Pharmacokinetics and Pharmacodynamics of MTR105 in Hypotensive Cardiac Surgery Patients

A Phase II, Randomized, Double Blind, Placebo-controlled, Dose-escalating Study to Assess the Pharmacokinetics and Pharmacodynamics of MTR105 in Cardiac Surgery Induced Hypotension Patients During Weaning Off Cardiopulmonary Bypass

The purpose of this study is to evaluate the safety, pharmacokinetic and the pharmacodynamic effects of escalating doses of MTR105 while weaning from bypass in a hypotensive population of cardiac surgery patients.

Study Overview

• Status: Withdrawn
• Conditions: Hypotension; Cardiopulmonary Bypass
• Intervention / Treatment: Drug: MTR105

Detailed Description

The study is a prospective, randomized, four-arm, dose-escalating, double blind, placebo controlled study evaluating the safety, pharmacokinetics, and pharmacodynamics of four dose levels of MTR105 in patients undergoing cardiac surgery utilizing cardiopulmonary bypass presenting hypotension upon weaning off bypass.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men or women age 18 years or older
• Referred for cardiac surgery requiring the use of CPB.
• Elective or urgent surgeries (non emergency operations).
• LVEF ≥40 based on cardiac catheterization results
• Normal renal function at study entry
• Normal hepatic function (within normal laboratory ranges) at study entry
• Normal coagulation status at study entry as judged by PT, PTT, fibrinogen and platelet count.
• Willingness to participate in the study and adhere to the study design.
• Willingness to sign an informed consent form.

Exclusion Criteria:

• Emergency operation
• Pulmonary hypertension (PA systolic pressure >60 mmHg)
• Ejection fraction less than 35% during weaning from bypass or cardiac index of less than 1.8
• Neurological events such as prior CVA, TIA or symptomatic carotid stenosis within 1 year of presenting for surgery
• Body weight <40 Kg
• Pregnancy
• Malignancy within 1 year of presenting for surgery
• Systemic infection as evidenced by elevated WBC or fever >38.5 C
• Usage of vasoactive medications within 24 hours except short term use of a vasoconstrictor during induction.
• Participation in any other investigational drug or device study within 30 days of randomization

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 1; Dose level 0.3 mg/kg with 6 active and 2 placebo	Drug: MTR105; Intravenous administration, dose escalating (4 arms), single dose
Other: 2; Dose level 0.6 mg/kg 6 patients active and 2 placebo	Drug: MTR105; Intravenous administration, dose escalating (4 arms), single dose
Other: 3; Dose level 1.2 mg/kg 6 active and 2 placebo	Drug: MTR105; Intravenous administration, dose escalating (4 arms), single dose
Other: 4; Dose level 2.4 mg/kg 6 active and 2 placebo	Drug: MTR105; Intravenous administration, dose escalating (4 arms), single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hemodynamic parameters	24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics	10 hours

Collaborators and Investigators

• Sponsor: Meditor Pharmaceuticals Ltd.
• Investigators: Principal Investigator: Penny Sappington, MD, University of Pittsburgh Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: June 1, 2007
• First Submitted That Met QC Criteria: June 1, 2007
• First Posted (Estimate): June 5, 2007

Study Record Updates

• Last Update Posted (Estimate): April 7, 2015
• Last Update Submitted That Met QC Criteria: April 6, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: MTR-105-US-102