NCT07221513WithdrawnPhase 2
Study of JK07 in Patients With Heart Failure and WHO Group 2 Combined Post- and Pre-Capillary Pulmonary Hypertension
A Phase 2a, Open-Label Study to Assess the Safety, Tolerability, and Efficacy of JK07 in Participants With Heart Failure and Group 2 Combined Post-Capillary and Pre-Capillary Pulmonary Hypertension (RENEU-PH)
Source: ClinicalTrials.gov · Last updated 15 May 2026
Reason given: Sponsor decision
Brief summary (registry, in English)
This is a Phase 2a, open-label, multiple-dose study to assess the safety, tolerability, and efficacy of JK07 in participants 18 to 85 years of age with diagnosed HF and cpcPH. At least 20 and up to approximately 30 participants will be enrolled and receive JK07 high dose in this open-label trial.
- Status (registry)
- Withdrawn
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 20 Aug 2025
- Start date
- 15 Dec 2025
- Primary completion date
- 16 Apr 2026
- Lead sponsor
- Salubris Biotherapeutics Inc
- NCT number
- NCT07221513
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- A diagnosis of pre-existing lung disease including congenital abnormalities, full or partial pneumonectomy, or previous therapeutic radiation of lungs or mediastinum.
Other
- Diagnosis of PH in World Health Organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5.
- Contraindicated to RHC that can be left in place for approximately 6 hours.
- Body mass index (BMI) >45 kg/m² at screening.
Who the study is looking for
- Participants with HF New York Heart Association Class II-III.
- Participants will be classified as having HFrEF (LVEF ≤ 40%) or HFpEF (LVEF >40% and ≤70%).
- Right heart catheterization (RHC) based evidence of cpcPH:
- PVR ≥2.5 WU; AND
- mPAP ≥25 mmHg; AND
- PAWP ≥16 mmHg
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Saint Francis Heart and Vascular Institute | Tulsa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.