NCT02681952

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 15, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 6, 2017

Status Verified

July 1, 2017

Enrollment Period

1 year

First QC Date

February 10, 2016

Last Update Submit

July 4, 2017

Conditions

Chronic Renal Failure

Outcome Measures

Primary Outcomes (1)

  • Preference of formulation

    questionnaire

    24weeks

Secondary Outcomes (4)

  • Serum Creatinine

    12weeks, 24weeks

  • Serum Indoxyl sulfate

    12weeks, 24weeks

  • Cystatin-C

    12weeks, 24weeks

  • estimated GFR(Glomerular Filtration Rate)

    12weeks, 24weeks

Study Arms (2)

Renamezin->Kremezin

ACTIVE COMPARATOR
Drug: Renamezin capsuleDrug: Kremezin granule

Kremezin->Renamezin

ACTIVE COMPARATOR
Drug: Renamezin capsuleDrug: Kremezin granule

Interventions

Renamezin capsuleDRUG
Kremezin->RenamezinRenamezin->Kremezin
Kremezin granuleDRUG
Kremezin->RenamezinRenamezin->Kremezin

Eligibility Criteria

Age20 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sevrance Hospital of Yonsei University

Seoul, Seodaemun, 03722, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 33381933DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bumseok Kim, Professor

    Sevrance Hospital of Yonsei University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2016

First Posted

February 15, 2016

Study Start

December 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

July 6, 2017

Record last verified: 2017-07

Locations

KR(1)