Clinical trials: Kidney Transplantation
Kidney Transplantation
A Study to Assess Pharmacokinetic, Pharmacodynamic, Safety and Tolerability of ASKP1240 in de Novo Kidney Transplantation
The purpose of the study is to assess the Pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of ASKP1240 when administered to subjects who received a de novo kidney transplant.
- Trial name
- NCT01279538
- Testing
- bleselumab
- Where
- 21 sites in United States
- Volunteers
- 50 people
- Sponsor
- Astellas Pharma Inc
The Rate of Kidney Transplants in Sensitized Patients.
Regional Kidney Paired Donor Exchange in Sensitized Patients
This is a prospective, multi-center, observational study to determine if a combination of desensitization and enrollment in a regional kidney paired donor (KPD) exchange program improves the overall rate of kidney transplantation…
- Trial name
- NCT01896089
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- BiologicTx, LLC
Kidney Transplantation
Evaluation of the Therapeutic Benefit of an Initial Intensified Dosing Regimen of Mycophenolate Sodium Versus a Standard Regimen in Renal Transplant Patients
The purpose of this study is to determine if an initial intensified enteric-coated mycophenolate sodium (Myfortic) dosing regimen administered during the first six weeks post renal transplantation provides improved efficacy, with…
- Trial name
- NCT00419926
- Testing
- Enteric-coated mycophenolate sodium (Myfortic), Cyclosporine (Neoral), Prednisone
- Where
- Switzerland
- Volunteers
- 313 people
- Sponsor
- Novartis
Herpes Zoster
A Study to Test GlaxoSmithKline's (GSK) Candidate Vaccine-GSK1437173A for Prevention of Shingles in Children With Kidney Transplant
The purpose of this study is to evaluate the reactogenicity, safety and immunogenicity of 2 doses of PED-HZ/su, GSK's vaccine candidate for the prevention of Herpes Zoster (HZ) in immunocompromised paediatric renal transplant…
- Trial name
- NCT04006808
- Testing
- PED-HZ/su
- Where
- 31 sites in Belgium, France and 4 more
- Volunteers
- 184 people
- Sponsor
- GlaxoSmithKline
Kidney Transplantation
Study To Evaluate the Status of Subjects That Discontinued Participation in a Qualifying Amgen Sponsored AMG 073 Study Due to Kidney Transplantation
The purpose of this study is to collect local laboratory data on immunoreactive parathyroid hormone (iPTH), calcium and phosphorus levels and estimated glomerular filtration rate (GFR) at approximately 1 week, 1 month, 3 months…
- Trial name
- NCT00110656
- Testing
- Observations
- Volunteers
- 38 people
- Sponsor
- Amgen
BK Virus Infection, Nephropathy
Study to Confirm of the Safety and Tolerability of Brincidofovir in Subjects With BK Virus Infection (Viremia) After Kidney Transplantation
This is a Phase II, multicenter, open-label, randomized, standard of care (SOC) controlled, multiple ascending dose study to assess the safety and tolerability of IV Brincidofovir (BCV) in subjects with BKV infection after kidney…
- Conditions
- BK Virus Infection, Nephropathy, Kidney Transplantation
- Trial name
- NCT05511779
- Testing
- Brincidofovir
- Where
- Japan
- Volunteers
- 1 people
- Sponsor
- SymBio Pharmaceuticals
Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Solid Organ Transplant Complications
A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy
The purpose of this study is to determine the clinical benefit and characterize the safety profile of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in the…
- Conditions
- Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Solid Organ Transplant Complications, Lymphoproliferative Disorders, Allogeneic Hematopoietic Cell Transplant
- Trial name
- ALLELE (NCT03394365)
- Testing
- tabelecleucel
- Where
- 71 sites in United States, Australia and 7 more
- Volunteers
- 115 people
- Sponsor
- Pierre Fabre Medicament
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
Liver Transplantation
RESCUE Study - Everolimus in Liver Transplantation Recipients With Renal Insufficiency
The purpose of the study is to assess the effect of everolimus initiation together with reduction or discontinuation of calcineurin inhibitor (CNI) on renal function in maintenance liver transplant recipients with CNI-related…
- Trial name
- NCT00267189
- Testing
- Everolimus, Calcineurin inhibitors (CNI), Mycophenolate acid (MPA)/ Azathioprine (AZA)
- Where
- 2 sites in Germany, Switzerland
- Volunteers
- 145 people
- Sponsor
- Novartis Pharmaceuticals
Renal Transplanted Recipients
SOCRATES: Steroid or Cyclosporine Removal After Transplantation Using Everolimus
The aim of this study is to assess the safety and efficacy of corticosteroid discontinuation versus cyclosporine micro emulsion discontinuation in recipients receiving reduced exposure cyclosporine micro emulsion and…
- Trial name
- NCT00371826
- Testing
- Everolimus (RAD001), Cyclosporine (Calcineurin Inhibitor (CNI)), Methylprednisone/prednisone
- Where
- 7 sites in Australia
- Volunteers
- 126 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplantation, Primary Focal Segmental Glomerulosclerosis (FSGS)
Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients
The purpose of this study was to assess the efficacy of the bleselumab regimen (basiliximab induction, tacrolimus, steroids and bleselumab) compared with the Standard of Care (SOC) regimen (basiliximab induction, tacrolimus…
- Trial name
- NCT02921789
- Testing
- Bleselumab, Basiliximab, Mycophenolate Mofetil (MMF)
- Where
- 23 sites in United States, Canada
- Volunteers
- 67 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Antibody Mediated Rejection
Safety & Efficacy of Eculizumab to Prevent AMR in Living Donor Kidney Transplant Recipients Requiring Desensitization
The purpose of this trial was to determine the safety and efficacy of eculizumab in the prevention of antibody-mediated rejection (AMR) in sensitized recipients of a living donor kidney transplant requiring desensitization…
- Trial name
- NCT01399593
- Testing
- Eculizumab
- Where
- 41 sites in United States, Australia and 8 more
- Volunteers
- 102 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Graft Rejection, Kidney Transplant
Study Evaluating A Planned Transition From Tacrolimus To Sirolimus In Kidney Transplant Recipients
This study will look at the effect on long-term kidney function using tacrolimus right after a transplant and then switching to sirolimus at 3 to 5 months after the transplant.
- Conditions
- Graft Rejection, Kidney Transplant, Renal Allograft Recipients, Renal Transplant
- Trial name
- NCT00895583
- Testing
- Tacrolimus, Sirolimus
- Where
- 44 sites in United States, Argentina and 5 more
- Volunteers
- 254 people
- Sponsor
- Pfizer
Kidney Transplantation
Study Investigating Rapamune For Post-Marketing Surveillance
To provide safety and effectiveness information for Rapamune during the post-marketing period as required by Korea Food and Drug Administration (KFDA) regulations in order to identify any potential drug related treatment factors…
- Trial name
- NCT00484094
- Testing
- sirolimus
- Where
- 11 sites in South Korea
- Volunteers
- 209 people
- Sponsor
- Pfizer
End Stage Renal Disease (ESRD), Chronic Kidney Disease (CKD)
Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM)
This is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating the graft function of everolimus and reduced CNI versus MPA and standard CNI in adult de novo renal transplant recipients.
- Conditions
- End Stage Renal Disease (ESRD), Chronic Kidney Disease (CKD), Hemodialysis, Renal Replacement Therapy
- Trial name
- TRANSFORM (NCT01950819)
- Testing
- Induction therapy, Corticosteroids, EVR+rCNI
- Where
- 184 sites in United States, Argentina and 40 more
- Volunteers
- 2,037 people
- Sponsor
- Novartis Pharmaceuticals
Delayed Graft Function
YSPSL for Prevention of Delayed Graft Function Part A
Selectins have been implicated in the pathogenesis of ischemia/reperfusion (I/R)-induced kidney injury and resultant DGF. PSGL-1 is a ligand for P-, E-, and L-selectin.
- Trial name
- NCT00298181
- Testing
- YSPSL
- Where
- 10 sites in United States
- Volunteers
- 15 people
- Sponsor
- Y's Therapeutics, Inc.
Kidney Transplantation, Heart Transplantation
A Study to Determine Pharmacokinetics of Children Receiving Modigraf (Tacrolimus Granules) Following Solid Organ Transplantation
The purpose of this study is to find out how much of Modigraf is absorbed and used in the body and how fast it leaves the body (Pharmacokinetics).
- Conditions
- Kidney Transplantation, Heart Transplantation, Liver Transplantation
- Trial name
- OPTION (NCT01371331)
- Testing
- Tacrolimus granules
- Where
- 10 sites in Belgium, France and 4 more
- Volunteers
- 52 people
- Sponsor
- Astellas Pharma Europe Ltd.
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
Renal Transplantation
Efficacy and Safety of Everolimus With Enteric-Coated Mycophenolate Sodium (EC-MPS) in a Cyclosporine Microemulsion-free Regimen Compared to Standard Therapy in de Novo Renal Transplant Patients
The purpose of this study is to assess whether a calcineurin inhibitor (CNI)-free regimen with enteric-coated mycophenolate sodium (EC-MPS) and everolimus is as safe and well-tolerated as the standard regimen containing…
- Trial name
- NCT00154310
- Testing
- Everolimus, Cyclosporine, Enteric-coated mycophenolate sodium
- Where
- 3 sites in Germany, Switzerland
- Volunteers
- 300 people
- Sponsor
- Novartis
Kidney Transplantation, Transplantation
Pre-transplant Assessment of Tacrolimus Blood Level Concentration, as a Predictor of Tacrolimus Dose Requirements After Kidney Transplantation
The purpose of this study is to evaluate two groups of kidney transplant recipients, to determine the proportion of patients that achieve therapeutic blood concentrations of tacrolimus by Day 3 after transplantation.
- Trial name
- NCT00297310
- Testing
- tacrolimus
- Volunteers
- 89 people
- Sponsor
- Janssen-Cilag Pty Ltd