Phase Ⅳ Clinical Trial to Evaluate of Renamezin in Patien... | NCT02681991

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

NCT02681991

Sponsor

Daewon Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Jul 6, 2017Actual

Enrollment

110Actual

Phase

Phase 4

Conditions

Chronic Renal Failure

Interventions

Renamezin capsule

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Sep 2016Actual

Completion Date

Sep 2016Actual

First Submitted Date

Feb 10, 2016

First Submission Date that Met QC Criteria

Feb 12, 2016

First Posted Date

Feb 15, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 4, 2017

Last Update Posted Date

Jul 6, 2017Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Label	Type	Description	Intervention Names
test	Experimental	Renamezin capsule 2g, tid, PO	Drug: Renamezin capsule

Name	Type	Description	Arm Group Labels	Other Names
Renamezin capsule	Drug		test

Measure	Description	Time Frame
change from baseline of Indoxyl sulfate at 8weeks		0, 8weeks

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases