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An Open Label Trial Evaluating Tacrolimus Inhalation Powder in Adult Lung Transplant Recipients
This is an open label, multicenter, safety and PK study comparing safety, efficacy, and pharmacokinetic (PK) levels of Tacrolimus Inhalation Powder in lung transplant patients that require reduced tacrolimus blood levels due to kidney toxicity. Part A of the study will consist of a 12 week safety, efficacy, and PK study. Part B of the study will be an optional safety extension following successful completion of the 12 week safety, efficacy, and PK study.
Patients would have the option to continue Tacrolimus Inhalation Powder for up to 1 year, with a possibility to extend to 2 years depending on the results from Part A.
Study details:
This is an open label, single-arm study that will evaluate the safety and PK of Tacrolimus Inhalation Powder in lung transplant patients who require reduced blood levels of tacrolimus due to kidney toxicity. Tacrolimus Inhalation Powder is being developed as an alternative to oral tacrolimus in adult lung transplant recipients. Patients enrolled in this study will have been receiving an oral dose of tacrolimus after a successful lung transplant that is resulting in kidney toxicity.
During Part A, the patients will be transferred into the study with the anticipation of switching to inhaled tacrolimus with the goal of reducing blood levels to stabilize or minimize kidney toxicity while maintaining sufficiently high lung tacrolimus levels to prevent allograft rejection. Once the study patients are enrolled, they will return to the clinic on a regular basis to allow for dose adjustment. Therapeutic tacrolimus drug concentrations will be measured at every clinic visit under trough conditions (i.
e. , pre-dose). Kidney function testing will also be monitored on a regular basis.
Part B of this study is an optional safety extension following successful completion of Part A. Patients would have the option to continue Tacrolimus Inhalation Powder for up to 1 year, with a possibility to extend to 2 years pending analysis of Part A data. Participants would return to clinic periodically for safety assessments, dose adjustments, and to receive more Tacrolimus Inhalation Powder.
After 2 years, if the drug is still under development, the subject will be invited to continue receiving tacrolimus inhalation powder under a special access program.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-04-18
Primary completion: 2025-01-31
Study completion finish: 2025-01-31
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT05501574
Intervention or treatment
DRUG: Tacrolimus Inhalation Powder
Conditions
- • Lung Transplant Rejection
Find a site
Closest Location:
The Alfred Hospital
Research sites nearby
Select from list below to view details:
The Alfred Hospital
Melbourne, Victoria, Australia
St Vincent's Hospital
Darlinghurst, New South Wales, Australia
Prince Charles Hospital
Brisbane, Queensland, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Tacrolimus Inhalation Powder
| DRUG: Tacrolimus Inhalation Powder
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| Number of participants experiencing Adverse Events, Serious Adverse Events, and withdrawals due to Adverse Events | Number of AEs, SAEs, and discontinuation due to AEs | Baseline through end of study (up to 2 years) |
| Number of participants who experience laboratory test abnormalities | Number of participants with potentially clinically significant lab test values | Baseline through end of study (up to 2 years) |
| Number of participants who experience physical examination abnormalities | Number of participants with potentially clinically significant physical examination abnormalities | Baseline through end of study (up to 2 years) |
| Number of participants who experience pulse oximetry abnormalities | Number of participants with potentially clinically significant pulse oximetry values | Baseline through end of study (up to 2 years) |
| Number of participants who experience vital sign abnormalities | Number of participants with potentially clinically significant vital sign values | Baseline through end of study (up to 2 years) |
| Mean change from baseline in chest radiology | Number of participants with potentially clinically significant changes in chest radiology | Baseline through end of study (up to 2 years) |
| Mean change from baseline in blood serum creatinine | Number of participants with potentially clinically significant changes in blood serum creatinine | Baseline through end of study (up to 2 years) |
| Mean change from baseline in estimated glomerular flow rate (eGFR) | Number of participants with potentially clinically significant changes in eGFR | Baseline through end of study (up to 2 years) |
| Mean change from baseline in forced expiratory volume (FEV1) | Spirometry used to measure FEV1 lung function | Baseline through end of study (up to 2 years) |
| Mean change from baseline in forced vital capacity (FVC) | Spirometry used to measure FVC lung function | Baseline through end of study (up to 2 years) |
| Mean change from baseline in FEV1/FVC ratio | Spirometry used to measure FEV1 and FVC lung function | Baseline through end of study (up to 2 years) |
| Number of participants meeting treatment stopping rules of acute allograft rejection | Number of participants meeting treatment stopping rules of acute allograft rejection | Baseline through end of study (up to 2 years) |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| Change from baseline in FEV1 percent predicted | Spirometry used to measure FEV1 lung function | Baseline through end of study (up to 2 years) |
| PK of tacrolimus in whole blood AUC0-6 | PK of tacrolimus in whole blood: Area under the plasma-concentration time curve (AUC0-6) from time 0 through 6 hours after dosing | Baseline through week 12 |
| PK of tacrolimus in whole blood AUClast | PK of tacrolimus in whole blood: Area under the plasma-concentration time curve (AUClast) from time of dosing to the last measurable concentration | Baseline through week 12 |
| PK of tacrolimus in whole blood Cmax | PK of tacrolimus in whole blood: Maximum observed concentration (Cmax) | Baseline through week 12 |
| PK of tacrolimus in whole blood Tmax | PK of tacrolimus in whole blood: Time to maximal observed concentration (Tmax) | Baseline through week 12 |
| Incidence of all-cause mortality | Incidence of all-cause mortality | Baseline through end of study (up to 2 years) |
| Incidence of allograft-related mortality | Incidence of allograft-related mortality | Baseline through end of study (up to 2 years) |
| Incidence of all-cause hospitalizations | Incidence of all-cause hospitalizations | Baseline through end of study (up to 2 years) |
| Incidence of acute allograft-related hospitalizations | Incidence of acute allograft-related hospitalizations | Baseline through end of study (up to 2 years) |
Frequently Asked Questions
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