Overview

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

Status:
Completed
Trial end date:
2016-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Daewon Pharmaceutical Co., Ltd.
Criteria
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