A Phase 3 Study of Extended-release Tacrolimus in Subjects With Pulmonary Arterial Hypertension a… (NCT07612657) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Phase 3 Study of Extended-release Tacrolimus in Subjects With Pulmonary Arterial Hypertension and Functional Limitations
300 participantsStarted 2026-05-29
Plain-language summary
This study evaluates the effects of VI-0106 (an extended-release formulation of tacrolimus) in participants with pulmonary arterial hypertension (PAH) who continue to have functional limitations despite being on optimized background PAH therapy. Participants will be randomly assigned with equal chance to receive either VI-0106 or placebo in a double-blind fashion to assess whether VI-0106 improves outcomes in this population.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* WHO Group 1 PH: Pulmonary Arterial Hypertension;
* WHO functional class II - IV despite optimized treatment with one or more modalities. Treatments for PAH must be stable for at least 3 months at the time of screening;
* Right heart catheterization (RHC) at screening (or within 3 months prior to screening);
* Screening 6MWD \>75 meters to ≤450 meters.
Exclusion Criteria:
* PAH due to pulmonary veno-occlusive disease or pulmonary capillary hemangiomatosis
* Chronic thromboembolic or portopulmonary hypertension
* Total Lung Capacity (TLC) \<60% predicted;
* FEV1/FVC \<70% predicted or FEV1 \<60% predicted;
* Evidence of left-sided heart disease;
* Inability to safely attempt completion of the 6MWD;
* Life expectancy \<6 months;
* eGFR \<30 mL/min/1.73 m2 (CKD-EPI equation);
* Moderate to severe hepatic dysfunction (Child-Pugh score \>10);
* Serum potassium \>5.1 mEq/L;
* Use of experimental PAH treatments within the past 3 months;
* Active infection requiring antibiotic, antifungal, or antiviral therapies;
* Current systemic treatment with cyclosporine;
* Known allergy or hypersensitivity to tacrolimus;
* Significant psychiatric, addictive, or other disorder that compromises the subject's ability to provide informed consent, follow study protocol, or adhere to study treatment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in 6MWD (6 Minute Walk Distance) at Week 24