Clinical trials: Renal Transplant Infection
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
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
Cancer
Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain
This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the clinical response to fentanyl sublingual spray as a treatment for breakthrough cancer pain.
- Trial name
- NCT00538850
- Testing
- Fentanyl sublingual spray
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- INSYS Therapeutics Inc
Herpes Zoster
A Study to Test GlaxoSmithKline's (GSK) Herpes Zoster (HZ) Subunit Vaccine's Long-term Immune Response in Previously Vaccinated Kidney Transplant Adults and Then to Test if 2 Additional Doses of the Vaccine Are Safe and Able to Generate an Immune Response
The purpose of this study was to evaluate the long-term immune responses to the Herpes Zoster subunit (HZ/su) vaccine as well as safety up to 7 years after the 2-dose primary vaccination course from study ZOSTER-041…
- Trial name
- NCT04176939
- Testing
- HZ/su vaccine (GSK1437173A)
- Where
- 15 sites in Belgium, Canada and 5 more
- Volunteers
- 68 people
- Sponsor
- GlaxoSmithKline
BK Virus Infection
A Safety, Pharmacokinetics and Efficacy Study of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients
This clinical research study will test the safety and efficacy of the investigational medication MAU868, compared to a placebo, in patients who have had a kidney transplant who have active BK virus.
- Trial name
- NCT04294472
- Testing
- MAU868
- Where
- 18 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- Vera Therapeutics, Inc.
Transplantation Infection
Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients
The purpose of this study was to allow the continuation of everolimus treatment in patients who have completed the core study (NCT00170885) and to collect long-term safety, tolerability, and efficacy data in a group of patients…
- Trial name
- EVEREST (NCT01276457)
- Testing
- Everolimus 0.25 and 0.75 mg tablets, Cyclosporine very low dose (150-300 ng/mL) microemulsion, Cyclosporine low dose (350-500 ng/mL) microemulsion
- Volunteers
- 223 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Diseases, Kidney Injury
ID-ENTITY Trial- Evaluating Serial T-ID Monitoring
To evaluate the association between time-updated CMV and BK viral loads measured monthly by T-ID and the risk of CMV disease and/or biopsy-proven BK virus-associated nephropathy (BKVAN) during the first 12 months following kidney…
- Conditions
- Kidney Diseases, Kidney Injury, BK Virus Infection, CMV
- Trial name
- ID-ENTITY (NCT07393594)
- Testing
- Blood tests, TRAC( cell free DNA) and T-ID
- Where
- 14 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Transplant Genomics, Inc.
Cytomegalovirus Infection, Cytomegalovirus Disease
MK-8228 (Letermovir) in the Prevention of Human Cytomegalovirus (CMV) Infection and Disease in Adult Japanese Kidney Transplant Recipients (MK-8228-042)
This study aims to evaluate the safety, efficacy and pharmacokinetics (PK) of Letermovir (LET) administered as prevention of cytomegalovirus (CMV) infection and disease in adult Japanese kidney transplant recipients.
- Trial name
- NCT04129398
- Testing
- Letermovir tablet, Letermovir IV
- Where
- 4 sites in Japan
- Volunteers
- 22 people
- Sponsor
- Merck Sharp & Dohme LLC
Kidney Transplant Infection
Effects of a Food Supplement in the Prevention of Urinary Tract Infections in Kidney Transplant Patients.
The incidence of Urinary tract infections (UTIs) is very high in kidney transplant patients. Most UTIs occur during the first six months (82% within the first three months) of kidney transplantation and are frequently recurrent.
- Trial name
- MANOTRAS (NCT05109455)
- Testing
- MANOSAR®, Proanthocyanidins
- Where
- Spain
- Volunteers
- 60 people
- Sponsor
- Arafarma Group, S.A.
Cytomegalovirus Disease
A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus Disease
To compare the efficacy of oral brincidofovir (BCV) to valganciclovir (vGCV) for the prevention of cytomegalovirus (CMV) disease in kidney transplant allograft recipients who are CMV seronegative pretransplant and received a…
- Trial name
- SUSTAIN (NCT02439970)
- Testing
- Brincidofovir, Valganciclovir
- Where
- 3 sites in United States
- Volunteers
- 5 people
- Sponsor
- Jazz Pharmaceuticals
Cytomegalovirus Disease
A Study for Kidney Transplant Recipients at High-Risk of Cytomegalovirus Infection
The primary objective is to assess the efficacy and safety of NPC-21 when administered prophylactically to cytomegalovirus (CMV) seronegative patients receiving a first kidney transplant from a CMV seropositive donor.
