Clinical trials: Lung Transplant Recipients
Fungal Infection
A Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients (MK-5592-105)
This single site study will examine plasma and alveolar compartment (AC) levels of posaconazole in cystic fibrosis (CF) and non-cystic fibrosis (non-CF) lung transplant recipients receiving routine post-operative anti-fungal…
- Trial name
- PAPAL (NCT01667107)
- Testing
- Posaconazole, Calogen®
- Volunteers
- 26 people
- Sponsor
- Merck Sharp & Dohme LLC
Aspergillosis, Lung Transplant Infection
The Effect of Early Treatment of PC945 on Aspergillus Fumigatus Lung Infection in Lung Transplant Patients.
This study tests the effects of pre-emptive treatment with an experimental drug PC945 in lung transplant recipients whose lungs are infected by the fungus Aspergillus fumigatus.
- Trial name
- NCT03905447
- Testing
- PC945, Standard of Care
- Where
- 3 sites in United Kingdom
- Volunteers
- 2 people
- Sponsor
- Pulmocide Ltd
SARS-CoV-2
A Study to Evaluate Safety and Immunogenicity of mRNA-1273 Vaccine to Prevent COVID-19 in Adult Organ Transplant Recipients and in Healthy Adult Participants
This is an open-label study to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1273 Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) vaccine in adults with a kidney or liver solid organ transplant (SOT)…
- Trial name
- NCT04860297
- Testing
- mRNA-1273
- Where
- 15 sites in United States
- Volunteers
- 234 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Lung Transplant Rejection
An Open Label Trial Evaluating the Safety, Tolerability, Efficacy and Pharmacokinetic Profile of Tacrolimus Inhalation Powder in Adult Lung Transplant Recipients
Part A: This is an open label, single-arm study that will evaluate the safety, tolerability, efficacy and PK of Tacrolimus Inhalation Powder over 12 weeks in lung transplant patients who require reduced blood levels of tacrolimus…
- Trial name
- NCT05501574
- Testing
- Tacrolimus Inhalation Powder, Plastiape RS00 Dry Powder inhaler device
- Where
- 2 sites in Australia
- Volunteers
- 14 people
- Sponsor
- TFF Pharmaceuticals, Inc.
Heart Transplantation, Lung Transplantation
Study to Compare the Pharmacokinetics of Tacrolimus in Adult Transplant Recipients Treated With Advagraf® or Prograf®
Comparison of tacrolimus blood levels in adults who have received a transplant and are taking either Prograf or Advagraf anti-rejection therapy immediately following surgery.
- Conditions
- Heart Transplantation, Lung Transplantation, Pancreas (Including SPK) Transplantation
- Trial name
- NCT01332201
- Testing
- Advagraf, Prograf
- Where
- 8 sites in Austria, Belgium and 4 more
- Volunteers
- 17 people
- Sponsor
- Astellas Pharma Inc
Respiratory Syncytial Virus (RSV)
Presatovir in Lung Transplant (LT) Recipients With Respiratory Syncytial Virus (RSV) Infection
The primary objective of this study is to evaluate the effect of presatovir on nasal respiratory syncytial virus (RSV) viral load in RSV-positive lung transplant (LT) recipients with acute respiratory symptoms.
- Trial name
- NCT02534350
- Testing
- Presatovir
- Where
- 28 sites in United States, Australia and 6 more
- Volunteers
- 61 people
- Sponsor
- Gilead Sciences
Intestine Transplantation, Kidney Transplantation
Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From Prograf® to Advagraf®
Parts A \& B: Conversion of stable pediatric allograft recipients from Prograf® immunosuppression to Advagraf® immunosuppression to compare exposure and one year follow-up for safety and efficacy.
- Conditions
- Intestine Transplantation, Kidney Transplantation, Lung Transplantation, Liver Transplantation
- Trial name
- NCT01294020
- Testing
- Tacrolimus, Tacrolimus prolonged release
- Where
- 16 sites in Belgium, Czechia and 5 more
- Volunteers
- 81 people
- Sponsor
- Astellas Pharma Europe Ltd.
Lung Transplant
Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients
Currently there are no approved therapies for lung transplant recipients in the United States (US). Treatment with CIS following lung transplantation has previously been demonstrated to result in a clinically meaningful…
- Trial name
- NCT00633373
- Testing
- Cyclosporine Inhalation Solution
- Where
- 8 sites in United States
- Sponsor
- APT Pharmaceuticals, Inc.
Invasive Aspergillosis
Assessment of Volatile Organic Compounds (VOC) for the Diagnosis of Invasive Aspergillosis (IA) in Lung Transplant Recipients
Prospective observational pilot study to evaluate the utility of breath VOCs to detect invasive aspergillosis in lung transplant recipients that are suspected of invasive fungal disease (IFD).
- Trial name
- UHN (NCT06344117)
- Where
- Canada
- Volunteers
- 45 people
- Sponsor
- Owlstone Ltd
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
Lung Transplantation
Efficacy Regarding Renal Function of Everolimus in Combination With Specific Standard Immunosuppressive Regimen Lung Transplant Recipients
This trial evaluated the efficacy of an everolimus-based quadruple low immunosuppressive regimen versus a standard immunosuppressive regimen concerning kidney function in lung transplant recipients.
- Trial name
- 4EVERLUNG (NCT01404325)
- Testing
- standard therapy, Everolimus
- Where
- 9 sites in Germany
- Volunteers
- 130 people
- Sponsor
- Novartis Pharmaceuticals
Invasive Aspergillosis, Invasive Pulmonary Aspergillosis
VL-2397 Compared to Standard First-Line Treatment for Invasive Aspergillosis (IA) in Adults
The purpose of the trial is to evaluate the safety and efficacy of a new antifungal with a novel mechanism of action in immunocompromised adults with invasive aspergillosis.
- Trial name
- NCT03327727
- Testing
- Investigational Agent: VL-2397, Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B
- Where
- 28 sites in United States, Belgium and 4 more
- Volunteers
- 4 people
- Sponsor
- Vical
Lung Transplantation
A Study of Mycophenolate Mofetil (CellCept) in Lung Transplant Recipients
This open-label, single center study will assess the pharmacokinetics, efficacy and safety of mycophenolate mofetil in lung allograft recipients.
- Trial name
- NCT01014442
- Testing
- mycophenolate mofetil
- Where
- Germany
- Volunteers
- 68 people
- Sponsor
- Hoffmann-La Roche
Cytomegalovirus Infections
A Relative Bioavailability Study of Valcyte (Valganciclovir) in Lung Transplant Recipients With or Without Cystic Fibrosis.
This study will assess the relative bioavailability of ganciclovir from the pro-drug valganciclovir in lung transplant recipients with or without cystic fibrosis.
- Trial name
- NCT00377741
- Testing
- valganciclovir [Valcyte]
- Where
- 5 sites in United States
- Volunteers
- 31 people
- Sponsor
- Hoffmann-La Roche
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
Disorder Related to Cardiac Transplantation
Nordic Everolimus (Certican) Trial in Heart and Lung Transplantation
This study investigated whether initiation of everolimus together with reduction of calcineurin inhibitors (CNI) in maintenance heart or lung transplant patients with renal impairment would improve renal function.
- Trial name
- NOCTET (NCT00377962)
- Testing
- Everolimus, Mycophenolic acid (MPA)/azathioprine (AZA), Calcineurin inhibitors (CNI)
- Where
- 6 sites in Denmark, Norway and 1 more
- Volunteers
- 282 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Obstructive Pulmonary, Idiopathic Pulmonary Fibrosis
EZ-2053 in the Prophylaxis of Acute Pulmonary Allograft Rejection
The purpose of this study is to assess the efficacy and safety of the study drug, known as "ATG Fresenius S," which is sometimes called "EZ-2053," to prevent a lung transplant patient's body from rejecting a transplanted lung or…
- Conditions
- Chronic Obstructive Pulmonary, Idiopathic Pulmonary Fibrosis, Cystic Fibrosis, Bronchiectasis
- Trial name
- NCT00105183
- Testing
- EZ-2053, EZ-2053 5mg/kg
- Where
- 19 sites in United States, Australia and 2 more
- Volunteers
- 223 people
- Sponsor
- Neovii Biotech
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
Pulmonary Aspergillosis
An Open-label Safety Study of PC945 (Opelconazole) Prophylaxis or Pre-emptive Therapy Against Pulmonary Aspergillosis in Lung Transplant Recipients (OPERA-S Study)
A study to evaluate the safety and tolerability of opelconazole for the prevention of fungal aspergillus infections in the lung in participants who have received a lung transplant.
- Trial name
- NCT05037851
- Testing
- Opelconazole, Standard of Care
- Where
- 19 sites in United States, Canada
- Volunteers
- 102 people
- Sponsor
- Pulmocide Ltd
Lung Transplant
CIS001 Extension Study of Cyclosporine Inhalation Solution
This trial is a longterm follow up of a phase III study of inhaled cyclosporine for the prevention of chronic rejection in lung transplant recipients.
- Trial name
- CIS002 (NCT00938236)
- Testing
- Cyclosporine Inhalation Solution (CIS)
- Where
- 16 sites in United States, Canada
- Volunteers
- 17 people
- Sponsor
- APT Pharmaceuticals, Inc.