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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by Wolfson Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Meditor Pharmaceuticals Ltd.
Information provided by:
Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT00448071
First received: March 14, 2007
Last updated: NA
Last verified: December 2006
History: No changes posted
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00448071

Contacts
Contact: Zeev Katzir, MD 972-3-5028211

Locations
Israel
Wolfson Medical Center Recruiting
Holon, Israel, 58100
Contact: Zeev Katzir, MD    972-3-5028291    katzir@wolfson.health.gov.il   
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.
Investigators
Principal Investigator: Zeev Katzir, MD Wolfson Medical Center
Principal Investigator: Shay Efrati, MD Asaf Harofeh Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00448071     History of Changes
Other Study ID Numbers: MTR107IL-104
Study First Received: March 14, 2007
Last Updated: March 14, 2007
Health Authority: Israel: Ministry of Health
United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Hypotension
Kidney Diseases
Kidney Failure, Chronic
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on July 26, 2014