FK506 (Tacrolimus) in Pulmonary Arterial Hypertension

ClinicalTrials.gov ID: NCT01647945

Public ClinicalTrials.gov record NCT01647945. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

Single-Center Randomized Controlled Phase II Study of Safety and Efficacy of FK-506 (Tacrolimus) in Pulmonary Arterial Hypertension

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Mutations in bone morphogenetic protein receptor 2 (BMPR2) are present in \>80% of familial and \~20% of sporadic pulmonary arterial hypertension (PAH) patients. Furthermore dysfunctional BMP signaling is a general feature of pulmonary hypertension even in non-familial PAH. We therefore hypothesized that increasing BMP signaling might prevent and reverse the disease. We screened \> 3500 FDA approved drugs for their propensity to increase BMP signaling and found FK506 (Tacrolimus) to be a strong activator of BMP signaling. Tacrolimus restored normal function of pulmonary artery endothelial cells, prevented and reversed experimental PAH in mice and rats. Given that Tacrolimus is already FDA approved with a known side-effect profile, it is an ideal candidate drug to use in patients with pulmonary arterial hypertension. The aims of our trial are: 1. Establish the Safety of FK506 in patients with PAH. 2. Evaluate the Efficacy of FK506 in PAH 3. Identify ideal candidates for future FK506 phase III clinical trial.

Study identification

NCT ID: NCT01647945
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: Edda Spiekerkoetter; Other
Enrollment: 23 participants

Conditions and interventions

Conditions

Pulmonary Arterial Hypertension

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years to 70 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jun 30, 2012
Primary completion: Apr 30, 2014
Completion: Jul 31, 2014
Last update posted: Oct 4, 2016

2012 – 2014

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Stanford University	Stanford	California	94305	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01647945, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 4, 2016 · Synced Sep 17, 2026

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The complete protocol, eligibility criteria, and contact information for NCT01647945 live on ClinicalTrials.gov.

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