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

Chronic Renal Failure Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02681952
• Other study ID #: DW_RNMZ_401
• Status: Completed
• Phase: Phase 4
• First received: February 10, 2016
• Last updated: July 4, 2017
• Start date: December 2015
• Est. completion date: December 2016

Study information

• Verified date: July 2017
• Source: Daewon Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Renal Failure
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• Renamezin capsule

• Kremezin granule

Locations

Country	Name	City	State
Korea, Republic of	Sevrance Hospital of Yonsei University	Seoul	Seodaemun

Sponsors (1)

Lead Sponsor	Collaborator
Daewon Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preference of formulation	questionnaire	24weeks
Secondary	Serum Creatinine		12weeks, 24weeks
Secondary	Serum Indoxyl sulfate		12weeks, 24weeks
Secondary	Cystatin-C		12weeks, 24weeks
Secondary	estimated GFR(Glomerular Filtration Rate)	MDRD GFR	12weeks, 24weeks