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Phase 2Terminated

An Open Label Trial Evaluating the Safety, Tolerability, Efficacy and Pharmacokinetic Profile of Tacrolimus Inhalation Powder in Adult Lung Transplant Recipients

Sponsor
TFF Pharmaceuticals, Inc. (Industry)
Enrolment
14 enrolled
Conditions
Lung Transplant Rejection
Interventions
Tacrolimus Inhalation Powder; Plastiape RS00 Dry Powder inhaler device
Ages
adults, older adults
Registry
NCT05501574

Full record on ClinicalTrials.gov

From the registry

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 due to kidney toxicity. Tacrolimus Inhalation Powder is being developed as an alternative to oral tacrolimus for prevention of rejection in adult lung transplant recipients. 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 every 12 weeks 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.

Primary outcomes

  • Effect on renal function
  • Incidence of treatment-emergent AEs, serious adverse events (SAEs), and withdrawals due to AEs.
  • Change in systolic and diastolic blood pressure (mm Hg) over time
  • Changes from baseline in potassium (mEq/L) over time

History

  1. Last registry update

  2. Study completion

  3. Primary completion

  4. Started

  5. Registered