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

End Stage Renal Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00448071
• Other study ID #: MTR107IL-104
• 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
• 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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Hypotension
• Intra Dialytic Hypotension
• Kidney Diseases
• Kidney Failure, Chronic

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