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Trial record 1 of 1 for:    NCT02681991
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Phase Ⅳ Clinical Trial to Evaluate of Renamezin in Patients With Chronic Renal Failure.

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ClinicalTrials.gov Identifier: NCT02681991
Recruitment Status : Completed
First Posted : February 15, 2016
Last Update Posted : July 6, 2017
Sponsor:
Information provided by (Responsible Party):
Hyeong-Cheon Park, Gangnam Severance Hospital

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.


Condition or disease Intervention/treatment Phase
Chronic Renal Failure Drug: Renamezin capsule Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Failure

Arm Intervention/treatment
Experimental: test
Renamezin capsule 2g, tid, PO
Drug: Renamezin capsule



Primary Outcome Measures :
  1. change from baseline of Indoxyl sulfate at 8weeks [ Time Frame: 0, 8weeks ]


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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02681991


Locations
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Korea, Republic of
Gangnam Sevrance Hospital of Yonsei University
Seoul, Gangnam-gu, Korea, Republic of, 06273
Sponsors and Collaborators
Daewon Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Hyeong-Cheon Park, Professor Gangnam Sevrance Hospital of Yonsei University
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Responsible Party: Hyeong-Cheon Park, Principal Investigator, Gangnam Severance Hospital
ClinicalTrials.gov Identifier: NCT02681991    
Other Study ID Numbers: RNM-001
First Posted: February 15, 2016    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases