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

Chronic Renal Failure Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02681991
• Other study ID #: RNM-001
• Status: Completed
• Phase: Phase 4
• First received: February 10, 2016
• Last updated: July 4, 2017
• Start date: January 2016
• Est. completion date: September 2016

Study information

• Verified date: July 2017
• Source: Daewon Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Renal Failure
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• Renamezin capsule

Locations

Country	Name	City	State
Korea, Republic of	Gangnam Sevrance Hospital of Yonsei University	Seoul	Gangnam-gu

Sponsors (1)

Lead Sponsor	Collaborator
Daewon Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline of Indoxyl sulfate at 8weeks		0, 8weeks