Overview

This trial is active, not recruiting.

Condition chronic renal failure
Treatment renamezin capsule
Phase phase 4
Sponsor Daewon Pharmaceutical Co., Ltd.
Start date January 2016
End date December 2016
Trial size 120 participants
Trial identifier NCT02681991, RNM-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Renamezin capsule 2g, tid, PO
renamezin capsule

Primary Outcomes

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

Eligibility Criteria

Male or female participants from 19 years up to 80 years old.

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

Additional Information

Principal investigator Hyeong-Cheon Park, Professor
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Daewon Pharmaceutical Co., Ltd..