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

NCT02681991 | Completed Phase 4

• 1 other identifier: RNM-001
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Renal Failure

Outcome Measures

Primary Outcomes (1)

• change from baseline of Indoxyl sulfate at 8weeks

  0, 8weeks

Study Arms (1)

test

EXPERIMENTAL

Renamezin capsule 2g, tid, PO

Drug: Renamezin capsule

Interventions

Renamezin capsule DRUG

test

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Daewon Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Gangnam Sevrance Hospital of Yonsei University

Seoul, Gangnam-gu, 06273, South Korea

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hyeong-Cheon Park, Professor

  Gangnam Sevrance Hospital of Yonsei University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2016
• First Posted: February 15, 2016
• Study Start: January 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: July 6, 2017

Record last verified: 2017-07

Locations

KR (1)