Pharmacokinetic and Pharmacodynamic Effects of MTR107 in End-Stage Renal Disease (ESRD) Patients
Pharmacokinetic and Pharmacodynamic Effects of MTR107 in End-Stage Renal Disease (ESRD) Patients
MTR107 effect on blood pressure throught the dialysis procedure and its ability to prevent
 Intra dialytic Hypotension
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.
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.