An Open Label Trial Evaluating Tacrolimus Inhalation Powder in Adult Lung Transplant Recipients

Lung Transplant Rejection Clinical Trial

Official title: An Open Label Trial Evaluating the Safety and PK Profile of Tacrolimus Inhalation Powder in Adult Lung Transplant Recipients

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Lung Transplant Rejection
• Respiratory Aspiration

• NCT number: NCT05501574
• Study type: Interventional
• Source: TFF Pharmaceuticals, Inc.
• Status: Recruiting
• Phase: Phase 2
• Start date: April 18, 2023
• Completion date: January 31, 2025