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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03007160
Other study ID # DAWNRAYS101
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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