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7.5 mg R2R01 for Heart Failure

Phase 2

Waitlist Available

Research Sponsored by River 2 Renal Corp.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female ≥ 18 years of age at screening

Willing to self-administer all SC injections

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 7, day 30

Awards & highlights

Study Summary

This trial will test if adding a new medication, R2R01, to the standard treatment for worsening heart failure is safe, well-tolerated, and effective when compared to the standard treatment alone

Who is the study for?

Adults with worsening heart failure who have certain levels of NT-pro-BNP, show at least two symptoms like shortness of breath or swelling, and are on stable heart failure medication. They must be able to self-administer injections and stay in the clinic for 3 days. Exclusions include severe kidney problems, recent major surgery or stroke, specific types of cardiomyopathy, high blood pressure or fast heart rate at screening, low hemoglobin levels, known allergies to R2R01 or serelaxin, liver issues, pregnant/nursing women.Check my eligibility

What is being tested?

The trial is testing a new treatment called R2R01 combined with standard care (SOC) against SOC alone in outpatients with worsening heart failure. The goal is to see if adding R2R01 improves patient outcomes compared to just using the usual treatments for this condition.See study design

What are the potential side effects?

While not explicitly listed here, potential side effects may include reactions similar to other medications used in heart failure such as changes in blood pressure and kidney function; allergic reactions; fatigue; dizziness; gastrointestinal disturbances; and possible injection site reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am willing to give myself subcutaneous injections.

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I experience at least two symptoms like shortness of breath, swelling, or fatigue due to heart failure.

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My kidney function, measured by eGFR, is between 20 and 75 mL/min.

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I have had symptoms of heart failure.

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I can stay in the clinic for 3 days for monitoring.

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I was hospitalized for heart failure in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 7, day 30

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 7, day 30

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 7, day 30 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number and rate of patients with one or more TEAEs (treatment emergent AE's) and/or serious TEAEs as assessed by CTCAE v5.0.

Secondary outcome measures

Change from Baseline on NT-pro-BNP using descriptive and summary statistics by dose level at Day 7 and Day 30.

Change from baseline on Cystatin C and creatinine clearance using descriptive and summary statistics by dose level at Day 7 and Day 30.

Number of all-cause hospitalizations among patients using descriptive and summary statistics for change from baseline by dose level at Day 30.

+5 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: 7.5 mg R2R01Experimental Treatment1 Intervention

8 study subjects will receive 7.5 mg R2R01 once daily subcutaneous injection for 7 days.

Group II: 5.0 mg R2R01Experimental Treatment1 Intervention

8 study subjects will receive 5.0 mg R2R01 once daily subcutaneous injection for 7 days.

Group III: 10.0 mg R2R01Experimental Treatment1 Intervention

8 study subjects will receive 10.0 mg R2R01 once daily subcutaneous injection for 7 days.

Group IV: PlaceboPlacebo Group1 Intervention

8 study subjects will receive placebo once daily subcutaneous injection for 7 days.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

River 2 Renal Corp.Lead Sponsor

1 Previous Clinical Trials

95 Total Patients Enrolled

International HealthCare, LLCOTHER

1 Previous Clinical Trials

600 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for patient participation in this clinical trial?

"Information from clinicaltrials.gov indicates that this specific research endeavor, which was first listed on March 1st, 2024 and most recently updated on February 8th, 2024, is not actively seeking participants. Nonetheless, there are a considerable number of 756 alternative trials currently open for enrollment."

Answered by AI

Are multiple medical facilities in Canada involved in conducting this research study?

"Five active trial sites include Eastern Shore Research Institute in Fairhope, Amavita Research Services, LLC in Miami, and Jacksonville Center for Clinical Research."

Answered by AI

Has the Food and Drug Administration granted approval for 5.0 mg R2R01?

"Based on our evaluation, the safety rating for 5.0 mg R2R01 is determined to be a 2 as per Power's assessment in this Phase 2 trial. It signifies that there exists some evidence indicating its safety profile without substantial data confirming efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

To Evaluate the Safety, Tolerability and Efficacy of R2R01 Combined With SOC as Compared to SOC Alone in Outpatients With Worsening Heart Failure (WHF)

2024. "To Evaluate the Safety, Tolerability and Efficacy of R2R01 Combined With SOC as Compared to SOC Alone in Outpatients With Worsening Heart Failure (WHF)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06264310.

All > Congestive Heart Failure