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

Overview

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

Full Title of Study: “A Randomized, Blank Controlled, Multicenter Clinical Trial of the Effection of Potassium Citrate Extended-release Tablets on Urolithiasis Formation or Recurrence”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2020

Detailed 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.

Interventions

  • Drug: Potassium Citrate Extended-release Tablets
    • Daily 3.24g, Po ,Tid, each 1.08g/tablets

Arms, Groups and Cohorts

  • Experimental: Experimental group
    • Potassium Citrate Extended-release Tablets
  • No Intervention: Blank control group
    • Subjects do not take the investigational product

Clinical Trial Outcome Measures

Primary Measures

  • Rate of Urolithiasis recurrence
    • Time Frame: through study completion, an average of 1 year

Secondary Measures

  • Time of stone recurrence
    • Time Frame: through study completion, an average of 1 year
  • The changes of urine citric acid content compared with baseline
    • Time Frame: through study completion, an average of 1 year
  • The changes of Urine pH value compared with baseline
    • Time Frame: through study completion, an average of 1 year

Participating in This Clinical Trial

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 of childbearing age whose pregnancy test is negative; – Subjects with no mental illness and language dysfunction, can understand the situation of the study and have signed informed consent. 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 that can cause hyperkalemia), because the further increase in blood potassium can lead to cardiac arrest. These factors include disease or strenuous exercise, chronic renal failure, uncontrolled diabetes, acute dehydration, excessive, adrenal insufficiency, extensive tissue failure. Patients who takes potassium sparing diuretics (such as triamterene, 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 severe primary disease, or known to affect the survival of serious diseases (such as cancer or AIDS), or patients with with disabilities mentally or legally; – Patients with renal insufficiency (1.2 times the upper limit of the normal value of serum 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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Dawnrays Pharmaceutical (Holdings) Limited
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Zhangqun YE, M.D., Principal Investigator, Tongji Hospital
  • Overall Contact(s)
    • Zhangqun YE, M.D., (+86)13507191761, zhangqun_ye@163.com

References

Sfoungaristos S, Gofrit ON, Yutkin V, Pode D, Duvdevani M. Prevention of renal stone disease recurrence. A systematic review of contemporary pharmaceutical options. Expert Opin Pharmacother. 2015 Jun;16(8):1209-18. doi: 10.1517/14656566.2015.1037740. Epub 2015 Apr 16.

Soygur T, Akbay A, Kupeli S. Effect of potassium citrate therapy on stone recurrence and residual fragments after shockwave lithotripsy in lower caliceal calcium oxalate urolithiasis: a randomized controlled trial. J Endourol. 2002 Apr;16(3):149-52. doi: 10.1089/089277902753716098.

Lee YH, Huang WC, Tsai JY, Huang JK. The efficacy of potassium citrate based medical prophylaxis for preventing upper urinary tract calculi: a midterm followup study. J Urol. 1999 May;161(5):1453-7.

Fabris A, Lupo A, Bernich P, Abaterusso C, Marchionna N, Nouvenne A, Gambaro G. Long-term treatment with potassium citrate and renal stones in medullary sponge kidney. Clin J Am Soc Nephrol. 2010 Sep;5(9):1663-8. doi: 10.2215/CJN.00220110. Epub 2010 Jun 24.

Bartoletti R, Cai T, Mondaini N, Melone F, Travaglini F, Carini M, Rizzo M. Epidemiology and risk factors in urolithiasis. Urol Int. 2007;79 Suppl 1:3-7. doi: 10.1159/000104434.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.