Status:
UNKNOWN
Pharmacokinetic and Pharmacodynamic Effects of MTR107 in End-Stage Renal Disease (ESRD) Patients
Lead Sponsor:
Wolfson Medical Center
Collaborating Sponsors:
Meditor Pharmaceuticals Ltd.
Conditions:
Hypotension
End Stage Renal Disease
Eligibility:
All Genders
20-75 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00448071
Start Date
May 1 2006
End Date
March 1 2007
Last Update
March 15 2007
Active Locations (2)
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1
Wolfson Medical Center
Holon, Israel, 58100
2
Asaf Harofeh Medical Center
Rishon LeZiyyon, Israel, 70300