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.
- patients spontaneously written consent to participate in this clinical trial
- men and women over age of 19
- 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
- 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)
- patients with passes through the digestive tract disorders
- patients with uncontrolled constipation symptoms
- patients suffering from digestive tract ulcers and esophageal varices
- patients with untreated severe hypertension (DBP ≥ 120mmHg)
- patients hospitalized with angina pectoris, cardiovascular disease or diagnosed with serious arrhythmia or cerebrovascular disease within 6 months
- patients with hepatic impairment (2 times greater than the upper limit of normal levels of AST, ALT)
- subjects with dependency on alcohol
- patients with current infections
- pregnant women, nursing mothers
- Patients with a possibility of pregnancy (However, negative case can be registered)
- patients participating in another clinical trial in addition to the current clinical trial
- Patient who do not fit the clinical trial participation the legal and mentally
|Principal investigator||Hyeong-Cheon Park, Professor|
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