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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00448071
Other study ID # MTR107IL-104
Secondary ID
Status Recruiting
Phase Phase 2
First received March 14, 2007
Last updated March 14, 2007
Start date May 2006
Est. completion date March 2007

Study information

Verified date December 2006
Source Wolfson Medical Center
Contact Zeev Katzir, MD
Phone 972-3-5028211
Is FDA regulated No
Health authority Israel: Ministry of HealthUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 12
Est. completion date March 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 75 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Intervention

Drug:
MTR107


Locations

Country Name City State
Israel Wolfson Medical Center Holon
Israel Asaf Harofeh Medical Center Rishon Le Zion

Sponsors (2)

Lead Sponsor Collaborator
Wolfson Medical Center Meditor Pharmaceuticals Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary A descriptive pharmacokinetic / pharmacodynamic study. No primary end-points apply.
Secondary Exploratory Efficacy Parameters:
Secondary ? Number and type of medical interventions required for treatment of hypotension.
Secondary ? Alleviation of symptoms associated with intradialytic hypotension.
Secondary ? Efficiency of dialysis as reflected by Kt/V
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