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

This study is currently recruiting participants.

Verified by Wolfson Medical Center, December 2006

First Received: March 14, 2007 No Changes Posted

Sponsors and Collaborators:	Wolfson Medical Center Meditor Pharmaceuticals Ltd.
Information provided by:	Wolfson Medical Center
ClinicalTrials.gov Identifier:	NCT00448071

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Pharmacokinetics/Dynamics Study
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:

MedlinePlus related topics: Low Blood Pressure

U.S. FDA Resources

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:

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.

Contacts and Locations

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

Study ID Numbers:	MTR107IL-104
Study First Received:	March 14, 2007
Last Updated:	March 14, 2007
ClinicalTrials.gov Identifier:	NCT00448071 History of Changes
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

Study placed in the following topic categories:

Hypotension
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

Vascular Diseases
Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

Hypotension
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Vascular Diseases

Kidney Failure, Chronic
Cardiovascular Diseases
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on September 02, 2009