CClinicalTrials.gg
Sign In
Status unknownNCT03007160Updated Feb 1, 2018

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

A Phase 4 interventional study of Potassium Citrate Extended-release Tablets in Urolithiasis, sponsored by Dawnrays Pharmaceutical (Holdings) Limited. Status unknown at 6 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-02-01.

Sponsored by Dawnrays Pharmaceutical (Holdings) Limited · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
2,001
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Urolithiasis
03

In context

Urolithiasis

278 studies on the registry are indexed under Urolithiasis; 70 are open to participants now.

This study's planned enrollment of 2,001 is above the median of 100 across 197 interventional studies indexed under Urolithiasis.

Browse Urolithiasis studies →

Lead sponsor

This is the only study on the registry with Dawnrays Pharmaceutical (Holdings) Limited as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,001 participants (estimated)

Study arms

  • Experimental
    Experimental group

    Potassium Citrate Extended-release Tablets

    Drug: Potassium Citrate Extended-release Tablets

  • No intervention
    Blank control group

    Subjects do not take the investigational product

Interventions

  • DrugPotassium Citrate Extended-release Tablets

    Daily 3.24g, Po ,Tid, each 1.08g/tablets

    Also known as: Juyuansuanjia Huanshi Pian

06

What researchers measure

Primary outcomes

  1. Rate of Urolithiasis recurrence

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. Time of stone recurrence

    Time frame: through study completion, an average of 1 year

  2. The changes of urine citric acid content compared with baseline

    Time frame: through study completion, an average of 1 year

  3. The changes of Urine pH value compared with baseline

    Time frame: through study completion, an average of 1 year

07

Study locations

5 of 6 sites recruiting
  • The Fifth Affiliated Hospital of Guangzhou Medical University
    Guangzhou, Guangdong, China
    • Dehui LAI · Contact · dehuilai@hotmail.com · (+86)13570508863
    • Yongzhong HE · Principal investigator
    • Dehui LAI · Sub investigator
    Recruiting
  • The Second Affiliated Hospital of Zhengzhou University
    Zhengzhou, Henan, China
    • Changwei LIU · Contact · lcw8001@126.com · (+86)13526709425
    • Changbao XU · Principal investigator
    • Changwei LIU · Sub investigator
    Recruiting
  • Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, Hubei 430030, China
    • Xiaolin GUO, M.D. · Contact · guoxiaolin0488@sina.com · (+86)13886042051
    • Zhangqun YE, M.D. · Principal investigator
    • Xiaolin GUO, M.D. · Sub investigator
    Recruiting
  • Wuhan No.1 Hospital（Wuhan Integrated TCM & Western Medicine Hospital）
    Wuhan, Hubei, China
    Active, not recruiting
  • Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine
    Shanghai, Shanghai, China
    • Mingxi XU · Contact · xuhuaneric@126.com · (+86)18221683312
    • Zhong WANG · Principal investigator
    • Mingxi XU · Sub investigator
    Recruiting
  • Zhejiang Xiaoshan Hospital
    Hangzhou, Zhejiang, China
    • Xing WANG · Contact · fly115135@sohu.com · (+86)18058806706
    • Yi FAN · Principal investigator
    • Xing WANG · Sub investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 25881654 ↗
  • 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. PubMed 12028622 ↗
  • 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. PubMed 10210371 ↗
  • 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. PubMed 20576821 ↗
  • 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. PubMed 17726345 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03007160
Lead sponsor
Dawnrays Pharmaceutical (Holdings) Limited
Responsible party
Sponsor
First posted
Jan 2, 2017
Start date
Jul 2016
Primary completion
Sep 2020 (estimated)
Completion
Sep 2020 (estimated)
Last update
Feb 1, 2018

Study contacts

Zhangqun YE, M.D.
Contact
zhangqun_ye@163.com
(+86)13507191761
Zhangqun YE, M.D.
principal investigator · Tongji Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Urolithiasis→

Start the discussion