search
Back to results

A Multicenter, Randomized, Open-labeled, Cross-over, Active-controlled, Phase IV Clinical Trial to Evaluate the Preference of Formulation and the Efficacy and Safety of Renamezin and Kremezin in Pre-dialysis Patients With Chronic Renal Failure

Primary Purpose

Chronic Renal Failure

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Renamezin capsule
Kremezin granule
Sponsored by
Daewon Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Renal Failure

Eligibility Criteria

20 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • pre-dialysis patients with chronic renal failure stage
  • patient for holding the stable state in serum creatinine 2.0mg/dl - 5.0mg/dl of MDRD GFR 15-60ml/min/1.73m2 for 3 months before screening
  • patients haven't experienced dose spherical carbon adsorbent for 3months before screening
  • patients who were no noticeable change for 4weeks before screening and are expected to change is not needed during therapy in the therapy of chronic renal failure(type of blood pressure medication and dose -related, diet therapy)
  • patients spontaneously written consent to participate in this clinical trial

Exclusion Criteria:

  • patients with passes through the digestive tract disorders
  • patients with uncontrolled constipation symptoms
  • kidney transplant patients
  • patients who are taking immunosuppressive drugs
  • patients suffering from digestive tract ulcers and esophageal varices
  • patients with uncontrolled hypertension
  • patients hospitalized with cardiovascular disease within 3 months of the screening
  • patients with current infections
  • patients who do not fulfill therapies of chronic renal failure (taking medicine and diet) as appropriate
  • patients with hepatic impairment (2.5 times greater than the upper limit of normal levels of AST, ALT)
  • uncontrolled diabetes (HbA1c > 10 % or a fasting glucose > 180mg / dL)
  • patients with malignant tumors (However, if you do not relapse within five years after completion of therapy can be registered)
  • pregnant women, nursing mothers
  • those who do not agree to a contraceptive method allowed for the possibility of pregnancy in women
  • patients participating in another clinical trial in addition to the current clinical trial
  • subjects with dependency on drugs or alcohol
  • subjects who took any other investigational drugs within 30 days before participating this clinical trial study
  • patients expected to starting the dialysis within three months
  • other patients deemed unsuitable tester

Sites / Locations

  • Sevrance Hospital of Yonsei University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Renamezin->Kremezin

Kremezin->Renamezin

Arm Description

Outcomes

Primary Outcome Measures

Preference of formulation
questionnaire

Secondary Outcome Measures

Serum Creatinine
Serum Indoxyl sulfate
Cystatin-C
estimated GFR(Glomerular Filtration Rate)
MDRD GFR

Full Information

First Posted
February 10, 2016
Last Updated
July 4, 2017
Sponsor
Daewon Pharmaceutical Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT02681952
Brief Title
A Multicenter, Randomized, Open-labeled, Cross-over, Active-controlled, Phase IV Clinical Trial to Evaluate the Preference of Formulation and the Efficacy and Safety of Renamezin and Kremezin in Pre-dialysis Patients With Chronic Renal Failure
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewon Pharmaceutical Co., Ltd.

4. Oversight

5. Study Description

Brief Summary
A Multicenter, Randomized, Open-labeled, Cross-over, Active-controlled, Phase IV Clinical Trial to Evaluate the Preference of Formulation and the Efficacy and Safety of Renamezin and Kremezin in Pre-dialysis Patients With Chronic Renal Failure

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Failure

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
153 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Renamezin->Kremezin
Arm Type
Active Comparator
Arm Title
Kremezin->Renamezin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Renamezin capsule
Intervention Type
Drug
Intervention Name(s)
Kremezin granule
Primary Outcome Measure Information:
Title
Preference of formulation
Description
questionnaire
Time Frame
24weeks
Secondary Outcome Measure Information:
Title
Serum Creatinine
Time Frame
12weeks, 24weeks
Title
Serum Indoxyl sulfate
Time Frame
12weeks, 24weeks
Title
Cystatin-C
Time Frame
12weeks, 24weeks
Title
estimated GFR(Glomerular Filtration Rate)
Description
MDRD GFR
Time Frame
12weeks, 24weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: pre-dialysis patients with chronic renal failure stage patient for holding the stable state in serum creatinine 2.0mg/dl - 5.0mg/dl of MDRD GFR 15-60ml/min/1.73m2 for 3 months before screening patients haven't experienced dose spherical carbon adsorbent for 3months before screening patients who were no noticeable change for 4weeks before screening and are expected to change is not needed during therapy in the therapy of chronic renal failure(type of blood pressure medication and dose -related, diet therapy) patients spontaneously written consent to participate in this clinical trial Exclusion Criteria: patients with passes through the digestive tract disorders patients with uncontrolled constipation symptoms kidney transplant patients patients who are taking immunosuppressive drugs patients suffering from digestive tract ulcers and esophageal varices patients with uncontrolled hypertension patients hospitalized with cardiovascular disease within 3 months of the screening patients with current infections patients who do not fulfill therapies of chronic renal failure (taking medicine and diet) as appropriate patients with hepatic impairment (2.5 times greater than the upper limit of normal levels of AST, ALT) uncontrolled diabetes (HbA1c > 10 % or a fasting glucose > 180mg / dL) patients with malignant tumors (However, if you do not relapse within five years after completion of therapy can be registered) pregnant women, nursing mothers those who do not agree to a contraceptive method allowed for the possibility of pregnancy in women patients participating in another clinical trial in addition to the current clinical trial subjects with dependency on drugs or alcohol subjects who took any other investigational drugs within 30 days before participating this clinical trial study patients expected to starting the dialysis within three months other patients deemed unsuitable tester
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bumseok Kim, Professor
Organizational Affiliation
Sevrance Hospital of Yonsei University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sevrance Hospital of Yonsei University
City
Seoul
State/Province
Seodaemun
ZIP/Postal Code
03722
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
33381933
Citation
Kee YK, Han SY, Kang DH, Noh JW, Jeong KH, Kim GH, Kim YW, Kim BS. Comparison of Different Types of Oral Adsorbent Therapy in Patients with Chronic Kidney Disease: A Multicenter, Randomized, Phase IV Clinical Trial. Yonsei Med J. 2021 Jan;62(1):41-49. doi: 10.3349/ymj.2021.62.1.41.
Results Reference
derived

Learn more about this trial

A Multicenter, Randomized, Open-labeled, Cross-over, Active-controlled, Phase IV Clinical Trial to Evaluate the Preference of Formulation and the Efficacy and Safety of Renamezin and Kremezin in Pre-dialysis Patients With Chronic Renal Failure

We'll reach out to this number within 24 hrs