Clinical trials: Transplantation, Kidney
Renal Transplantation
Extension Study of Enteric-coated Mycophenolate Sodium in Combination With Full Dose or Reduced Dose Cyclosporine Microemulsion in Patients With de Novo Kidney Transplants
This extension study is considered to allow patients being treated with EC-MPS to collect further information on the long-term safety of this drug.
- Trial name
- NCT00238940
- Testing
- Enteric-Coated Mycophenolate Sodium (EC-MPS)
- Volunteers
- 55 people
- Sponsor
- Novartis
KIDNEY TRANSPLANTATION
Comparison of Two Tacrolimus Based Immunosuppressive Regimens in Recipients Receiving Marginal Donor Kidneys
The purpose of this study is to explore the safety and efficacy of two different immunosuppressive regimens (sequential tacrolimus/mycophenolate mofetil [MMF] plus steroids versus tacrolimus plus MMF, following induction with…
- Trial name
- TIGRE (NCT00321113)
- Testing
- tacrolimus, mycophenolate mofetil, steroids
- Where
- 14 sites in Italy
- Volunteers
- 142 people
- Sponsor
- Astellas Pharma Inc
Cytomegalovirus Infections
A Study of Valcyte (Valganciclovir) CMV Prophylaxis After Renal Transplantation
This 2 arm study will compare the efficacy of 100 days of Valcyte (900mg po daily) prophylaxis with that of no prophylaxis, under the condition of pre-emptive therapy of active CMV infection, in CMV positive renal transplant…
- Trial name
- NCT00372229
- Testing
- Valganciclovir CMV Prophylaxis, Valganciclovir (Pre-emptive CMV Therapy), Ganciclovir
- Where
- 24 sites in Austria, Germany
- Volunteers
- 299 people
- Sponsor
- Hoffmann-La Roche
Focal Segmental Glomerulosclerosis
Post Approval Study for Treatment of Drug-resistant Adult and Pediatric Primary FSGS Using the LIPOSORBER® LA-15 System
This multicenter, prospective, single-arm clinical study will evaluate the probable benefit and safety of the LIPOSORBER® LA-15 System for the treatment of adult patients with nephrotic syndrome associated with primary focal…
- Trial name
- FSGSALLAGE (NCT04065438)
- Testing
- LIPOSORBER® LA-15
- Where
- 10 sites in United States
- Volunteers
- 35 people
- Sponsor
- Kaneka Medical America LLC
Delayed Graft Function, Other Complications of Kidney Transplant
Biomarkers of Aging as Predictors of Kidney Transplant Function
The primary purpose of this study is to measure the correlation between baseline expression of aging biomarkers, SenesceTest in blood of organ donor and renal graft function.
- Trial name
- NCT02335333
- Testing
- No treatment
- Where
- 2 sites in United States
- Volunteers
- 35 people
- Sponsor
- Sapere Bio
Chronic Kidney Disease (CKD)
An Observational Extension Study for Adult Patients Treated in Study R5459-RT-1944 Who Receive a Kidney Transplant
The main purpose of this study is to continue to see how vonsetamig works in the body and to monitor the outcomes after kidney transplant for participants previously treated in the R5459-RT-1944 study (NCT05092347).
- Trial name
- NCT05106387
- Testing
- Noninterventional
- Where
- 9 sites in United States
- Volunteers
- 20 people
- Sponsor
- Regeneron Pharmaceuticals
Graft Rejection, Kidney Transplantation
Recombinant Human C1 Inhibitor for the Treatment of Early Antibody-Mediated Rejection in Renal Transplantation
The purpose of this study will be to assess the safety, tolerability, and efficacy of rhC1INH in renal transplant recipients with biopsy-confirmed antibody-mediated rejection (AMR) within 30 days of renal transplantation.
- Trial name
- NCT01035593
- Testing
- plasmapheresis and IVIG, recombinant C1 inhibitor
- Where
- United States
- Sponsor
- Pharming Technologies B.V.
End Stage Renal Disease
Multicentre, Open Label, Randomized, Two-arm, Parallel-group Study to Assess Efficacy and Safety of ENVARSUS® Compared With Tacrolimus Used as Per Current Clinical Practice in the Initial Maintenance Setting in de Novo Kidney Transplant Patients
The purpose of the study is to compare tacrolimus dosing of the new Envarsus®-based immunosuppressive regimen with current clinical practice (Prograf or Advagraf) over 6 months following de novo renal transplantation in a…
- Trial name
- STEADY (NCT02432833)
- Testing
- ENVARSUS®, PROGRAF®, ADVAGRAF®
- Where
- Italy
- Volunteers
- 428 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Renal Transplantation
Efficacy and Safety of FTY720 Versus Mycophenolate Mofetil (MMF, Roche Brand) in de Novo Adult Renal Transplant Recipients
This study will evaluate the safety and efficacy of FTY720 versus mycophenolate mofetil (MMF, Roche brand) combined with cyclosporine and corticosteroids in patients receiving a kidney transplant.
- Trial name
- NCT00239863
- Testing
- FTY720
- Volunteers
- 684 people
- Sponsor
- Novartis Pharmaceuticals
Heart Transplantation
A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Heart Transplant Patients.
This study will investigate the efficacy and safety of CellCept (1.5-2g/day po), in combination with a standard care regimen of cyclosporine A (trough level 150-200ng/mL) and steroids, in patients receiving a heart transplant.
