Status:

UNKNOWN

Double-Blind, Placebo-Controlled Trial of Eefooton in Patients With Chronic Kidney Disease

Lead Sponsor:

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Collaborating Sponsors:

Morris Enterprise Co.,Ltd.

Conditions:

Chronic Kidney Diseases

Renal Insufficiency, Chronic

Eligibility:

All Genders

20-85 years

Phase:

NA

Brief Summary

This phase II study, 24-week, double-blind, study evaluated Eefooton's safety and efficacy for patients with CKD stage 3 to 4 Not on dialysis.

Detailed Description

The purpose of this clinical observation and research is to evaluate the eGFR changes in the renal function of patients with chronic kidney disease combination the Eefooton oral solution and commonly ...

Eligibility Criteria

Inclusion

  • Patients with chronic kidney disease who have signed the subject's consent and the glomerular filtration rate (eGFR) is less than 59ml/min/1.73m2
  • Both male and female patients aged 20-85 years old are acceptable
  • You must be able to come back at a specific time each month during the 6-month trial

Exclusion

  • Drug abuse.
  • Heart failure (stage 3-4)
  • Mental illness (psychotic disorder, epilepsy, depression, panic disorder)
  • Patients who have undergone dialysis or are expected to have a kidney transplant in the last three months
  • The blood pressure still exceeds 150/90mmHg after using more than three antihypertensive drugs
  • Pregnancy or planning to become pregnant or breastfeeding
  • Malignant disease
  • Acute illness (hepatitis, jaundice, acute myocardial infarction) in the last 3 months
  • The patient is engaged in another research study.
  • 3 months before entering the study or having used NSAIDs, anti-rejection drugs or performing imaging agent examinations during the study
  • You have participated in other research study in the previous month
  • You have drug dependence and drinking habits

Key Trial Info

Start Date :

March 1 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2024

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT05227313

Start Date

March 1 2022

End Date

December 31 2024

Last Update

March 2 2022

Active Locations (1)

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1

Department of Nephrology, Taipei Tzu Chi Hospital, Taipei, Taiwan

Taipei County, Taiwan