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

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 Overview

• Status: Completed
• Conditions: Chronic Renal Failure
• Intervention / Treatment: Drug: Renamezin capsule; Drug: Kremezin granule

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seodaemun
    • Seoul, Seodaemun, Korea, Republic of, 03722
      • Sevrance Hospital of Yonsei University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Renamezin->Kremezin	Drug: Renamezin capsule; Drug: Kremezin granule
Active Comparator: Kremezin->Renamezin	Drug: Renamezin capsule; Drug: Kremezin granule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preference of formulation	questionnaire	24weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Creatinine		12weeks, 24weeks
Serum Indoxyl sulfate		12weeks, 24weeks
Cystatin-C		12weeks, 24weeks
estimated GFR(Glomerular Filtration Rate)	MDRD GFR	12weeks, 24weeks

Collaborators and Investigators

• Sponsor: Daewon Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Bumseok Kim, Professor, Sevrance Hospital of Yonsei University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: February 10, 2016
• First Submitted That Met QC Criteria: February 12, 2016
• First Posted (Estimate): February 15, 2016

Study Record Updates

• Last Update Posted (Actual): July 6, 2017
• Last Update Submitted That Met QC Criteria: July 4, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: DW_RNMZ_401