Trials / Active Not Recruiting
Active Not RecruitingNCT06092970
An Evaluation of Patient Reported Outcomes and Clinical Outcomes
Clinical Protocol REN-007E - Extension Study: An Evaluation of Patient Reported Outcomes and Clinical Outcomes Through 12 Months Post-Cardiac Surgery in Subjects Enrolled in Study REN-007
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 379 (actual)
- Sponsor
- Renibus Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This extension study is being conducted to assess the following objectives through 12 months post-cardiac surgery: * Patient reported outcomes (PRO), using the EQ-5D questionnaire * Clinical outcomes
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RBT-1 | Intravenous administration |
| DRUG | Placebo | Intravenous administration |
Timeline
- Start date
- 2023-10-16
- Primary completion
- 2026-06-30
- Completion
- 2026-06-30
- First posted
- 2023-10-23
- Last updated
- 2025-08-01
Locations
39 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06092970. Inclusion in this directory is not an endorsement.