- NCT00123331
- Testing
- Cyclosporine discontinuation, Rapamycin medication
- Where
- Germany
- Volunteers
- 40 people
- Sponsor
- Heidelberg University
Kidney Transplantation, Ischemia-Reperfusion Injury
Thymoglobulin Induction in Kidney Transplant Recipients
The purpose of this study is to determine if anti-thymocyte globulin (Thymoglobuline) administration in the kidney transplant recipient is able to reduce the amount of damage that kidneys transplanted from deceased donors…
- Trial name
- TIKT (NCT01239563)
- Testing
- antithymocyte globulin, Basiliximab
- Where
- 2 sites in United Kingdom
- Volunteers
- 40 people
- Sponsor
- University of Oxford
Recipients of Liver Transplant
Envarsus XL Immunosuppression Following Liver Transplantation
The standard immunosuppressive regimen for liver transplantation includes twice daily tacrolimus (Prograf). In other transplantation models, there are potential benefits to extended release formulations as lower peak…
- Trial name
- NCT03828058
- Testing
- Envarsus XR, Prograf
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Methodist Healthcare - Memphis
Liver Transplantation
Biomarkers Predicting Successful Tacrolimus Withdrawal and Everolimus (Zortress) Monotherapy Early After Liver Transplantation
Most patients who get a liver transplant must take immunosuppressants for the rest of their lives. However, this has occurred at the expense of chronic CNI toxicity, e.g.
- Trial name
- NCT02736227
- Testing
- Tacrolimus Withdrawal and Everolimus Monotherapy
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Northwestern University
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 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
Disorder Related to Renal Transplantation, Renal Transplant Rejection
Testing Immunosuppression Threshold in Renal Allografts To Extend eGFR
This study evaluates the addition of "Kidney Solid Organ Rejection Test" (kSORT), in the clinical follow-up of renal transplant recipients, compared to clinical standard surveillance in the first two years after kidney…
- Conditions
- Disorder Related to Renal Transplantation, Renal Transplant Rejection, Acute Graft Rejection
- Trial name
- TITRATE (NCT02581436)
- Testing
- kSORT assay based follow-up, Standard follow-up
- Where
- Mexico
- Volunteers
- 70 people
- Sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Chronic Renal Disease
Once-a-day Immunosuppression(CISECON_a_day)
The objective of this study is to assess the efficacy and safety and Immunosuppressant Therapy Barrier Scale (ITBS) of once daily immunosuppressant maintenance therapy in patients who had kidney transplantations earlier.
- Trial name
- CISECON (NCT01964014)
- Testing
- advagrf
- Where
- 7 sites in South Korea
- Volunteers
- 160 people
- Sponsor
- Ajou University School of Medicine
SARS-CoV-2 Infection, Active Immunization
Saxon SARS-CoV-2 Infection and Vaccination Study in Dialysis Patients, Solid Organ Recipients and Staff
To investigate short- (3 and 8 weeks) and long-term (6, 9, 12, and 18 months) immune protection or response at the humoral and cellular levels before and after SARS-CoV-2 infection or vaccination in patients with moderately…
- Conditions
- SARS-CoV-2 Infection, Active Immunization, Immune Response, Immunosuppression
- Trial name
- DIA-Vacc (NCT04799808)
- Where
- Germany
- Volunteers
- 3,500 people, healthy volunteers welcome
- Sponsor
- Technische Universität Dresden
Kidney Transplant Failure, Allosensitization
Extended Release Versus Immediate Release Tacrolimus Following Renal Allograft Failure to Reduce Allosensitisation
Study to compare once-daily extended release tacrolimus versus twice-daily immediate release tacrolimus following renal allograft failure to reduce the risk of allosensitisation
- Conditions
- Kidney Transplant Failure, Allosensitization, Immunosuppression
- Trial name
- EVITRA (NCT03689075)
- Testing
- Envarsus Oral Product
- Where
- United Kingdom
- Volunteers
- 35 people
- Sponsor
- Imperial College Healthcare NHS Trust
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.
Kidney Transplantation, Chronic Kidney Disease
Calcineurin Free Immunosuppression in Renal Transplant Recipients
The main purpose of this study is to obtain preliminary information on the efficacy, safety and cost of two regimens, Rapamycin / MMF / steroid therapy and Cyclosporine A Neoral / MMF / steroid therapy, used in the prevention of…
- Trial name
- NCT00812123
- Testing
- Sirolimus, Cyclosporine A, Prednisone
- Where
- Switzerland
- Volunteers
- 127 people
- Sponsor
- University Hospital, Basel, Switzerland
End-stage Renal Disease (ESRD), Kidney Transplantation
Microbiota Changes Related to Outcomes in Kidney Transplantation
Chronic kidney disease affects approximately 10% of the world population. End-stage renal disease (ESRD) is associated with immune dysregulation, chronic inflammation, and alteration of the gut and urinary microbiota.
- Trial name
- MICRO-KT (NCT07893691)
- Testing
- Fecal samples, Urinary sample, Blood samples
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Hospices Civils de Lyon
Kidney Transplantation
BMT and High Dose Post-Transplant Cyclophosphamide for Chimerism Induction and Renal Allograft Tolerance
The primary objective of this study is to assess the ability of bone marrow transplantation (BMT) and high-dose post-transplantation cyclophosphamide (PT/Cy) to induce renal allograft tolerance and thus enable discontinuation of…
- Trial name
- NCT02029638
- Testing
- anti-thymocyte globulin, Fludarabine, Cyclophosphamide
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Kidney Transplantation
Bela 8 Week Dosing
The purpose of this study is to transition patients who have been stable on Belatacept for one year after kidney transplant from standard 4-week to an investigational 8-week belatacept dosing schedule.
- Trial name
- NCT02560558
- Testing
- Belatacept
- Where
- 2 sites in United States
- Volunteers
- 166 people
- Sponsor
- Emory University
Kidney Function After Transplantation, Outcome After Kidney Transplantation
Sirolimus Based Immunosuppression for Patients Undergoing Kidney Transplantation in the Eurotransplant Senior Program
The Eurotransplant Senior Program (ESP) started in 1999 with local allocation of kidneys from deceased donors elder than 65 years to recipients elder than 65 years.
- Trial name
- ESP (NCT00461357)
- Volunteers
- 48 people
- Sponsor
- Medical University of Vienna
Terminal Renal Failure, BK Virus Infection
BK Viremia After Renal Transplantation
Hypothesis: Early detection, and treatment, of BK virus infection after kidney transplantation will prevent BK virus associated kidney transplant injury.
- Trial name
- NCT00684372
- Testing
- leflunomide
- Where
- Sweden
- Volunteers
- 100 people
- Sponsor
- Karolinska University Hospital
Antibody-mediated Rejection
DSA Risk Factors in MMF-based Immunosuppressed Post-transplanted Patients
Kidney transplantation is the best therapy method for patients with uremia. The main factors affecting the long-term survival of the graft were chronic antibody-mediated rejection and the death of the patients.
- Trial name
- DRFMBIPTP (NCT04368962)
- Where
- China
- Volunteers
- 300 people
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University
Acute Cellular Graft Rejection, Liver Transplant Rejection
Budesonide for Immunosuppression After Liver Transplantation to Reduce Side Effects
Our hypothesis is that budesonide will provide effective hepatic ISP that will replace prednisone and allow lower systemic drug levels of FK, thus reducing the steroid- and calcineurin-associated complications often observed in…
- Trial name
- BILT (NCT03315052)
- Testing
- Budesonide, Tacrolimus（FK506）, Mycophenolate Mofetil
- Sponsor
- Montefiore Medical Center