Clinical trials: Kidney Transplant Immunosuppression
Liver Transplantation
Phase 3b Study to Evaluate Advagraf in Combination With Mycophenolate Mofetil and Basiliximab in Liver Transplantation
Comparison of 3 dosing regimens of Advagraf to determine if there is a dosing regimen which may have the potential to cause fewer kidney problems.
- Trial name
- DIAMOND (NCT01011205)
- Testing
- Advagraf, Mycophenolate Mofetil, Basiliximab
- Where
- 72 sites in Argentina, Austria and 21 more
- Volunteers
- 893 people
- Sponsor
- Astellas Pharma Inc
Kidney Transplant, Immunosuppression
Evaluation of Interaction Between Immunosuppressive Drugs and Protein-bound Uremic Toxins in Renal Transplant Patients
The majority of studies conducted on uremic toxins involve patients before end stage renal failure or dialysis patients. Only a few studies have focused on transplant patients.
- Conditions
- Kidney Transplant, Immunosuppression, Uremic; Toxemia
- Trial name
- DRUGTOX (NCT04963673)
- Testing
- calcineurin inhibitor dosage
- Where
- France
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Kidney Transplantation
A Study in Kidney Transplant Subjects to Investigate the Optimal Suppression of Immunity to Help Prevent Kidney Rejection
To compare how well the new formulation of Tacrolimus® used once daily, in combination with other drugs helps prevent the rejection of a new kidney after transplantation compared to the twice daily dose of Tacrolimus
- Trial name
- OSAKA (NCT00717470)
- Testing
- Prograf®, Advagraf®, Mycophenolate Mofetil
- Where
- 110 sites in Argentina, Austria and 20 more
- Volunteers
- 1,252 people
- Sponsor
- Astellas Pharma Inc
Immunosuppression
Dosing Requirements of Astagraf XL® in African American Kidney Transplant Recipients
Compare the difference in dose-normalized trough and total daily dose necessary to reach the steady state therapeutic goal after conversion from tacrolimus IR to Astagraf XL® in African American kidney transplant recipients.
- Trial name
- NCT02953873
- Testing
- Tacrolimus Extended Release Capsule, Mycophenolate mofetil, Prednisone
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Medical University of South Carolina
Kidney Diseases, Graft Rejection
Renal Function Optimization With Mycophenolate Mofetil (MMF) Immunosuppressor Regimes (ALHAMBRA)
The main aim of this study is to compare the renal function (serum creatinine at 6 months) in the later introduction of tacrolimus or rapamycin based in immunosuppressor regimes with daclizumab, mycophenolate mofetil, and…
- Trial name
- NCT00290069
- Testing
- Tacrolimus, Rapamycin
- Where
- 7 sites in Spain
- Volunteers
- 94 people
- Sponsor
- Sociedad Andaluza de Trasplantes de Organos y Tejidos
Kidney Transplant Failure and Rejection
Comparison of the Cognitive and Motor Effects of Treatment Between an Immediate- and Extended-release Tacrolimus (Envarsus® XR) Based Immunosuppression Regimen in Kidney Transplant Recipients
The primary objective is to compare the effect of treatment with an immediate-release tacrolimus to an extended-release tacrolimus (i.e., Envarsus® XR) immunosuppressive regimen on cognitive and motor function in kidney…
- Trial name
- NCT03437577
- Testing
- immediate-release tacrolimus, extended release tacrolimus
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- University of Minnesota
Covid19
PROphylaxis for paTiEnts at Risk of COVID-19 infecTion -V
COVID-19 (SARS-CoV2 virus) was declared a global pandemic by the WHO on 11th March 2020. Currently there are no drugs proven to prevent COVID-19 or to reduce the severity of illness if given as prophylaxis.
- Trial name
- PROTECT-V (NCT04870333)
- Testing
- Niclosamide, Ciclesonide, Sotrovimab
- Where
- 45 sites in United Kingdom
- Volunteers
- 2,240 people
- Sponsor
- Cambridge University Hospitals NHS Foundation Trust
Aspergillosis
Surveillance of Fungal Infections During Construction Activity
Fungal infections in immunocompromised patients occuring during construction activities in hospitals have repeatedly been reported.
- Trial name
- NCT00473252
- Where
- Switzerland
- Volunteers
- 340 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Kidney Transplant; Complications
Once Daily Immunosuppression Regimen
The purpose of this research study is to determine whether an immunosuppressive maintenance regimen of Envarsus/azathioprine compared to a tacrolimus/ mycophenolic acid regimen is associated with better compliance, tolerability…
- Trial name
- NCT03555448
- Testing
- Once daily immunosuppression regimen, Twice daily immunosuppression regimen
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Washington University School of Medicine
Kidney Transplant Rejection
CLinical Utility of the omnigrAf® biomarkeR Panel In The Care of kidneY Transplant Recipients
This is a prospective, multi-site, observational study with a matched control group. The primary objective is to evaluate change in renal function over time in recipients of kidney transplants who are undergoing OmniGrafTM…
- Trial name
- CLARITY (NCT05482100)
- Testing
- Patients monitored with OmniGraf testing
- Volunteers
- 500 people
- Sponsor
- Transplant Genomics, Inc.
