Clinical trials: Renal Transplant Recipient
Renal Interstitial Fibrosis
Progression of Renal Interstitial Fibrosis / Tubular Atrophy (IF/TA) According to Epithelial-mesenchymal Transition (EMT) and Immunosuppressive Regimen (Everolimus Based Versus CNI Based) in de Novo Renal Transplant Recipients
Recently, early biomarkers of renal interstitial fibrosis have been identified, amongst them de novo expression of vimentin by tubular epithelial cells, which is an intermediate filament, and the translocation of beta-catenin…
- Trial name
- CERTITEM (NCT01079143)
- Testing
- Certican®, Neoral, Myfortic
- Where
- 23 sites in France
- Volunteers
- 194 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplantation
Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients
The purpose of the study in de novo renal transplant patients is to evaluate the effect on renal function of an optimized new regimen in comparison with the standard everolimus exposure plus a low-dose cyclosporine microemulsion…
- Trial name
- NCT00170885
- Testing
- Everolimus
- Where
- Switzerland
- Sponsor
- Novartis
Kidney Transplantation
Efficacy and Safety of AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months), in Renal Transplant Patients
This study will evaluate the efficacy and safety of AEB071 in preventing acute rejections after kidney transplantation, when combined with tacrolimus for the first 3 months and with myfortic thereafter.
- Trial name
- NCT00403416
- Testing
- AEB071, Mycophenolic Acid
- Where
- 28 sites in United States, Canada and 6 more
- Volunteers
- 215 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplantation
A One-year, Open Label Study to Investigate the Safety and the Effect of Enteric-coated Mycophenolate Sodium (EC-MPS) in Combination With Cyclosporine Microemulsion in de Novo Kidney Transplant Recipients.
The study is a one-year prospective, open-label, safety and efficacy study. De novo renal transplant recipients will be receiving cyclosporine, 1.44g EC-MPS (720 mg b.i.d.), and corticosteroids .The study will consist of a…
- Trial name
- NCT00154245
- Testing
- Enteric-Coated Mycophenolate sodium (EC-MPS)
- Volunteers
- 20 people
- Sponsor
- Novartis
Cytomegalovirus Disease, Kidney Transplant Infection
A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus
This was a randomized, double-blind, double-dummy, parallel-group, multicenter study of the efficacy, safety, and tolerability of oral brincidofovir (BCV) versus valganciclovir for the prevention of cytomegalovirus (CMV) disease…
- Trial name
- NCT02439957
- Testing
- Brincidofovir, Valganciclovir
- Where
- 3 sites in United States
- Volunteers
- 6 people
- Sponsor
- Jazz Pharmaceuticals
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
Antibody-Mediated Rejection (AMR)
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-mediated rejection (AMR) is a major cause of worsening kidney function after a kidney transplant (kidney allograft dysfunction) and can lead to kidney failure.
- Trial name
- NCT07613359
- Testing
- Mezagitamab
- Where
- 35 sites in United States, China and 3 more
- Volunteers
- 36 people
- Sponsor
- Takeda
Cytomegalovirus Infections
A Study on Spermatogenesis in Male Renal Transplant Recipients Receiving Valganciclovir (Valcyte®) Versus Untreated Matched Controls
This observational study will compare spermatogenesis in male adult renal transplant recipients receiving valganciclovir versus untreated matched controls.
- Trial name
- NCT01663740
- Testing
- Valganciclovir
- Where
- 19 sites in United States, Mexico
- Volunteers
- 59 people
- Sponsor
- Hoffmann-La Roche
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.
Renal Transplantation
Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients
This study will evaluate the safety and efficacy of FTY720 combined with cyclosporine and corticosteroids in patients receiving a kidney transplant.
- Trial name
- NCT00239798
- Testing
- FTY720
- Volunteers
- 255 people
- Sponsor
- Novartis Pharmaceuticals
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.
