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

Phase 4

Completed

• Conditions: Chronic Renal Failure
• Interventions: Drug: Renamezin capsule

• Registration Number: NCT02681991
• Lead Sponsor: Daewon Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-02-10
• Study First Submitted QC: 2016-02-12
• Study First Posted: 2016-02-15
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-04
• Last Update Posted: 2017-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
test	Renamezin capsule	Renamezin capsule 2g, tid, PO

Primary Outcome Measures

Name	Time	Method
change from baseline of Indoxyl sulfate at 8weeks	0, 8weeks

Trial Locations

Locations (1)

Gangnam Sevrance Hospital of Yonsei University; 🇰🇷 Seoul, Gangnam-gu, Korea, Republic of