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

Primary Purpose

Hypotension, End Stage Renal Disease, Intra Dialytic Hypotension

Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
MTR107
Sponsored by
Wolfson Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypotension focused on measuring Hypotension, End Stage Renal Disease, Intra Dialytic Hypotension, ESRD, Blood Pressure, Dialysis

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Wolfson Medical CenterRecruiting
  • Asaf Harofeh Medical CenterRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 14, 2007
Last Updated
March 14, 2007
Sponsor
Wolfson Medical Center
Collaborators
Meditor Pharmaceuticals Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00448071
Brief Title
Pharmacokinetic and Pharmacodynamic Effects of MTR107 in End-Stage Renal Disease (ESRD) Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2006
Overall Recruitment Status
Unknown status
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Wolfson Medical Center
Collaborators
Meditor Pharmaceuticals Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension, End Stage Renal Disease, Intra Dialytic Hypotension
Keywords
Hypotension, End Stage Renal Disease, Intra Dialytic Hypotension, ESRD, Blood Pressure, Dialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
12 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
MTR107
Primary Outcome Measure Information:
Title
A descriptive pharmacokinetic / pharmacodynamic study. No primary end-points apply.
Secondary Outcome Measure Information:
Title
Exploratory Efficacy Parameters:
Title
 Number and type of medical interventions required for treatment of hypotension.
Title
 Alleviation of symptoms associated with intradialytic hypotension.
Title
 Efficiency of dialysis as reflected by Kt/V

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 20-75 years, inclusive. 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. ECG performed up to one month before study start. 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) Normal coagulation status at study entry as judged by PT-INR, 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: Uncontrolled hypertension >140/90 mmHg. Unstable angina. Abnormal ECG which may indicate acute disease Variable weight gains. Mental retardation. Pregnancy. Malignancy or other concomitant serious diseases. Current participation in another clinical trial involving an investigational drug/device, or participation in such a trial within the last 30 days.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zeev Katzir, MD
Phone
972-3-5028211
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeev Katzir, MD
Organizational Affiliation
Wolfson Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shay Efrati, MD
Organizational Affiliation
Asaf Harofeh Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wolfson Medical Center
City
Holon
ZIP/Postal Code
58100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zeev Katzir, MD
Phone
972-3-5028291
Email
katzir@wolfson.health.gov.il
First Name & Middle Initial & Last Name & Degree
Zeev Katzir, MD
Facility Name
Asaf Harofeh Medical Center
City
Rishon Le Zion
ZIP/Postal Code
70300
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shay Efrati, MD
Phone
972-8-9778061
First Name & Middle Initial & Last Name & Degree
Shay Efrati, MD

12. IPD Sharing Statement

Learn more about this trial

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

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