Phase Ⅳ Clinical Trial to Evaluate of Renamezin in Patients With Chronic Renal Failure.
This trial is active, not recruiting.
|Condition||chronic renal failure|
|Sponsor||Daewon Pharmaceutical Co., Ltd.|
|Start date||January 2016|
|End date||December 2016|
|Trial size||120 participants|
|Trial identifier||NCT02681991, RNM-001|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Renamezin capsule 2g, tid, PO
change from baseline of Indoxyl sulfate at 8weeks
time frame: 0, 8weeks
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
|Principal investigator||Hyeong-Cheon Park, Professor|
Call for more information