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OpenTrials
Completed

NCT Number: NCT02681991

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

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.

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Key information

Conditions

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

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Gangnam Sevrance Hospital of Yonsei University

Seoul, Gangnam-gu, 06273, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Renamezin capsule

Drug

Primary outcomes

  1. change from baseline of Indoxyl sulfate at 8weeks

    Time frame: 0, 8weeks

Sponsors and collaborators

Lead sponsor

Daewon Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 15, 2016
Registry last updated
Jul 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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