Overview

This trial is active, not recruiting.

Condition chronic renal failure
Treatments renamezin capsule, kremezin granule
Phase phase 4
Sponsor Daewon Pharmaceutical Co., Ltd.
Start date December 2015
End date December 2016
Trial size 153 participants
Trial identifier NCT02681952, DW_RNMZ_401

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking open label
Arm
(Active Comparator)
renamezin capsule
kremezin granule
(Active Comparator)
renamezin capsule
kremezin granule

Primary Outcomes

Measure
Preference of formulation
time frame: 24weeks

Secondary Outcomes

Measure
Serum Creatinine
time frame: 12weeks, 24weeks
Serum Indoxyl sulfate
time frame: 12weeks, 24weeks
Cystatin-C
time frame: 12weeks, 24weeks
estimated GFR(Glomerular Filtration Rate)
time frame: 12weeks, 24weeks

Eligibility Criteria

Male or female participants from 20 years up to 74 years old.

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

Additional Information

Principal investigator Bumseok Kim, Professor
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Daewon Pharmaceutical Co., Ltd..