Tacrolimus-associated Abnormal Glucose Metabolism in Kidney and Liver Transplant Recipients
Safety and Efficacy of Converting Maintenance Kidney and Liver Transplant Recipients With Abnormal Glucose Metabolism From Tacrolimus to Cyclosporine Micro-emulsion
New onset diabetes mellitus (NODM) post- transplantation decreases patient and graft survival. Some immunosuppressive agents are associated with a higher incidence of NODM.
- Trial name
- NCT00150085
- Testing
- cyclosporine micro-emulsion
- Volunteers
- 50 people
- Sponsor
- Novartis
Renal Transplantation
This is a 2-year Follow-up Study to Evaluate the Long-term Effects in Patients Who Completed the Study CRAD001A2307.
This extension study is designed to provide long-term safety and efficacy data beyond 12 months up to Month 36.
- Trial name
- NCT00531440
- Testing
- Everolimus (RAD001)
- Where
- Switzerland
- Volunteers
- 256 people
- Sponsor
- Novartis Pharmaceuticals
Heart Transplantation
Efficacy and Safety of Everolimus in de Novo Heart Transplant Recipients
This study will test the safety and efficacy of everolimus on heart transplant recipients. This study is not recruiting in the United States.
- Trial name
- NCT00150046
- Testing
- Everolimus
- Where
- 2 sites in Germany, Switzerland
- Volunteers
- 176 people
- Sponsor
- Novartis Pharmaceuticals
Renal Transplantation
A Twelve-month, Multicenter, Open-label, Randomized Study of the Safety, Tolerability and Efficacy of Everolimus With Basiliximab, Corticosteroids and Two Different Exposure Levels of Tacrolimus in de Novo Renal Transplant Recipients
This study is designed to evaluate whether tacrolimus dose reduction in de novo renal recipients receiving everolimus can preserve renal function while maintaining efficacy.
- Trial name
- NCT00369161
- Testing
- Everolimus (RAD001), Tacrolimus, Basiliximab
- Where
- Switzerland
- Volunteers
- 228 people
- Sponsor
- Novartis
Heart Transplantation
Heart Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Heart Transplant Recipients
Heart transplant patients on a standard care regimen of CNI, MMF, and corticosteroids will enter the study 4-6 weeks post-transplant.
- Trial name
- NCT00121784
- Testing
- mycophenolate mofetil [CellCept]
- Where
- 29 sites in United States, Australia and 4 more
- Volunteers
- 12 people
- Sponsor
- Hoffmann-La Roche
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
BK Viremia; BKV DNAemia
Safety, Tolerability and Efficacy of AntiBKV as Treatment of BKV Infection in Kidney Transplant Recipients
The purpose of this study is to evaluate the safety, tolerability, and efficacy of AntiBKV in reducing BKV DNAemia and progression to biopsy-confirmed BKVAN in kidney transplant recipients.
- Trial name
- SAFE KIDNEY II (NCT05769582)
- Testing
- Anti-BK polyomavirus (AntiBKV)
- Where
- 23 sites in United States
- Volunteers
- 95 people
- Sponsor
- Memo Therapeutics AG
Kidney Transplantation
24 Month Extension to Efficacy and Safety of AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months) in Renal Transplant Patients(Converted to Mycophenolic Acid After 3 Months) in Renal Transplant Patients
This study will provide continued treatment and assess the long term safety, efficacy and tolerability of oral AEB071 plus tacrolimus vs. mycophenolic acid plus tacrolimus after kidney transplantation.
- Trial name
- NCT00555789
- Testing
- AEB071, mycophenolic plus tacrolimus
- Where
- 27 sites in United States, Canada and 6 more
- Volunteers
- 137 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplant Recipients
Non Invasive Blood Test To Diagnose Acute Rejection After Kidney Transplantation
This is a prospective, multicenter, observational study of kidney transplant subjects where blood specimens, intended for dd-cfDNA and other future research purposes, will be drawn after transplant
- Trial name
- DART (NCT02424227)
- Where
- 14 sites in United States
- Volunteers
- 401 people
- Sponsor
- CareDx