- Trial name
- NCT04225923
- Testing
- NPC-21 Low dose, NPC-21 High dose
- Where
- 28 sites in United States, Japan
- Volunteers
- 87 people
- Sponsor
- Nobelpharma
BK Virus Infection, BKV Infection
A Trial to Evaluate the Safety, Tolerability and Efficacy of AIC263029 in Kidney Transplant Recipients With BKV Infection
The goal of this clinical trial is to learn if AIC263029 is safe and well tolerated in adult kidney transplant recipients with BK virus (BKV) in the blood (viremia).
- Conditions
- BK Virus Infection, BKV Infection, Kidney Transplant
- Trial name
- NCT07503561
- Testing
- AIC263029
- Where
- 7 sites in United States
- Volunteers
- 24 people
- Sponsor
- AiCuris Anti-infective Cures AG
Respiratory Syncytial Virus Infections
A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant
This study evaluates persistence of the immune response of the adjuvanted RSV vaccine and the safety and immunogenicity following revaccination in adults 18 years of age and above who received lung or kidney transplant.
- Trial name
- NCT07092865
- Testing
- Adjuvanted RSVPreF3 vaccine
- Where
- 38 sites in United States, Australia and 6 more
- Volunteers
- 168 people
- Sponsor
- GlaxoSmithKline
Cytomegalovirus (CMV)
A Study of Cytomegalovirus (CMV) Infection After Kidney Transplant in Adults in the United Kingdom
This observational study intends to retrospectively gather information on cytomegalovirus (CMV) infection management in the United Kingdom (UK) over a period of 7 years (2017-2024).
- Trial name
- NCT06568055
- Testing
- No Intervention
- Where
- United Kingdom
- Volunteers
- 330 people
- Sponsor
- Takeda
Herpes Zoster
Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine in Adults 18 Years of Age or Older With Renal Transplant
The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' HZ/su vaccine administered on a 0- and 1- to 2-months schedule in adults 18 years of age or older who are receiving chronic…
- Trial name
- NCT02058589
- Testing
- Herpes Zoster vaccine GSK1437173A
- Where
- 34 sites in Belgium, Canada and 7 more
- Volunteers
- 265 people
- Sponsor
- GlaxoSmithKline
COVID-19
Immunogenicity and Safety of a Booster Dose of the SpikoGen Vaccine in Kidney Transplant Recipients After Two Doses of Sinopharm Vaccine
This is an open-label, single-arm clinical trial designed to evaluate the immunogenicity and safety of a booster dose of an adjuvanted recombinant SARS-CoV-2 spike protein subunit vaccine (SpikoGen) produced by CinnaGen Co.
- Trial name
- NCT05285384
- Testing
- SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant
- Where
- Iran
- Volunteers
- 43 people
- Sponsor
- Cinnagen
Respiratory Syncytial Virus Infections
A Study on the Immune Response and Safety of an RSV Vaccine When Given to Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant and Are at an Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease and Compared to Healthy Adults 50 Years of Age and Above
The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicity of the RSVPreF3 OA investigational vaccine in an immunocompromised (lung and renal transplant recipients) population and assess whether a…
- Trial name
- RSV OA=ADJ-023 (NCT05921903)
- Testing
- RSVPreF3 OA Investigational Vaccine
- Where
- 46 sites in United States, Australia and 6 more
- Volunteers
- 386 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Clostridium Difficile Infection Recurrence
Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff
Subjects with recurrent C. difficile infection will receive an oral dose of CP101 capsules one time in Treatment Group I or matching placebo one time in Treatment Group II.
- Trial name
- PRISM3 (NCT03110133)
- Testing
- Full Spectrum Microbiota
- Where
- 58 sites in United States, Canada
- Volunteers
- 206 people
- Sponsor
- Finch Research and Development LLC.
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