Clinical trials: Transplantation, Kidney
Kidney Transplantation (Status Post)
Efficacy, Safety, Tolerability and Pharmacokinetic (PK) Study of GSK1070806 for the Prevention of Delayed Graft Function (DGF) in Adult Subjects After Renal Transplantation
This is a phase 2 study to evaluate the efficacy, safety, tolerability and pharmacokinetics of GSK1070806 in subjects undergoing renal transplantation.
- Trial name
- NCT02723786
- Testing
- GSK1070806, 1) basiliximab 2) mycophenolate mofetil (MMF) OR azathioprine 3) tacrolimus 4) corticosteroids
- Where
- 4 sites in Spain, United Kingdom
- Volunteers
- 7 people
- Sponsor
- GlaxoSmithKline
Renal Transplant Recipients With Anti-HLA Antibodies
A Prospective, Global, Multi-center, Treatment Registry Study of Intravenous Immunoglobulin Maintenance Therapy in Alloantibody Positive Renal Allograft Recipients
The purpose of this treatment registry study is to determine if monthly infusions of Intravenous Immunoglobulin (IVIg) for 6 months will neutralize donor specific antibodies that are thought to be responsible for chronic…
- Trial name
- DSA (NCT02115503)
- Where
- 8 sites in United States
- Volunteers
- 52 people
- Sponsor
- Databean
Kidney Transplantation
Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients
The purpose of this study is to compare the safety and efficacy of different induction agents (alemtuzumab, basiliximab or rabbit anti-thymocyte globulin) in renal transplant recipients treated with tacrolimus, mycophenolate…
- Trial name
- INTAC (NCT00113269)
- Testing
- basiliximab, rabbit anti-thymocyte globulin, tacrolimus
- Where
- 29 sites in United States
- Volunteers
- 501 people
- Sponsor
- Astellas Pharma Inc
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, Liver Transplantation
A Study to Compare the Finger Prick Whole Blood MITRA Assay Method With the Established Venepuncture Whole Blood Method for Quantitative Determination of Tacrolimus Blood Concentrations in Transplant Patients
The purpose of this study is to assess relationship between tacrolimus concentrations determined via whole blood MITRA assay method with those determined using the established and validated whole blood venepuncture method using…
- Trial name
- MITRA (NCT03465969)
- Testing
- tacrolimus
- Where
- 4 sites in France, United Kingdom
- Volunteers
- 80 people
- Sponsor
- Astellas Pharma Europe Ltd.
Kidney Transplant
Non-inferiority Study of Safety and Efficacy of Everolimus With Low Dose Tacrolimus to Mycophenolate Mofetil With Standard Dose Tacrolimus in Kidney Transplant Recipients
The purpose of this phase 3b study is to compare the safety and efficacy of everolimus with low dose tacrolimus to mycophenolate mofetil with standard dose tacrolimus in kidney transplant recipients.
- Trial name
- NCT01025817
- Testing
- Everolimus and tacrolimus, mycophenolate mofetil and tacrolimus
- Where
- 50 sites in United States, Canada
- Volunteers
- 613 people
- Sponsor
- Novartis Pharmaceuticals
Renal Transplantation, Kidney Transplantation
A Single Center, Open-label, Randomized, Pilot Study to Evaluate the Safety and Efficacy of a Tacrolimus Modified Release, ADVAGRAF®, Versus Tacrolimus Twice Daily, PROGRAF® in Stable Renal Recipients
The purpose of this study is to evaluate and compare the safety and efficacy of two drugs (ADVAGRAF® and PROGRAF® groups) in patients who received renal transplantation.
- Conditions
- Renal Transplantation, Kidney Transplantation, Stable Renal Recipients
- Trial name
- SINGLE (NCT01742676)
- Testing
- ADVAGRAF, PROGRAF
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Astellas Pharma Korea, Inc.
Renal Transplantation
A Belatacept Compassionate Use Study for Patients With a Kidney Transplant
To make belatacept available for recipients of a renal allograft who are currently intolerant to or have contraindications to CNIs and/or m-TOR inhibitors and are either: unable to construct an adequate immunosuppression regimen…
- Trial name
- NCT00719225
- Testing
- Belatacept
- Where
- 7 sites in United States
- Sponsor
- Bristol-Myers Squibb
Renal Transplantation
Efficacy, Safety, Tolerability, and Pharmacokinetics of Sotrastaurin Combined With Tacrolimus vs. a Mycophenolic Acid-tacrolimus Regimen in Renal Transplant Patients
This study will assess the safety and efficacy of different doses of sotrastaurin when combined with tacrolimus for the prevention of acute rejection after de novo renal transplantation.
