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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2006 by Wolfson Medical Center.
Recruitment status was:  Recruiting
Meditor Pharmaceuticals Ltd.
Information provided by:
Wolfson Medical Center Identifier:
First received: March 14, 2007
Last updated: NA
Last verified: December 2006
History: No changes posted
MTR107 effect on blood pressure throught the dialysis procedure and its ability to prevent Intra dialytic Hypotension

Condition Intervention Phase
End Stage Renal Disease
Intra Dialytic Hypotension
Drug: MTR107
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Wolfson Medical Center:

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

Estimated Enrollment: 12
Study Start Date: May 2006
Estimated Study Completion Date: March 2007
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.

Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00448071

Contact: Zeev Katzir, MD 972-3-5028211

Wolfson Medical Center Recruiting
Holon, Israel, 58100
Contact: Zeev Katzir, MD    972-3-5028291   
Principal Investigator: Zeev Katzir, MD         
Asaf Harofeh Medical Center Recruiting
Rishon Le Zion, Israel, 70300
Contact: Shay Efrati, MD    972-8-9778061      
Principal Investigator: Shay Efrati, MD         
Sponsors and Collaborators
Wolfson Medical Center
Meditor Pharmaceuticals Ltd.
Principal Investigator: Zeev Katzir, MD Wolfson Medical Center
Principal Investigator: Shay Efrati, MD Asaf Harofeh Medical Center
  More Information Identifier: NCT00448071     History of Changes
Other Study ID Numbers: MTR107IL-104
Study First Received: March 14, 2007
Last Updated: March 14, 2007

Keywords provided by Wolfson Medical Center:
End Stage Renal Disease
Intra Dialytic Hypotension
Blood Pressure

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Vascular Diseases
Cardiovascular Diseases processed this record on May 23, 2017