Revascularization of Stenosed Vessels Using Optimized Treatment of Rejuveinix for Reversing Endothelial Dysfunction

NCT03041259 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: RPI001
• Study Type: interventional
• Target: 320
• Locations: 0 countries
• Sites: N/A

Brief Summary

A Phase I/IIa Dose-Escalation Study Evaluating the Safety, Tolerability and Efficacy of Rejuveinix in Combination With Standard Interventional Therapy for Critical Limb Ischemia Patients with Rutherford Class 4, 5 and 6 Disease

Conditions

Critical Limb Ischemia; Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Number of Patients with Treatment-related Major Adverse Events as Defined by Re-intervention of the Target Vessel(s), Limb Amputation or Endovascular-related Death.

  MAE rates compared to an objective performance criterion (historical control). MAEs are defined as re-intervention of the target vessel(s), amputation of all or part of the target limb, or endovascular-related death.

  84 days

Secondary Outcomes (1)

• Change of Walking Impairment Questionnaire Score Measured at Day 1 and Day 84 in Rejuveinix Treated Patients

  84 days

Study Arms (2)

Rejuveinix Low Dose

EXPERIMENTAL

Intravenous dosing of two doses per week of Rejuveinix

Drug: Rejuveinix Low Dose

Rejuveinix High Dose

EXPERIMENTAL

Intravenous dosing of two doses per week of Rejuveinix

Drug: Rejuveinix High Dose

Interventions

Rejuveinix Low Dose DRUG

A intravenous administration of Rejuveinix after standard mechanical intervention of blocked peripheral artery

Also known as: RJX Low

Rejuveinix Low Dose

Rejuveinix High Dose DRUG

A intravenous administration of Rejuveinix after standard mechanical intervention of blocked peripheral artery

Also known as: RJX High

Rejuveinix High Dose

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject age \> 18 and \< 90 years of age.
• Subject has been informed of the nature of the study, agrees to participate and has signed an approved consent form.
• Subject understands the duration of the study, agrees to follow-up visits and the required testing.
• Subject has symptomatic lower extremity claudication (meets Rutherford category 4, 5, or 6).
• Subject has resting ankle-brachial index (ABI) \< 0.5, toe pressure \<50 mmHg, and/or other evidence suggesting severe PAD (ischemic ulceration, for example).
• No more than one-week post revascularization, defined as one of the following: PTA, Stent, or Atherectomy.
• Stenosis in the femoral, femoral-popliteal, popliteal, peroneal, tibial and/or pedal arteries.
• Angiographic or duplex ultrasound evidence of significant stenosis ≥ 50% DS of target lesion.
• Target treatment length from 1 to 25 cm (To include single or multifocal lesions within the target lesion segment.
• Reference vessel diameter (RVD) ≥ 3.5 mm and ≤ 7 mm.
• Not expected to require further interventional standard of care treatment during study participation (approximately 174 days).
• Anticipated life expectancy \>1 year.
• Has adequate hepatic function defined as total bilirubin \< 1.5 mg/dL, serum albumin \> 3.0 gm/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3.0 × upper limit of normal (ULN) or \< 5 x ULN for subjects with known hepatic metastases.
• Has adequate renal function defined as serum creatinine \< 2.5 × ULN.
• Has adequate bone marrow function defined as a hemoglobin ≥ 10 mg/dL, absolute neutrophil count (ANC) ≥ 1.5 × 109/L, and platelet count ≥ 100 × 109/L.

You may not qualify if:

• Inability to obtain informed consent.
• Pregnancy or suspected pregnancy during study period. Subjects of childbearing potential must a have negative pregnancy test ≤ 7 days prior to treatment.
• Recent diagnosis of cancer or treatment for cancer within last 12 months.
• Life expectancy \< 12 months.
• CVA \< 1 month prior to screening or any CVA resulting in unresolved walking impairment.
• STEMI Myocardial infarction \< 1 month prior to procedure.
• Contraindication to contrast media or any study-required medication.
• Coagulopathy or clotting disorders.
• Suspected systemic infection affecting target limb.
• Serum creatinine ≥ 2.5 mg/dL unless dialysis-dependent.
• Enrollment in a drug study or medical device investigational research study.
• Previous standard of care treatment to the same target lesion \< 3 months prior to study enrollment.
• Greater than 50% DS following treatment of inflow lesions in the iliac or common femoral artery.
• Unresolved complication following treatment of inflow lesions, or inflow lesion requiring a stent graft or surgical intervention.
• Grade 4 or grade 5 stent fracture affecting target stent or proximal to the target stent.

Sponsors & Collaborators

• Reven Pharmaceuticals, Inc.: lead

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Peripheral Arterial Disease

Interventions

ascorbic acid, magnesium sulfate heptahydrate, cyanocobalamin, thiamine hydrochloride, riboflavin 5' phosphate, niacinamide, pyridoxine hydrochloride, and calcium D-pantothenate drug combination

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2017
• First Posted: February 2, 2017
• Study Start: January 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: July 1, 2022
• Last Updated: August 9, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share