Clinical trials: Renal Transplant Recipient
Renal Transplantation
Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients
Clinical trial for the novo transplant recipients, which aims to assess tolerability and safety and clinical outcomes of EC-MPS in combination with cyclosporine microemulsion (CsA-ME) with or without steroids in a population of…
- Trial name
- NCT00238953
- Testing
- Enteric-Coated Mycophenolate Sodium (EC-MPS)
- Where
- Switzerland
- Volunteers
- 30 people
- Sponsor
- Novartis
Kidney Transplant
Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in a Cyclosporine Microemulsion Based Regimen in de Novo Living Donor Kidney Transplant Recipients
This study will evaluate the efficacy and safety of enteric-coated mycophenolate sodium (EC-MPS) in a cyclosporine microemulsion based regimen with C2 monitoring in de novo kidney transplant recipients
- Trial name
- NCT00537862
- Testing
- Enteric-Coated Mycophenolate Sodium (EC-MPS)
- Where
- 8 sites in South Korea
- Volunteers
- 200 people
- Sponsor
- Novartis Pharmaceuticals
De Novo Kidney Transplant Recipients
Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients
This trial is designed to assess the efficacy, tolerability, and safety of EC-MPS in combination with cyclosporine microemulsion (CsA-ME) with or without steroids in kidney transplant recipients.
- Trial name
- NCT00312143
- Testing
- Enteric-coated Mycophenolate sodium (EC-MPS)
- Volunteers
- 35 people
- Sponsor
- Novartis
Graft Rejection, Kidney Failure
Study Comparing Two Sirolimus Regimens vs. Tacrolimus and Mycophenolate Mofetil Regimen in Kidney Transplant Recipients
To demonstrate the superiority of SRL + TAC elimination + corticosteroids (Group I) and SRL + MMF + corticosteroids (Group II) to TAC + MMF + corticosteroids (Group III) with respect to renal allograft function at month 12…
- Conditions
- Graft Rejection, Kidney Failure, Kidney Transplant
- Trial name
- NCT00266123
- Testing
- Sirolimus
- Volunteers
- 420 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Cytomegalovirus (CMV) Infection, Kidney Transplantation
A Study of CMV Vaccine (HB-101) in Kidney Transplant Patients
HB-101 is a bivalent recombinant vaccine against human CMV infection. This is a randomized, placebo-controlled, phase 2 study to assess the safety, reactogenicity, immunogenicity, and efficacy of HB-101 in CMV-Seronegative…
- Trial name
- NCT03629080
- Testing
- HB-101 vaccine
- Where
- 25 sites in United States, Denmark and 4 more
- Volunteers
- 83 people
- Sponsor
- Hookipa Biotech GmbH
Pharmacokinetics Study in de Novo Kidney Transplantation
Comparison of a Tacrolimus Hexal® Based Regimen Versus a Prograf® Based Regimen in de Novo Renal Transplant Recipients
The purpose of this study was to investigate if Tacrolimus Hexal® has similar pharmacokinetic properties compared to Prograf® in de novo renal transplant patients and whether the comparable exposure resulted in similar renal…
- Trial name
- Spartacus (NCT01649427)
- Testing
- Prograf, Tacrolimus Hexal
- Where
- 5 sites in Germany
- Volunteers
- 73 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Tansplant, Secondary Hyperparathyroidism
Post Transplant Study
Retrospective chart review to gather information on Sensipar patterns of use and effects on biochemical parameters in renal transplant recipients
- Conditions
- Kidney Tansplant, Secondary Hyperparathyroidism, Hyperparathyroidism
- Trial name
- NCT00395902
- Testing
- Sensipar after Post Transplant
- Volunteers
- 50 people
- Sponsor
- Amgen
Kidney Transplantation
Retrospective Study of Long-term Survival and Related Factors Among Kidney Transplant Recipients in China
The primary objective of this study is to evaluate graft survival and recipient survival among kidney transplant recipients in China, and also to analyze possible factors related to patient and graft survival.
- Trial name
- REACH (NCT01796639)
- Where
- 18 sites in China
- Volunteers
- 1,500 people
- Sponsor
- Novartis
Kidney Transplantation
Efficacy, Safety and Evolution of Cardiovascular Parameters in Renal Transplant Recipients
The purpose of this study was to determine whether an early Calcineurin Inhibitor (CNI) to everolimus conversion at 10-14 weeks post transplantation improves renal allograft function without compromising efficacy compared to…
- Trial name
- ELEVATE (NCT01114529)
- Testing
- Everolimus, Prograf or Neoral
- Where
- 77 sites in Argentina, Australia and 19 more
- Volunteers
- 828 people
- Sponsor
- Novartis Pharmaceuticals
Cytomegalovirus Infections, Preventation of Cytomegalovirus Reactivation
Evaluate Tolerability and Safety of BD03 for Prevention of CMV and BKV Reactivation in Kidney Transplant Recipient
This study is a phase I, open-label study to determine recommended phase 2 dose (RP2D) for the BD03 vaccination in kidney transplant recipients.
- Conditions
- Cytomegalovirus Infections, Preventation of Cytomegalovirus Reactivation, BK Virus Infection, Preventation of BK Virus Reactivation
- Trial name
- NCT03576014
- Testing
- BD03
- Where
- 2 sites in South Korea
- Volunteers
- 18 people
- Sponsor
- SL VAXiGEN
Kidney Transplant, Immunosuppresion
Immunosuppression Optimization Using The Prospera Assay In Kidney Transplant Recipients (IMPAKT)
IMPAKT is a research study that looks at whether a blood test called Prospera™ can help doctors better adjust anti-rejection medications, compared to the usual way doctors manage these medications without using this test.
- Trial name
- IMPAKT (NCT07718633)
- Testing
- Prospera Immunosuppression Optimization
- Volunteers
- 750 people
- Sponsor
- Natera, Inc.
Chronic Allograft Injury
A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Zampilimab in Adult Kidney Transplant Recipients With Chronic Allograft Injury
The main purpose of the study is to investigate the safety and tolerability of repeat dosing with zampilimab in kidney transplant recipients with deteriorating kidney function associated with chronic allograft injury (CAI).
- Trial name
- NCT04335578
- Testing
- Zampilimab
- Where
- 5 sites in Australia, Belgium and 2 more
- Volunteers
- 3 people
- Sponsor
- UCB Biopharma SRL
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
Renal Transplantation
Study Comparing Conversion to Sirolimus vs. Continued Use of Calcineurin Inhibitors in Kidney Transplant Recipients
The purpose of this study is to determine the effect of conversion from calcineurin inhibitor to sirolimus based therapy on renal function.
- Trial name
- NCT00038948
- Testing
- Sirolimus, tacrolimus, Cyclosporine A
- Volunteers
- 830 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
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
Efficacy, Safety and Tolerability of AEB071 Versus Cyclosporine in the Novo Renal Transplant Recipients
This study will assess safety and efficacy of AEB071 combined with everolimus in a CNI-free (calcineurin inhibitor) regimen in renal transplant recipients.
- Trial name
- AEB071 (NCT00504543)
- Testing
- AEB071, Certican, Neoral
- Where
- 26 sites in Argentina, Australia and 15 more
- Volunteers
- 311 people
- Sponsor
- Novartis Pharmaceuticals
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
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
A Study to Assess the Safety and Efficacy of a Tacrolimus Based Immunosuppressive Regimen in Stable Kidney Transplant Recipients Converted From Cyclosporine Based Immunosuppressive Regimen
The objective of this study is to observe and evaluate the change in renal function following conversion from cyclosporine-based immunosuppressive regimen to tacrolimus-based one.
- Trial name
- NCT02963103
- Testing
- Tacrolimus
- Where
- South Korea
- Volunteers
- 13 people
- Sponsor
- Astellas Pharma Korea, Inc.
Renal Transplantation
Extension Study on the Safety and Efficacy of Enteric-coated Mycophenolate Sodium in Kidney Transplant Recipients
This extension study is to assess the long-term safety of EC-MPS
- Trial name
- NCT00239070
- Testing
- Enteric-Coated Mycophenolate Sodium (EC-MPS)
- Volunteers
- 69 people
- Sponsor
- Novartis