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Completed

NCT Number: NCT02681952

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

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Key information

Conditions

Chronic Renal Failure Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

20 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sevrance Hospital of Yonsei University

Seoul, Seodaemun, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Renamezin capsule

Drug

Kremezin granule

Drug

Primary outcomes

  1. Preference of formulation

    Time frame: 24weeks

    questionnaire

Secondary outcomes

  1. Serum Creatinine

    Time frame: 12weeks, 24weeks

  2. Serum Indoxyl sulfate

    Time frame: 12weeks, 24weeks

  3. Cystatin-C

    Time frame: 12weeks, 24weeks

  4. estimated GFR(Glomerular Filtration Rate)

    Time frame: 12weeks, 24weeks

    MDRD GFR

Sponsors and collaborators

Lead sponsor

Daewon Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 15, 2016
Registry last updated
Jul 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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