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

Phase 4

Completed

• Conditions: Chronic Renal Failure
• Interventions: Drug: Renamezin capsule; Drug: Kremezin granule

• Registration Number: NCT02681952
• Lead Sponsor: Daewon Pharmaceutical Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-02-10
• Study First Submitted QC: 2016-02-12
• Study First Posted: 2016-02-15
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-04
• Last Update Posted: 2017-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Renamezin->Kremezin	Renamezin capsule	-
Kremezin->Renamezin	Renamezin capsule	-
Renamezin->Kremezin	Kremezin granule	-
Kremezin->Renamezin	Kremezin granule	-

Primary Outcome Measures

Name	Time	Method
Preference of formulation	24weeks	questionnaire

Secondary Outcome Measures

Name	Time	Method
Serum Creatinine	12weeks, 24weeks
Serum Indoxyl sulfate	12weeks, 24weeks
Cystatin-C	12weeks, 24weeks
estimated GFR(Glomerular Filtration Rate)	12weeks, 24weeks	MDRD GFR

Trial Locations

Locations (1)

Sevrance Hospital of Yonsei University; 🇰🇷 Seoul, Seodaemun, Korea, Republic of