A Multicenter, Randomized, Open-labeled, Cross-over, Acti... | NCT02681952

Studies
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

NCT02681952

Sponsor

Daewon Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Jul 6, 2017Actual

Enrollment

153Actual

Phase

Phase 4

Conditions

Chronic Renal Failure

Interventions

Renamezin capsule
Kremezin granule

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2015

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Feb 10, 2016

First Submission Date that Met QC Criteria

Feb 12, 2016

First Posted Date

Feb 15, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 4, 2017

Last Update Posted Date

Jul 6, 2017Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

153Actual

Label	Type	Description	Intervention Names
Renamezin->Kremezin	Active Comparator		Drug: Renamezin capsule Drug: Kremezin granule
Kremezin->Renamezin	Active Comparator		Drug: Renamezin capsule Drug: Kremezin granule

Name	Type	Description	Arm Group Labels	Other Names
Renamezin capsule	Drug		Kremezin->Renamezin Renamezin->Kremezin
Kremezin granule

Measure	Description	Time Frame
Preference of formulation	questionnaire	24weeks

Measure	Description	Time Frame
Serum Creatinine		12weeks, 24weeks
Serum Indoxyl sulfate		12weeks, 24weeks
Cystatin-C

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

74 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Bumseok Kim, Professor	Sevrance Hospital of Yonsei University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Sevrance Hospital of Yonsei University		Seoul	Seodaemun	03722	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33381933	Derived	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.

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms