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

NCT00448071 | Unknown Phase 2 DMC

• 1 other identifier: MTR107IL-104
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Hypotension; End Stage Renal Disease; Intra Dialytic Hypotension

Keywords

Hypotension; End Stage Renal Disease; Intra Dialytic Hypotension; ESRD; Blood Pressure; Dialysis

Outcome Measures

Primary Outcomes (1)

• A descriptive pharmacokinetic / pharmacodynamic study. No primary end-points apply.

Secondary Outcomes (4)

• Exploratory Efficacy Parameters:

•  Number and type of medical interventions required for treatment of hypotension.

•  Alleviation of symptoms associated with intradialytic hypotension.

•  Efficiency of dialysis as reflected by Kt/V

Interventions

MTR107 DRUG

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wolfson Medical Center: lead
• Meditor Pharmaceuticals Ltd.: collaborator

Study Sites (2)

Wolfson Medical Center

Holon, 58100, Israel

RECRUITING

Asaf Harofeh Medical Center

Rishon LeZiyyon, 70300, Israel

RECRUITING

MeSH Terms

Conditions

Hypotension; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zeev Katzir, MD

  Wolfson Medical Center

  PRINCIPAL INVESTIGATOR

• Shay Efrati, MD

  Asaf Harofeh Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zeev Katzir, MD

CONTACT

972-3-5028211

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: March 14, 2007
• First Posted: March 15, 2007
• Study Start: May 1, 2006
• Study Completion: March 1, 2007
• Last Updated: March 15, 2007

Record last verified: 2006-12

Locations

IL (2)