A Study on the Effection of Potassium Citrate Extended-release Tablets on Urolithiasis Formation or Recurrence
NCT ID: NCT03007160
Last Updated: 2018-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
2001 participants
INTERVENTIONAL
2016-07-31
2020-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effective of Potassium Sodium Hydrogen Citrate in Treating Uric Acid Stones Using Gut Microbiota and Metabolomics.
NCT06118320
Efficacy of Potassium Sodium Hydrogen Citrate Therapy on Renal Stone Recurrence and/or Residual Fragments After Shockwave Lithotripsy and Percutaneous Nephrolithotomy in Calcium Oxalate Urolithiasis
NCT01329042
Effect of Composition and Timing of Ingestion of Fluids on the Urinary Excretion of Lithogenic Substances
NCT03447847
Hydroxycitrate: A Novel Therapy for Calcium Phosphate Urinary Stones
NCT06003348
Study of the Administration of a Food Supplement in Patients With Lithiasis Treated With Extracorporeal Shock Wave Lithotripsy.
NCT05525130
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental group
Potassium Citrate Extended-release Tablets
Potassium Citrate Extended-release Tablets
Daily 3.24g, Po ,Tid, each 1.08g/tablets
Blank control group
Subjects do not take the investigational product
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Potassium Citrate Extended-release Tablets
Daily 3.24g, Po ,Tid, each 1.08g/tablets
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dawnrays Pharmaceutical (Holdings) Limited
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Zhangqun YE, M.D.
Role: PRINCIPAL_INVESTIGATOR
Tongji Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 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
Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Zhejiang Xiaoshan Hospital
Hangzhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DAWNRAYS101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.