A Study to Investigate the Safety and Efficacy of a Novel Furosemide Regimen

NCT02721511 | Withdrawn Phase 1

• 1 other identifier: HUM00107057
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a, prospective, single center, open-label, pilot study to evaluate the safety and efficacy of the subcutaneous administration of a novel furosemide formulation. The results of this pilot study will be reviewed to determine the safety of the subcutaneous treatment regimen and to evaluate patient selection criteria for possible at home treatment. The intent is to conduct a future follow on study looking at the feasibility of at home treatment of patients referred to a hospital for treatment of fluid overload.

Conditions

Acute Decompensated Heart Failure

Outcome Measures

Primary Outcomes (2)

• Efficacy endpoint: Urine output per 24 hours

  Efficacy will be measured as the ability of the diuretic regimen given one or two times daily to achieve a net 24 hour urine output of 3000 cc or more over the first 24 hours of the study.

  24 hours

• Safety endpoint: Composite of Severe hypokalemia, severe hyperkalemia, moderate to severe worsening of renal function, fever, sepsis, intravenous catheter infection, cardiac dysrhythmia causing syncope or requiring therapy or death

  Safety will be assessed as the composite of developing any of the pre-specified serious adverse events: Severe hypokalemia, severe hyperkalemia, moderate to severe worsening of renal function, fever, sepsis, intravenous catheter infection, cardiac dysrhythmia causing syncope or requiring therapy, death.

  24 hours

Secondary Outcomes (4)

• Functional Status

  24 hours

• Quality of life

  24 hours

• Congestion Scale

  24 hours

• Breathlessness

  24 hours

Study Arms (1)

Furosemide injection solution 8mg/mL

EXPERIMENTAL

8mg/mL (total dose=80mg) of furosemide injection solution administered subcutaneously as 30mg over the first hour and then as 12.5 mg per hours over the subsequent 4 hours.

Drug: Furosemide Injection Solution 8mg/mL

Interventions

Furosemide Injection Solution 8mg/mL DRUG

Furosemide Injection Solution, 8 mg/mL, (total dose =80 mg) administered subcutaneously as 30 mg over the first hour and then as 12.5 mg per hour over the subsequent 4 hours by means of the B. Braun Perfusor® Space Infusion Pump System.

Also known as: SCP-101, Buffered Lasix, Buffered furosemide

Furosemide injection solution 8mg/mL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or male 18 years or older
• History of heart failure \>90-days
• Presenting to the University of Michigan Health System because of evidence of fluid overload and recommended for admission or observation unit stay to receive intravenous (IV) furosemide therapy.
• Estimated excess fluid weight of 10 lbs or more from euvolemic state.
• Estimated jugular venous pressure (JVP) ≥ 10 cm above the right atrium (RA).
• Evidence of edema up to mid shin or higher
• Agreeing to sign informed consent and HIPAA authorization
• Daily dose of furosemide prescribed ≤ 160 mg, or torsemide ≤ 40 mg or bumetanide ≤ 4 mg.

You may not qualify if:

• Pregnant females or women of child-bearing age who are not willing to use an adequate form of contraception
• Chronic Obstructive Pulmonary Disease (COPD) moderate or worse: FEV1/FCV ratio \<0.7 and FEV1 \<60 percent predicted.
• Rapid atrial fibrillation (AF) (HR \>100b/min)
• Hypoxia (resting O2 saturation \<9%)
• Hypotension (systolic blood pressure (SBP) BP \< 90 mmHg)
• Uncontrolled diabetes mellitus (DM) (admission glucose levels \> 300 mg/dL)
• Advanced renal disease (eGFR \< 30mL/min/1.73m2)
• Hypoalbuminemia (Albumin \< 3.0 g/dL)
• Acute coronary syndrome
• Serum potassium (K+) \<3.5 meq/L or using potassium supplements equivalent to \> 80meq/day.
• \. On experimental medication or currently participating in cardiovascular research study.
• \. Urinary tract abnormality or disorder interfering with urination. 15. Allergy to the active and inactive ingredients of the study medication. 16. Inability to comply with study requirements 17. Dementia 18. Ongoing substance abuse

Sponsors & Collaborators

• Todd M Koelling, MD: lead
• scPharmaceuticals, Inc.: collaborator

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Study Officials

• Todd M Koelling, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Internal Medicine

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: March 29, 2016
• Study Start: May 1, 2016
• Primary Completion: March 7, 2017
• Study Completion: March 7, 2017
• Last Updated: March 24, 2017

Record last verified: 2017-03

Locations

US (1)