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

Urolithiasis Clinical Trial

Official title:

A Randomized, Blank Controlled, Multicenter Clinical Trial of the Effection of Potassium Citrate Extended-release Tablets on Urolithiasis Formation or Recurrence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03007160
• Other study ID #: DAWNRAYS101
• Status: Recruiting
• Phase: Phase 4
• First received: December 13, 2016
• Last updated: January 31, 2018
• Start date: July 2016
• Est. completion date: September 2020

Study information

• Verified date: January 2018
• Source: Dawnrays Pharmaceutical (Holdings) Limited
• Contact: Zhangqun YE, M.D.
• Phone: (+86)13507191761
• Email: zhangqun_ye[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2001
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Recurrence
• Urolithiasis

Intervention

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

Locations

Country	Name	City	State
China	The Fifth Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	Zhejiang Xiaoshan Hospital	Hangzhou	Zhejiang
China	Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	Wuhan No.1 Hospital(Wuhan Integrated TCM & Western Medicine Hospital)	Wuhan	Hubei
China	The Second Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Dawnrays Pharmaceutical (Holdings) Limited

Country where clinical trial is conducted

China, 

References & Publications (5)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Soygür T, Akbay A, Küpeli 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Urolithiasis recurrence		through study completion, an average of 1 year
Secondary	Time of stone recurrence		through study completion, an average of 1 year
Secondary	The changes of urine citric acid content compared with baseline		through study completion, an average of 1 year
Secondary	The changes of Urine pH value compared with baseline		through study completion, an average of 1 year