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
Effects of the Quadruple Immunosuppression on Peripheral Blood Lymphocytes and Development of Anti-HLA Antibodies in Kidney Transplant
The purpose of this study is to determine the effects of sirolimus in the phenotype of peripheral blood T and B lymphocytes regarding their naïve, memory, effector end regulatory phenotype and in the development of anti-HLA…
- Trial name
- NCT02208791
- Testing
- Sirolimus, No intervention
- Where
- Brazil
- Volunteers
- 45 people
- Sponsor
- University of Sao Paulo General Hospital
Kidney Transplantation
Efficacy and Safety of FTY720 in Patients Who Receive a Kidney Transplant
The efficacy and safety of FTY720 is being evaluated in patients who receive a kidney transplant.
- Trial name
- NCT00099736
- Testing
- FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids, FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids, MMF 2 g + full-dose Neoral (FDN) + corticosteroids
- Where
- 42 sites in United States
- Volunteers
- 696 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplant Failure and Rejection
BIOtechnology Applied to Renal TRansplantation With IMmunobiogram
Immunobiogram (IMBG) is a novel in vitro diagnostic bioassay developed by Biohope Scientific Solutions for Human Health SL, that allows to measure the pharmacodynamic response to individual immunosuppressive drugs in patients…
- Trial name
- BIOTRAIM (NCT05816486)
- Testing
- Immunobiogram
- Where
- 15 sites in Brazil, France and 3 more
- Volunteers
- 443 people
- Sponsor
- Biohope Scientific Solutions for Human Health, S.L.
Renal-urinary Impairment, Graft Rejection
Study of the Pathogenicity and Humoral Immune Response Induced by BK Virus in Lung Transplant Recipients
BK virus (BKV) is a ubiquitous virus that infects more than 80% of the population. In case of immunosuppression, BKV can replicate and induce nephropathies in renal transplant recipients or haemorrhagic cystitis in bone marrow…
- Conditions
- Renal-urinary Impairment, Graft Rejection, Infection Episodes
- Trial name
- BKV-Pneumo (NCT04164576)
- Testing
- Transplant patients
- Where
- France
- Volunteers
- 120 people
- Sponsor
- University Hospital, Strasbourg, France
Kidney Transplantation
Efficacy and Safety of Sirolimus in Combination With Tacrolimus
To study the efficacy and safety of the administration of Tacrolimus in combination with Sirolimus for the prevention of acute rejection in patients after renal transplantation
- Trial name
- NCT00141804
- Testing
- Sirolimus
- Where
- Germany
- Volunteers
- 190 people
- Sponsor
- University Hospital Muenster
Kidney Transplantation
Maintenance Neoral Monotherapy Compared to Bitherapy in Renal Transplantation
We have previously defined factors that predict the long term success of maintenance CsA monotherapy (CsAm) after kidney transplantation : donor age < 40 years, serum creatinine level at the initiation of CsAm £ 125 µmol/L, no…
- Trial name
- NCT00461825
- Testing
- Cyclosporin A: C0: 75-125ng/ml-dose adapted in the 3 groups, Group A: CsA + Azathioprine(1 to 2 mg/kg/day), Group B: CsA + CellCept(500 mg x 2/day)
- Where
- 5 sites in France
- Volunteers
- 207 people
- Sponsor
- Poitiers University Hospital
Kidney Transplant Rejection, Kidney Transplant
Microbiome and Immunosuppression: The Mission Study
The purpose of this research is to study immunosuppression drugs, certain foods, and how they can change the microbiome (the natural microorganisms inside the body) of the individual taking the immunosuppressive medications.
- Trial name
- MISSION (NCT04953715)
- Testing
- collection of body microbiome
- Where
- 2 sites in United States
- Volunteers
- 140 people
- Sponsor
- The University of Texas Medical Branch, Galveston
Kidney Transplantation, Immunosuppression
Veloxis de Novo Kidney Transplant ECSWD
This study is designed to evaluate the safety and efficacy of LCPT in combination with rATG, mycophenolate and early corticosteroid withdrawal (CSWD) in de novo kidney transplant recipients.
- Trial name
- NCT03828682
- Testing
- Tacrolimus Extended Release Oral Tablet [Envarsus], Mycophenolate Mofetil, Mycophenolic Acid Oral Product
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Simon Tremblay, PharmD, PhD
Kidney Transplantation, Kidney Failure, Chronic
Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation
To compare the efficacy and safety of Tacrolimus in combination with MMF and Steroids in two regimens of steroid in an adult kidney transplanted population.
- Conditions
- Kidney Transplantation, Kidney Failure, Chronic, Renal Insufficiency, Chronic
- Trial name
- NCT00717379
- Testing
- Tacrolimus, Mycophenolate Mofetil, Methylprednisolone or equivalent
- Where
- 6 sites in Russia
- Volunteers
- 50 people
- Sponsor
- Astellas Pharma Inc