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

• Status: Unknown status
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wolfson Medical Center
• Collaborator: Meditor Pharmaceuticals Ltd.

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.