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

Primary Purpose

Chronic Renal Failure

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Renamezin capsule
Sponsored by
Daewon Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Renal Failure

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gangnam Sevrance Hospital of Yonsei University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

test

Arm Description

Renamezin capsule 2g, tid, PO

Outcomes

Primary Outcome Measures

change from baseline of Indoxyl sulfate at 8weeks

Secondary Outcome Measures

Full Information

First Posted
February 10, 2016
Last Updated
July 4, 2017
Sponsor
Daewon Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02681991
Brief Title
Phase Ⅳ Clinical Trial to Evaluate of Renamezin in Patients With Chronic Renal Failure.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Daewon Pharmaceutical Co., Ltd.

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
test
Arm Type
Experimental
Arm Description
Renamezin capsule 2g, tid, PO
Intervention Type
Drug
Intervention Name(s)
Renamezin capsule
Primary Outcome Measure Information:
Title
change from baseline of Indoxyl sulfate at 8weeks
Time Frame
0, 8weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients spontaneously written consent to participate in this clinical trial men and women over age of 19 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 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: patients with passes through the digestive tract disorders patients with uncontrolled constipation symptoms patients suffering from digestive tract ulcers and esophageal varices patients with untreated severe hypertension (DBP ≥ 120mmHg) patients hospitalized with angina pectoris, cardiovascular disease or diagnosed with serious arrhythmia or cerebrovascular disease within 6 months patients with hepatic impairment (2 times greater than the upper limit of normal levels of AST, ALT) subjects with dependency on alcohol patients with current infections pregnant women, nursing mothers Patients with a possibility of pregnancy (However, negative case can be registered) patients participating in another clinical trial in addition to the current clinical trial Patient who do not fit the clinical trial participation the legal and mentally
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyeong-Cheon Park, Professor
Organizational Affiliation
Gangnam Sevrance Hospital of Yonsei University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gangnam Sevrance Hospital of Yonsei University
City
Seoul
State/Province
Gangnam-gu
ZIP/Postal Code
06273
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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