Pharmacokinetic and Pharmacodynamic Effects of MTR107 in End-Stage Renal Disease (ESRD) Patients

March 14, 2007 updated by: Wolfson Medical Center

A Phase II, Randomized Double Blind Placebo-Controlled, Dose Escalating Study to Determine Pharmacokinetic and Pharmacodynamic Effects of MTR107 in End-Stage Renal Disease (ESRD) Patients

MTR107 effect on blood pressure throught the dialysis procedure and its ability to prevent Intra dialytic Hypotension

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The present clinical trial aims to investigate and provide a more precise characterization of the pharmacokinetic and pharmacodynamic profile of MTR107 in a population of ESRD patients predisposed to developing intradialytic hypotension. The study is also designed as a dose esclating study aiming to assess MTR107 safety.

Study Type

Interventional

Enrollment

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Holon, Israel, 58100
        • Recruiting
        • Wolfson Medical Center
        • Contact:
        • Principal Investigator:
          • Zeev Katzir, MD
      • Rishon Le Zion, Israel, 70300
        • Recruiting
        • Asaf Harofeh Medical Center
        • Contact:
          • Shay Efrati, MD
          • Phone Number: 972-8-9778061
        • Principal Investigator:
          • Shay Efrati, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 20-75 years, inclusive.
  2. Presence of frequent bouts of hypotension defined as 3 or more intradialytic hypotensive events per month for the last six months prior to baseline, despite standard adjustments in dry weight.
  3. ECG performed up to one month before study start.

  4. Well-preserved hepatic function (within normal laboratory ranges) at study entry as judged by:

    • Serum Bilirubin (Total Bilirubin (direct and indirect) 0.3-1.0 mg/dL, and Direct Bilirubin 0.1-0.5 mg/dL)
    • Serum Albumin (>3.6 g/dL),
    • Serum aminotransferases (AST (0-37 U/L) and ALT (0-40 U/L)),
    • GGT (Gamma Glutamine Trans Peptidase)
  5. Normal coagulation status at study entry as judged by PT-INR, PTT, fibrinogen and platelet count.
  6. Willingness to participate in the study and adhere to the study design.
  7. Willingness to sign an informed consent form.

Exclusion Criteria:

  1. Uncontrolled hypertension >140/90 mmHg.
  2. Unstable angina.
  3. Abnormal ECG which may indicate acute disease
  4. Variable weight gains.
  5. Mental retardation.
  6. Pregnancy.
  7. Malignancy or other concomitant serious diseases.
  8. Current participation in another clinical trial involving an investigational drug/device, or participation in such a trial within the last 30 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
A descriptive pharmacokinetic / pharmacodynamic study. No primary end-points apply.

Secondary Outcome Measures

Outcome Measure
Exploratory Efficacy Parameters:
 Number and type of medical interventions required for treatment of hypotension.
 Alleviation of symptoms associated with intradialytic hypotension.
 Efficiency of dialysis as reflected by Kt/V

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wolfson Medical Center

Collaborators

Meditor Pharmaceuticals Ltd.

Investigators

  • Principal Investigator: Zeev Katzir, MD, Wolfson Medical Center
  • Principal Investigator: Shay Efrati, MD, Asaf Harofeh Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion

December 7, 2022

Study Completion

March 1, 2007

Study Registration Dates

First Submitted

March 14, 2007

First Submitted That Met QC Criteria

March 14, 2007

First Posted (Estimate)

March 15, 2007

Study Record Updates

Last Update Posted (Estimate)

March 15, 2007

Last Update Submitted That Met QC Criteria

March 14, 2007

Last Verified

December 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTR107IL-104

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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