Clinical trial NCT00448071: Pharmacokinetic and Pharmacodynamic Effects of MTR107 in End-Stage Renal Disease (ESRD) Patients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hypotension
End Stage Renal Disease
Intra Dialytic Hypotension
Keywords: Hypotension
End Stage Renal Disease
Intra Dialytic Hypotension
ESRD
Blood Pressure
Dialysis
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Meditor Pharmaceuticals Ltd.
First posted: 2007-03-15
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 developing intradialytic hypotension. The study is also designed as a dose esclating study aiming to assess MTR107 safety.

Eligibility 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.

Primary outcomes:
measure: A descriptive pharmacokinetic / pharmacodynamic study. No primary end-points apply.
Secondary outcomes:
measure: Exploratory Efficacy Parameters:
measure:  Number and type of medical interventions required for treatment of hypotension.
measure:  Alleviation of symptoms associated with intradialytic hypotension.
measure:  Efficiency of dialysis as reflected by Kt/V
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Wolfson Medical Center
city: Rishon Le Zion
country: Israel
facility: Asaf Harofeh Medical Center
Study officials:
affiliation: Wolfson Medical Center
name: Zeev Katzir, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asaf Harofeh Medical Center
name: Shay Efrati, MD
role: PRINCIPAL_INVESTIGATOR
References: