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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Hypotension, End Stage Renal Disease, Intra Dialytic Hypotension

Intervention / Treatment
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* Drug: MTR107


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MTR107|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A descriptive pharmacokinetic / pharmacodynamic study. No primary end-points apply. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypotension, End Stage Renal Disease, Intra Dialytic Hypotension, ESRD, Blood Pressure, Dialysis