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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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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

153 participants in 2 patient groups

Renamezin->Kremezin
Active Comparator group
Treatment:
Drug: Renamezin capsule
Drug: Kremezin granule
Kremezin->Renamezin
Active Comparator group
Treatment:
Drug: Renamezin capsule
Drug: Kremezin granule

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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