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

Daewon Pharmaceutical

Status and phase

Completed

Phase 4

Conditions

Chronic Renal Failure

Treatments

Drug: Kremezin granule

Drug: Renamezin capsule

Study type

Interventional

Funder types

Industry

Identifiers

NCT02681952

DW_RNMZ_401

Details and patient eligibility

About

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

Enrollment

153 patients

Sex

All

Ages

20 to 74 years old

Volunteers

No Healthy Volunteers

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