Virus Diseases Clinical Trial
Official title:
Polyomavirus BK Nephropathy After Renal Transplantation: Randomized Clinical Trial to Demonstrate That Switching to mTOR Inhibitor is More Effective Than a Reduction of Immunosuppressive Therapy
Polyomavirus BK nephropathy is a serious complication after renal transplantation leading to graft loss in 40% of cases. Since no virustatic drug exists, the investigators want to study the best way to manage viral invasion by changing the immunosuppressive treatment comparing two treatment schemes. The investigators hypothesis is that switching to an mTOR-based scheme is superior to a general decrease of a calcineurin inhibitor (CNI)-based scheme. The study will be performed as a prospective, randomized, parallel group comparison.
The study group (n=62) will be switched from CNI to everolimus while the control group (n=62) will get a general reduction of the CNI-based immunosuppression. Follow-up and duration of intervention per patient will be 24 months, duration of the trial 72 months including 4 years of recruitment. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04074928 -
Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects
|
Phase 3 | |
Completed |
NCT03321968 -
Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults
|
Phase 3 | |
Completed |
NCT04644484 -
A Phase III Clinical Study to Evaluate SYN023's Efficacy and Safety
|
Phase 3 | |
Completed |
NCT00984945 -
Safety Study of a Plant-based H5 Virus-Like Particles (VLP) Vaccine in Healthy Adults
|
Phase 1 | |
Completed |
NCT00734175 -
Safety of and Immune Response to Recombinant Live-Attenuated Influenza H6N1 Virus Vaccine Vaccine
|
Phase 1 | |
Completed |
NCT00516035 -
Single Group Study of the Safety of and Immune Response to a Bird Flu Vaccine (H7N3) in Healthy Adults
|
Phase 1 | |
Active, not recruiting |
NCT05284097 -
Ad26.ZEBOV, MVA-BN-Filo Vaccination in Children and Adults Previously Vaccinated With Control in the EBOVAC-Salone Study
|
Phase 2 | |
Completed |
NCT03739112 -
Efficacy of a Plant-derived Quadrivalent Virus-like Particle (VLP) Vaccine in the Elderly
|
Phase 3 | |
Recruiting |
NCT06113757 -
Investigation of Efficacy and Safety of Electrical Signal Therapy Provided by Dr Biolyse® Device in COVID-19 Disease
|
N/A | |
Completed |
NCT01991587 -
Safety, Tolerability and Immunogenicity of a Plant-made Seasonal Quadrivalent VLP Influenza Vaccine in Adults
|
Phase 1/Phase 2 | |
Completed |
NCT03294135 -
The Aim of This Study is to Investigate the Persistence of Antibody Response in Adults up to 15 Years After One Booster Dose of GlaxoSmithKline (GSK) Biologicals' Encepur Adults Vaccine
|
Phase 4 | |
Active, not recruiting |
NCT02545517 -
A Clinical Study to Evaluate Immune Responses to Rabies Vaccine in Adults Who Received Different Primary Rabies Vaccination Regimens
|
Phase 3 | |
Active, not recruiting |
NCT05619770 -
Study to Evaluate Pharmacokinetics, Safety & Tolerability of 101-PGC-005 in Healthy, Adult, Human Subjects
|
Phase 1 | |
Active, not recruiting |
NCT01055990 -
Basic and Clinical Research on Applying Blood Fix to Treat Critical H1N1 Patients
|
Phase 2 | |
Completed |
NCT01842997 -
Safety of H1N1 Influenza Vaccination in Pregnant Women
|
Phase 4 | |
Completed |
NCT00980447 -
Immunogenicity, Safety and Optimal Dose Finding Study of Recombinant Influenza H5N1 Vaccine in Healthy Young Adults
|
Phase 2 | |
Completed |
NCT00380237 -
Safety of and Immune Response to a Bird Flu Virus Vaccine (H9N2) in Healthy Adults (Study B)
|
Phase 1 | |
Completed |
NCT00219453 -
Pilot Safety Study to Determine the Ability of the Protector Cap Jet Injector to Prevent Cross-Contamination
|
Phase 1 | |
Completed |
NCT02548078 -
A Study to Evaluate the Safety and Immunogenicity of a Candidate Ebola Vaccine in Children
|
Phase 2 | |
Completed |
NCT01480258 -
Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months (V419-008)
|
Phase 3 |