- Trial name
- NCT02091414
- Testing
- mycophenolate mofetil (MMF), cyclosporine A (CsA), corticosteroids
- Where
- 3 sites in China
- Volunteers
- 36 people
- Sponsor
- Hoffmann-La Roche
Renal Transplantation
A Study Designed to Compare the Tolerability of an Increased Dose of Enteric-coated Mycophenolate Acid (MPA) in Renal Transplant Patients Whose Dose of Mycophenolate Mofetil (MMF) Was Reduced Due to Gastrointestinal Symptoms
To determine if conversion to enteric coated MPA allows an escalated dose of mycophenolic acid (MPA) to be tolerated in patients experiencing gastrointestinal (GI) symptoms
- Trial name
- NCT00658333
- Testing
- Enteric-coated Mycophenolate Acid (EC-MPA), Mycophenolate Mofetil (MMF)
- Where
- 37 sites in United States
- Volunteers
- 30 people
- Sponsor
- Novartis Pharmaceuticals
Anemia
A Study Comparing Subcutaneous Mircera and Darbepoetin Alfa for Maintenance Treatment of Anemia in Kidney Transplant Recipients.
This two arm study will compare the efficacy and safety of subcutaneous Mircera versus darbepoetin alfa for the maintenance of hemoglobin levels in kidney transplant recipients with chronic renal anemia.
- Trial name
- NCT00605345
- Testing
- Darbepoetin alfa, methoxy polyethylene glycol-epoetin beta [Mircera]
- Where
- 21 sites in Spain
- Volunteers
- 71 people
- Sponsor
- Hoffmann-La Roche
De Novo Kidney Transplant
MYPROMS-ES02: Safety and Efficacy of Basiliximab, Cyclosporine Microemulsion and Enteric-coated Mycophenolate Sodium (EC-MPS) Versus EC-MPS and Steroid Therapy in Kidney Transplant Recipients Who Are Hepatitis C Positive
To prospectively evaluate in de novo kidney transplant recipients, hepatitis C positive, the clinical outcomes of an immunosuppressive regimen of EC-MPS free of steroids in comparison with a regimen of EC-MPS with standard…
- Trial name
- NCT00284921
- Testing
- Enteric-coated Mycophenolate sodium (EC-MPS)
- Volunteers
- 60 people
- Sponsor
- Novartis Pharmaceuticals
Liver Transplantation
A Study of CellCept (Mycophenolate Mofetil) Combined With Calcineurin Inhibitors in Liver Transplant Patients.
This 2 arm study will compare the efficacy and safety of switching to CellCept combined with different regimens of reduced calcineurin inhibitors (CNI) in patients with liver transplants.
- Trial name
- NCT00717314
- Testing
- Mycophenolate mofetil, CNI (50%), CNI (≥75%)
- Where
- 11 sites in China
- Volunteers
- 87 people
- Sponsor
- Hoffmann-La Roche
Kidney Transplantation
Immediate Conversion From Tacrolimus to Everolimus in Stable Maintenance Renal Transplant Recipients
The purpose of this study is to investigate safety and tolerability of an immediate conversion from Tacrolimus to everolimus in stable renal allograft recipients.
- Trial name
- HERMES (NCT01269684)
- Testing
- Everolimus
- Where
- Switzerland
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplantation
Study Evaluating the Efficacy and Safety of Cyclosporine Reduction in Kidney Transplant Recipients Receiving Sirolimus
To evaluate the safety and efficacy of different doses of cyclosporine given concomitantly with a fixed dose of sirolimus in kidney transplant recipients.
- Trial name
- NCT00507793
- Testing
- Sirolimus, Cyclosporine
- Volunteers
- 385 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Kidney Failure
Induction of Donor Specific Tolerance in Recipients of Living Kidney Allografts by Donor FCRx Infusion
An open-label study to assess the safety, efficacy, and tolerance of FCRx cell therapy in adult recipients within 12 months after kidney transplantation from a living donor.
- Trial name
- NCT00497926
- Testing
- Enriched Hematopoietic Stem Cell Infusion
- Where
- 2 sites in United States
- Volunteers
- 37 people
- Sponsor
- Talaris Therapeutics Inc.
Renal Transplantation
This is a Two-year Follow-up Study to Evaluate the Long-term Safety, Tolerability and Efficacy of 2 Different Doses of Everolimus
This extension study is designed to provide long-term safety and efficacy data beyond 12 months up to Month 36.
- Trial name
- NCT00531063
- Testing
- Everolimus (RAD001)
- Where
- Switzerland
- Volunteers
- 237 people
- Sponsor
- Novartis Pharmaceuticals
End Stage Renal Disease, Renal Transplant
Evaluating Safety and Efficacy of TOL101 Induction Versus Anti-Thymocyte Globulin to Prevent Kidney Transplant Rejection
Induction therapy with antibodies is administered during transplant surgery and for a short period of time following transplant surgery in an effort to render the immune system less able to mount an initial rejection response.
- Trial name
- NCT01154387
- Testing
- Anti-Thymocyte Globulin, TOL101, Steroids
- Where
- 12 sites in United States
- Volunteers
- 85 people
- Sponsor
- Tolera Therapeutics, Inc
Kidney Transplant
Study to Evaluate the Pharmacokinetics and Tolerability of Tacrolimus in Kidney Transplant Recipients.
The purpose of this study is to evaluate the pharmacokinetics and tolerability of Tacrolimus tablet(TacroBell) in kidney transplant recipients.
- Trial name
- PK-TACT (NCT04102943)
- Testing
- tacrolimus tablet, tacrolimus capsules
- Where
- South Korea
- Volunteers
- 128 people
- Sponsor
- Chong Kun Dang Pharmaceutical