UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061188 |
|---|---|
| Receipt number | R000069817 |
| Scientific Title | A Prospective Single-Arm Study of Sotatercept for Safe Discontinuation of Parenteral Prostacyclin Therapy: HEalth Outcomes and REmission in Low-Risk Pulmonary Arterial Hypertension |
| Date of disclosure of the study information | 2026/04/07 |
| Last modified on | 2026/04/07 21:53:20 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Prospective Single-Arm Study of Sotatercept for Safe Discontinuation of Parenteral Prostacyclin Therapy: HEalth Outcomes and REmission in Low-Risk Pulmonary Arterial Hypertension
Acronym
SPHERE trial
Scientific Title
A Prospective Single-Arm Study of Sotatercept for Safe Discontinuation of Parenteral Prostacyclin Therapy: HEalth Outcomes and REmission in Low-Risk Pulmonary Arterial Hypertension
Scientific Title:Acronym
A Prospective Single-Arm Study of Sotatercept for Safe Discontinuation of Parenteral Prostacyclin Therapy: HEalth Outcomes and REmission in Low-Risk Pulmonary Arterial Hypertension (SPHERE trial)
Region
| Japan |
Condition
Condition
pulmonary arterial hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is an exploratory, prospective study designed to investigate whether the gradual reduction and discontinuation of prostacyclin-based injectable medications can be safely implemented in PAH patients who have maintained a low-risk status (REVEAL Lite 2 score of 5 or less) for at least 3 months while receiving sotatercept.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of achieving non-worsening at 90 days after discontinuation of prostacyclin-based injectables.
1. No clinical events (death, PAH-related hospitalization, syncope, reintroduction of injectables, etc.)
2. Maintenance of REVEAL Lite 2: 5 or fewer than 5
3. No worsening on RHC:
PVR: Does not meet the criteria of an increase of 15% or more than 15% from baseline and 1 or more than 1 WU
CI: Does not decrease to less than 2.0 L/min/m2
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Reduction and discontinuation of continuous intravenous or subcutaneous administration of prostacyclin analogs during treatment with sotatercept
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Patients with a confirmed diagnosis of pulmonary arterial hypertension.
2 Patients are currently receiving two or more therapeutic agents, including prostacyclin analogue injectables, continuous intravenous, or continuous subcutaneous infusion.
3 Patients who have been on sotatercept for at least 3 months.
4 Patients who have maintained a low risk score for at least 3 months based on the REVEAL Lite 2 criteria.
5 Individuals who meet any of the following criteria, and for whom the continuation of injectable therapy clearly causes significant disadvantages in daily life.
Quality of life is clearly impaired due to pain, gastrointestinal symptoms, or other side effects of the injectable medication.
Individuals with a history of central venous catheter-related infection who are deemed to be at high risk of reinfection.
Carrying a pump or managing treatment at home significantly limits the patient's functional capacity.
Individuals who wish to discontinue prostacyclin analogue injectable therapy.
6 Individuals aged 18 years or older.
7 Individuals who understand the content of this study and can provide written consent.
Key exclusion criteria
1. Contraindications for sotatercept (history of hypersensitivity to the drug, platelet count <50,000/mm3)
2. Patients with mPAP >40 mmHg at enrollment
3. Patients who required hospitalization or intensified treatment for PAH within 3 months prior to enrollment
4. Patients with serious comorbidities (e.g., severe liver or kidney dysfunction, uncontrolled heart disease, or infections)
5. Women who are pregnant, breastfeeding, or planning to become pregnant during study participation
6. Cases where the principal investigator or a co-investigator determines that participation in this study is inappropriate
7. Patients with mPAP <25 mmHg and PAP/CO slope <3 (based on iCPET)
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takumi |
| Middle name | |
| Last name | Inami |
Organization
Kyorin University School of Medicine
Division name
Department of Cardiovascular Medicine,
Zip code
181-8611
Address
6-20-2, Shinkawa, Mitaka, Tokyo, Japan
TEL
0422-47-5511
tinami@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Takumi |
| Middle name | |
| Last name | Inami |
Organization
Kyorin University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
181-8611
Address
6-20-2, Shinakwa, Mitaka, Tokyo, Japan
TEL
0422-47-5511
Homepage URL
tinami@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University School of Medicine
Institute
Department
Personal name
Takumi Inami
Funding Source
Organization
not applicable
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
School of Medicine Research Ethics Committee, Kyorin University
Address
6-20-2, Shinkawa, Mitaka, Tokyo, Japan
Tel
0422-47-5511
rec@ks.kyorin-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 07 | Day |
Last modified on
| 2026 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069817
