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CompletedNCT02681952Updated Jul 6, 2017

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 Phase 4 interventional study of Renamezin capsule and Kremezin granule in Chronic Renal Failure, sponsored by Daewon Pharmaceutical Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 74 Years. Per ClinicalTrials.gov, last updated 2017-07-06.

Sponsored by Daewon Pharmaceutical Co., Ltd. · Phase 4, Interventional, and Other

Phase
Phase 4
Study type
Interventional
Enrollment
153
Allocation
Randomized
Ages
20 Years to 74 Years
Sex
All
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Study 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

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Conditions studied

  • Chronic Renal Failure
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In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's enrollment of 153 is above the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

Daewon Pharmaceutical Co., Ltd. is the lead sponsor of 48 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
153 participants (actual)

Study arms

  • Active comparator
    Renamezin->Kremezin

    Drug: Renamezin capsule · Drug: Kremezin granule

  • Active comparator
    Kremezin->Renamezin

    Drug: Renamezin capsule · Drug: Kremezin granule

Interventions

  • DrugRenamezin capsule
  • DrugKremezin granule
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What researchers measure

Primary outcomes

  1. Preference of formulation

    questionnaire

    Time frame: 24weeks

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)

    MDRD GFR

    Time frame: 12weeks, 24weeks

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Study locations

1 site
  • Sevrance Hospital of Yonsei University
    Seoul, Seodaemun 03722, Korea, Republic of
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References and documents

Publications

  • Kee YK, Han SY, Kang DH, Noh JW, Jeong KH, Kim GH, Kim YW, Kim BS. Comparison of Different Types of Oral Adsorbent Therapy in Patients with Chronic Kidney Disease: A Multicenter, Randomized, Phase IV Clinical Trial. Yonsei Med J. 2021 Jan;62(1):41-49. doi: 10.3349/ymj.2021.62.1.41. PubMed 33381933 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02681952
Lead sponsor
Daewon Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Feb 15, 2016
Start date
Dec 2015
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Jul 6, 2017

Study contacts

Bumseok Kim, Professor
principal investigator · Sevrance Hospital of Yonsei University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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