- Trial name
- NCT01064791
- Testing
- sotrastaurin (Dose 1) + tacrolimus + standard of care medications, sotrastaurin (Dose 2) + tacrolimus + standard of care medications, sotrastaurin (Dose 3) + tacrolimus + standard of care medications
- Where
- 44 sites in United States, Argentina and 13 more
- Volunteers
- 298 people
- Sponsor
- Novartis Pharmaceuticals
Renal Failure, Tremors
Switching Study of Kidney Transplant Patients With Tremor to LCP-Tacro (STRATO)
This study will evaluate and measure symptomatic hand tremor in stable kidney transplant subjects on Prograf or generic tacrolimus maintenance therapy at baseline (pre-conversion) and following conversion to LCP-Tacro.
- Trial name
- STRATO (NCT01438710)
- Testing
- Prograf, LCP-Tacro
- Where
- 10 sites in United States
- Volunteers
- 44 people
- Sponsor
- Veloxis Pharmaceuticals
Prevention of Acute Rejection in Paediatric Recipients of a Renal Transplant
Efficacy, Tolerability and Safety of Early Introduction of Everolimus, Reduced Calcineurin Inhibitors and Early Steroid Elimination Compared to Standard CNI, Mycophenolate Mofetil and Steroid Regimen in Paediatric Renal Transplant Recipients
The purpose of this study is to determine if everolimus combined with reduced exposure CNI (TAC) is efficacious and safe and will support corticosteroid elimination compared to a standard exposure CNI (TAC) + MMF + steroid…
- Trial name
- NCT01544491
- Testing
- RAD001, MMF
- Where
- 31 sites in United States, Argentina and 11 more
- Volunteers
- 106 people
- Sponsor
- Novartis Pharmaceuticals
Actinic Keratosis
Gene Expression in Renal Transplant Patients With Field Actinic Keratosis Undergoing Metvix® Photodynamic Therapy (PDT)
The aim of this study is to determine possible molecular changes on large scale gene expression profiling after treatment with Metvix photodynamic therapy (PDT) of actinic keratoses (AK) and cancerised field in renal transplant…
- Trial name
- NCT01000636
- Testing
- Metvix PDT
- Where
- United Kingdom
- Volunteers
- 9 people
- Sponsor
- Galderma R&D
Liver Dysfunction, Rejection, Transplant
Evaluation of Thymoglobulin Induction and Reduced Doses of Calcineurin Inhibitors on Liver Transplant Rejection
This study involves the use of a drug called Thymoglobulin, which is approved in the US to treat kidney transplant rejection and in Canada to treat and prevent kidney transplant rejection.
- Conditions
- Liver Dysfunction, Rejection, Transplant, Transplantation, Liver
- Trial name
- NCT00117689
- Testing
- Thymoglobulin, Corticosteroid, Tacrolimus
- Where
- 16 sites in United States, Canada
- Volunteers
- 75 people
- Sponsor
- Genzyme, a Sanofi Company
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
Anemia
A Study of Subcutaneous Mircera, Versus no Erythropoiesis-Stimulating Agent (ESA) Therapy, in the Treatment of Anemia in Patients With Chronic Kidney Disease After Kidney Transplant
This 2 arm study will assess the efficacy, safety and tolerability of subcutaneous Mircera, versus no ESA therapy, in chronic kidney disease patients with anemia after kidney transplant, not currently treated with ESA.
- Trial name
- NCT00576602
- Testing
- methoxy polyethylene glycol-epoetin beta [Mircera], Supportive treatment
- Where
- 20 sites in Belgium, France and 4 more
- Volunteers
- 1 people
- Sponsor
- Hoffmann-La Roche
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 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
Renal Failure
Pharmacokinetics of LCP-Tacro in Stable Kidney Transplant Patients
A three sequence, open-label, multi-center, prospective, study in stable kidney transplant patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of LCP-Tacro (tacrolimus) tablets versus Prograf…
- Trial name
- NCT00496483
- Testing
- LCP Tacro (tacrolimus), Prograf
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Veloxis Pharmaceuticals
Kidney Transplant
Pharmacokinetics, Safety and Tolerability of Single-dose Belatacept in Adolescent Kidney Transplant Recipients
The purpose of this study is to evaluate how well adolescent kidney transplant patients tolerate a single dose of belatacept they receive at least 6 months after transplant surgery, and how their body handles the drug.
- Trial name
- NCT01791491
- Testing
- Belatacept
- Where
- 8 sites in United States
- Volunteers
- 16 people
- Sponsor
- Bristol-Myers Squibb
Heart Transplantation
A Study of Daclizumab (Zenapax) in Combination With Mycophenolate Mofetil (CellCept) and Sirolimus in Prevention of Acute Rejection in Heart Transplant Participants
This study will evaluate the efficacy and safety of intravenous daclizumab in combination with oral mycophenolate mofetil and oral sirolimus in participants receiving a heart transplant, and at risk of impaired kidney function.
- Trial name
- NCT02554955
- Testing
- Daclizumab, Mycophenolate mofetil, Silrolimus
- Where
- 14 sites in Spain
- Volunteers
- 36 people
- Sponsor
- Hoffmann-La Roche