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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-03-31

Brief Summary

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

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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.

Conditions

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Hypotension End Stage Renal Disease Intra Dialytic Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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MTR107

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No