Clareo Health | 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
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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Daewon Pharmaceutical Co., Ltd.
Age
20–74
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
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
