Kidney CalculiPhase 4NCT01329042
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
A Phase 4 study testing Potassium-sodium citrate in people with Kidney Calculi, run by Ouiheng International Healthcare Co., Ltd.
Trial summary
Extracorporeal shock wave lithotripsy (ESWL) and Percutaneous nephrolithotomy (PCNL) become the therapy of choice for renal stone. Although providing good results, stone recurrence is usually found as the therapies do not change the underlying metabolic abnormality. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Calculi
- What is being tested?
- Potassium-sodium citrate
- Type of treatment
- Pill or oral medicine
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- May 2005to Feb 2008
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age > 18 years
- stone free or had residual calcium oxalate stone fragments with a less than 4 mm. diameter at eight weeks after ESWL or PCNL
Who cannot join
- renal tubular obstruction
- serum creatinine > 2 mg/dl
- urinary tract infection (bacteria > 100,000 in urine culture)
- hypersensitive or contraindication to Potassium sodium hydrogen citrate
- insertion Double-J Stent
- history of arrhythmia, myocardial infarction or digitalis administration
About this study
Extracorporeal shock wave lithotripsy (ESWL) and Percutaneous nephrolithotomy (PCNL) become the therapy of choice for renal stone. Although providing good results, stone recurrence is usually found as the therapies do not change the underlying metabolic abnormality. Among the metabolic disorders, hypocitraturia is an important risk factor for calcium nephrolithiasis. This study evaluate the preventive effects of potassium sodium citrate on stone recurrence as well as stone growth post ESWL or PCNL, in patients with calcium-containing stones.
- Conditions
- Kidney Calculi
- Being tested
- Potassium-sodium citrate
- Keywords
- Potassium sodium citrate, stone recurrence, ESWL, PCNL, Hypocitraturia, intervention
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potassium-sodium citrateDrug
Also called Uralyt-U
The treated group was given oral potassium-sodium citrate 81 mEq/day The control group received no treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of stone recurrence or stone growth
The patients were evaluated at 6 months after the initial treatment for serum chemistry and urinalysis. After 12 months, all patients were evaluated for serum chemistry, urinalysis, 24-hour urine study and plain KUB.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2011 (estimated)
- Study startMay 2005
- Primary completionOct 2007
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CalculiStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ouiheng International Healthcare Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chiang Mai University, Prince Songkla University, Chulalongkorn University, Siriraj Hospital
- Investigators
- Bannakij Lojanapiwat, MD, Principal investigator, Division of Urology, Department of Surgery, Chiangmai University, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01329042
- Sponsor's protocol ID
- UU01/47
- Status last verified
- Apr 2011
- First submitted
- 4 Apr 2011
- Last updated
- 5 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01329042
- Acronym / sponsor ID
- UU01/47
- Conditions
- Kidney Calculi
- Keywords
- Potassium sodium citrate, stone recurrence, ESWL, PCNL, Hypocitraturia, intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ouiheng International Healthcare Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Chiang Mai University, Prince Songkla University, Chulalongkorn University, Siriraj Hospital
- Study start
- May 2005
- Primary completion
- Oct 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 5 Apr 2011 (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.
Extracorporeal shock wave lithotripsy (ESWL) and Percutaneous nephrolithotomy (PCNL) become the therapy of choice for renal stone. Although providing good results, stone recurrence is usually found as the therapies do not change the underlying metabolic abnormality. Among the metabolic disorders, hypocitraturia is an important risk factor for calcium nephrolithiasis. This study evaluate the preventive effects of potassium sodium citrate on stone recurrence as well as stone growth post ESWL or PCNL, in patients with calcium-containing stones.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age > 18 years
- stone free or had residual calcium oxalate stone fragments with a less than 4 mm. diameter at eight weeks after ESWL or PCNL
Key exclusion criteria (6 listed)
- renal tubular obstruction
- serum creatinine > 2 mg/dl
- urinary tract infection (bacteria > 100,000 in urine culture)
- hypersensitive or contraindication to Potassium sodium hydrogen citrate
- insertion Double-J Stent
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-sodium citrateAlso: Uralyt-UThe treated group was given oral potassium-sodium citrate 81 mEq/day The control group received no treatment | Drug | – |
Primary outcome
rate of stone recurrence or stone growth
Time frame: 12 months
The patients were evaluated at 6 months after the initial treatment for serum chemistry and urinalysis. After 12 months, all patients were evaluated for serum chemistry, urinalysis, 24-hour urine study and plain KUB.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2011.
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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.
Bannakij Lojanapiwat, MD principal investigator
Division of Urology, Department of Surgery, Chiangmai University, Thailand
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Potassium-sodium citrate in people with Kidney Calculi, run by Ouiheng International Healthcare Co., Ltd.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 5 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of stone recurrence or stone growth (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2011.