Clinical trial NCT03007160: A Study on the Effection of Potassium Citrate Extended-release Tablets on Urolithiasis Formation or Recurrence
Official title: A Randomized, Blank Controlled, Multicenter Clinical Trial of the Effection of Potassium Citrate Extended-release Tablets on Urolithiasis Formation or Recurrence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Urolithiasis
Lead sponsor: Dawnrays Pharmaceutical (Holdings) Limited
Sponsor class: INDUSTRY
First posted: 2017-01-02
Enrollment: 2001
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Urolithiasis recurrence
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Time of stone recurrence
timeFrame: through study completion, an average of 1 year
measure: The changes of urine citric acid content compared with baseline
timeFrame: through study completion, an average of 1 year
measure: The changes of Urine pH value compared with baseline
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Fifth Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Zhengzhou
country: China
facility: The Second Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Wuhan No.1 Hospital（Wuhan Integrated TCM & Western Medicine Hospital）
state: Hubei
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Hangzhou
country: China
facility: Zhejiang Xiaoshan Hospital
state: Zhejiang
Study officials:
affiliation: Tongji Hospital
name: Zhangqun YE, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.
citation: 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.