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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02681991

Enrollment

110

Registered

2016-02-15

Start date

2016-01-31

Completion date

2016-09-30

Last updated

2017-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Renal Failure

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.

Interventions

DRUGRenamezin capsule

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
change from baseline of Indoxyl sulfate at 8weeks	0, 8weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026