UrolithiasisPhase 4NCT03007160
A Study on the Effection of Potassium Citrate Extended-release Tablets on Urolithiasis Formation or Recurrence
A Phase 4 study testing Potassium Citrate Extended-release Tablets in people with Urolithiasis, run by Dawnrays Pharmaceutical (Holdings) Limited at 6 sites in China.
Trial summary
Assess the efficacy and safety of potassium citrate extended-release tablets on Urolithiasis formation or recurrence. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Urolithiasis
- What is being tested?
- Potassium Citrate Extended-release Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,001 participants
- Where
- 6 sitesChina
- Study dates
- Jul 2016to Sep 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 5 recruiting
- Recruiting
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Dehui LAI, (+86)13570508863, dehuilai@hotmail.com
Yongzhong HE
- Recruiting
Zhejiang Xiaoshan Hospital
Hangzhou, Zhejiang
Xing WANG, (+86)18058806706, fly115135@sohu.com
Yi FAN
- Recruiting
Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Mingxi XU, (+86)18221683312, xuhuaneric@126.com
Zhong WANG
- Recruiting
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Xiaolin GUO, M.D., (+86)13886042051, guoxiaolin0488@sina.com
Zhangqun YE, M.D.
- Active, not recruiting
Wuhan No.1 Hospital（Wuhan Integrated TCM & Western Medicine Hospital）
Wuhan, Hubei
- Recruiting
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Changwei LIU, (+86)13526709425, lcw8001@126.com
Changbao XU
About this study
Official title: A Randomized, Blank Controlled, Multicenter Clinical Trial of the Effection of Potassium Citrate Extended-release Tablets on Urolithiasis Formation or Recurrence
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.
- Conditions
- Urolithiasis
- Being tested
- Potassium Citrate Extended-release Tablets
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potassium Citrate Extended-release TabletsDrug
Also called Juyuansuanjia Huanshi Pian
Daily 3.24g, Po ,Tid, each 1.08g/tablets
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Potassium Citrate Extended-release Tablets Receives: Drug: Potassium Citrate Extended-release Tablets |
| Blank control group | No intervention | Subjects do not take the investigational product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Urolithiasis recurrence
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Time of stone recurrence
Measured: through study completion, an average of 1 year
The changes of urine citric acid content compared with baseline
Measured: through study completion, an average of 1 year
The changes of Urine pH value compared with baseline
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startJul 2016
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,001 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dawnrays Pharmaceutical (Holdings) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhangqun YE, M.D., Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03007160
- Sponsor's protocol ID
- DAWNRAYS101
- Status last verified
- Jan 2018
- First submitted
- 13 Dec 2016
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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 25881654Soygur 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 12028622Lee 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 10210371Fabris 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 20576821Bartoletti 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blank Controlled, Multicenter Clinical Trial of the Effection of Potassium Citrate Extended-release Tablets on Urolithiasis Formation or Recurrence
- ClinicalTrials.gov ID
- NCT03007160
- Acronym / sponsor ID
- DAWNRAYS101
- Conditions
- Urolithiasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,001 participants (estimated)
- Lead sponsor
- Dawnrays Pharmaceutical (Holdings) LimitedIndustry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 2 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Potassium Citrate Extended-release TabletsPotassium Citrate Extended-release Tablets |
| Blank control group | No intervention | –Subjects do not take the investigational product |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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)；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Potassium Citrate Extended-release TabletsAlso: Juyuansuanjia Huanshi PianDaily 3.24g, Po ,Tid, each 1.08g/tablets | Drug | Experimental group |
Primary outcome
Rate of Urolithiasis recurrence
Time frame: through study completion, an average of 1 year
3 secondary outcomes
Time of stone recurrence
Time frame: through study completion, an average of 1 year
The changes of urine citric acid content compared with baseline
Time frame: through study completion, an average of 1 year
The changes of Urine pH value compared with baseline
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
- Background: PubMed 25881654Sfoungaristos 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.
- Background: PubMed 12028622Soygur 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.
- Background: PubMed 10210371Lee 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.
- Background: PubMed 20576821Fabris 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.
- Background: PubMed 17726345Bartoletti 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhangqun YE, M.D. principal investigator
Tongji Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Potassium Citrate Extended-release Tablets in people with Urolithiasis, run by Dawnrays Pharmaceutical (Holdings) Limited at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhangqun YE, M.D. ((+86)13507191761, zhangqun_ye@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Urolithiasis recurrence (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03007160, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2018.