A Study on the Effection of Potassium Citrate Extended-release Tablets on Urolithiasis Formation or Recurrence

Last updated: January 31, 2018
Sponsor: Dawnrays Pharmaceutical (Holdings) Limited
Overall Status: Active - Recruiting

Phase

4

Condition

Kidney Stones

Treatment

N/A

Clinical Study ID

NCT03007160
DAWNRAYS101
  • Ages 18-70
  • All Genders

Study Summary

Assess the efficacy and safety of potassium citrate extended-release tablets on Urolithiasis formation or recurrence.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with upper urinary tract calculi surgery and/or ESWL within 3 months;

  • Stone free or had residual stone fragments with a less than 4 mm diamete;

  • 18-70 years of age; the gender is not limited;

  • Agree to take effective contraceptive measures during the study period, and female ofchildbearing age whose pregnancy test is negative;

  • Subjects with no mental illness and language dysfunction, can understand the situationof the study and have signed informed consent.

Exclusion

Exclusion Criteria:

  • Patients with infectious stones, medical stones and urinary tract obstruction;

  • Patients with hyperkalemia (K+>5.5mmol/L) (or patients with factors or disease thatcan cause hyperkalemia), because the further increase in blood potassium can lead tocardiac arrest. These factors include disease or strenuous exercise, chronic renalfailure, uncontrolled diabetes, acute dehydration, excessive, adrenal insufficiency,extensive tissue failure. Patients who takes potassium sparing diuretics (such astriamterene, spironolactone, amiloride);

  • Patients with gastrointestinal disorders, such as peptic ulcer, severe vomiting,diarrhea, delayed gastric emptying, intestinal obstruction, etc.;

  • Combined with cardiovascular, liver, kidney, hematopoietic system, such as severeprimary disease, or known to affect the survival of serious diseases (such as canceror AIDS), or patients with with disabilities mentally or legally;

  • Patients with renal insufficiency (1.2 times the upper limit of the normal value ofserum creatinine and urea nitrogen);

  • The recent (within 6 months) with family planners;

  • Allergic to this product;

  • To participate in other clinical trials in the past three months.

Study Design

Total Participants: 2001
Study Start date:
July 01, 2016
Estimated Completion Date:
September 30, 2020

Study Description

This study takes "Rate of stone recurrence" as primary outcome measure, by random, blank control, and multicenter clinical trial design method, assess the efficacy and safety of potassium citrate extended-release tablets on Urolithiasis formation or recurrence, provide evidence for drug re-registration, and observe its efficacy on Urinary calculi such as renal tubular acidosis with calcium stone, and uric acid stones with or without calcium stone, urinary tract stone of effectiveness.

Connect with a study center

  • The Fifth Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan
    China

    Active - Recruiting

  • Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei 430030
    China

    Active - Recruiting

  • Wuhan No.1 Hospital(Wuhan Integrated TCM & Western Medicine Hospital)

    Wuhan, Hubei
    China

    Site Not Available

  • Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai
    China

    Active - Recruiting

  • Zhejiang Xiaoshan Hospital

    Hangzhou, Zhejiang
    China

    Active - Recruiting

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