Phase Ⅳ Clinical Trial to Evaluate of Renamezin in Patients With Chronic Renal Failure.

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-09-30

Brief Summary

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Renamezin Capsule (an oral adsorbent) lowers indoxyl sulfate levels in patient with chronic renal failure.

120 patients with chronic renal failure(baseline serum creatinine:1.5-5.0mg/dl).

Renamezin is administered 6.0mg/day. The treatment period is 2 months. The change in serum indoxyl sulfate will be evaluated.

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Detailed Description

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Conditions

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Chronic Renal Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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test

Renamezin capsule 2g, tid, PO

Group Type EXPERIMENTAL

Renamezin capsule

Intervention Type DRUG

Interventions

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Renamezin capsule

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. patients spontaneously written consent to participate in this clinical trial
2. men and women over age of 19
3. pre-dialysis patients with chronic renal failure stage patient for 3 months and patients for holding the stable state in serum creatinine 1.5mg/dl - 5.0mg/dl
4. patients who were no noticeable change for 12weeks before screening and are expected to change is not needed during therapy in the therapy of chronic renal failure(medication and dose -related, diet therapy)

Exclusion Criteria

1. patients with passes through the digestive tract disorders
2. patients with uncontrolled constipation symptoms
3. patients suffering from digestive tract ulcers and esophageal varices
4. patients with untreated severe hypertension (DBP ≥ 120mmHg)
5. patients hospitalized with angina pectoris, cardiovascular disease or diagnosed with serious arrhythmia or cerebrovascular disease within 6 months
6. patients with hepatic impairment (2 times greater than the upper limit of normal levels of AST, ALT)
7. subjects with dependency on alcohol
8. patients with current infections
9. pregnant women, nursing mothers
10. Patients with a possibility of pregnancy (However, negative case can be registered)
11. patients participating in another clinical trial in addition to the current clinical trial
12. Patient who do not fit the clinical trial participation the legal and mentally

Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No