UrolithiasisPhase 4NCT02373384
The Predictors of Successful Oral Dissolution Therapy in Radiolucent Renal Stones; A Prospective Evaluation
A Phase 4 study testing Oral alkalinization (Potassium citrate, Allopurinol), Life style modification and Dietary recommendations (decrease purine rich diet as red meat and fish, increase vegetables) in people with Urolithiasis and Renal Stones, run by Mansoura University at 1 site in Egypt.
Trial summary
The aim of the study is to evaluate the predictors of success of oral dissolution therapy in radiolucent renal stones in a large series of patients from a tertiary referral center in order to define the optimum case scenarios where oral dissolution therapy could be implemented. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urolithiasis, Renal Stones
- What is being tested?
- Oral alkalinization (Potassium citrate, Allopurinol), Life style modification and Dietary recommendations (decrease purine rich diet as red meat and fish, increase vegetables)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2015to Jun 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients' criteria:
- Ability to give informed consent.
- Age more than 18 years.
- Absence of significant hydronephrosis, serious urinary tract infection, congenital anomalies or distal ureteric obstruction in the affected renal unit.
- Normal cardiac, hematological, and renal functions.
- Stone criteria:
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- Primary or recurrent renal stone.
- Patients with residual renal stones after primary intervention whether open surgery, endoscopic or ESWL.
- Peripheral calyceal stones or stone in the renal pelvis with no significant hydronephrosis.
- Stone size less than 3 cm in maximum diameter
- Stones with radiodensity less than 600 Hounsefield units attenuation in Non Contrast Computed Tomography (NCCT).
Who cannot join
- Patients' criteria:
- Inability to give informed consent.
- Age less than 18 years
- Patients with unremitting pain or serious urinary tract infection.
- Presence of significant hydronephrosis, congenital anomalies or distal ureteric obstruction in the affected renal unit.
- Abnormal cardiac, hematological or renal functions.
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- Stone criteria:
- Obstructing stone in the renal pelvis with significant hydronephrosis.
- Assumption of presence of calcium stones by presence of calcification in the stone in plain X-rays.
- -
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to evaluate the predictors of success of oral dissolution therapy in radiolucent renal stones in a large series of patients from a tertiary referral center in order to define the optimum case scenarios where oral dissolution therapy could be implemented.
Read the detailed description
Patients with renal stones, seen through the outpatient clinic in the urology department or post primary intervention for renal stones, will be assessed to see if the patient satisfies all inclusion and exclusion criteria. Patients who are meeting these criteria will be asked to participate in this prospective study. If they agree, they will be asked to sign an informed consent.
Baseline patients' assessment will include;
- Full history taking including
- Previous stone history regarding presentation and management
- Previous trial oral dissolution therapy for renal stones and their compliance to the treatment
- Previous GIT surgery
- History of chronic medical or metabolic illness e.g; DM
- Clinical examination including
- Body mass index (BMI)
- Laboratory investigations including;
- Urine analysis (urine PH)
- 24 hours urine testing for uric acid and citrate
- Urine culture
- Serum creatinine
- Random blood sugar (RBS)
- Serum uric acid
- Serum calcium, phosphorus and magnesium.
- Initial radiological evaluation will include
- Renal ultrasonography (US)
- Plain X-rays to exclude the presence of calcification in the targeted stone.
- Non Contrast Computed Tomography (NCCT) on the abdomen and pelvis.
- MAG3 diuretic renogram (All NCCT studies will be performed with multislice helical CT scanners, NCCT images will be obtained from above the kidneys through the bladder base. For each renal stone, its location will be recorded, its size will be measured using the largest dimension from length (L), width (W) and height (H) on axial and coronal reformat images. Its mean density will be recorded by measurement using region of interest just smaller than the stone. Associated hydronephrosis proximal to the stone will be also evaluated (Nakada et al 2000).)
Patient will receive the allocated instructions and medications
Patients' follow up (The aim at follow up is to monitor the urinary PH with adjustment of the dose of potassium citrate and also to assess the compliance of the patients regarding the dietary recommendations and the medications)
- After 2 weeks, 4 weeks, 8 weeks and 12 weeks.
- the most important parameter will be assessed is the urinary PH every two weeks. The target urinary PH should be kept between6.5 to 7.0, the dose of potassium citrate should be adjusted to achieve this value.
- Patients' compliance to medications intake and the instruction of fluid intake and dietary modification.
- Conditions
- Urolithiasis, Renal Stones
- Being tested
- Oral alkalinization (Potassium citrate, Allopurinol), Life style modification, Dietary recommendations (decrease purine rich diet as red meat and fish, increase vegetables)
- Keywords
- Radiolucent renal stones, Oral dissolution therapy, Systemic chemolysis, Renal uric acid stones, Alkalinization
- Medical subject headings
- Urolithiasis, Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral alkalinization (Potassium citrate, Allopurinol)Drug
Also called systemic chemolysis
Eligible patients, who fulfilled the study criteria, will be instructed For; Oral alkalinization therapy
- Potassium citrate 20 mEq three times daily
- Hyperuricosuric patients (24-hours urine uric acid more than 750 mg/day in male and more than 650mg/day in females) will receive:
Allopurinol, a competitive inhibitor of xanthine oxidase, in a dose of 300 mg daily.
Life style modificationBehavioural
Eligible patients, who fulfilled the study criteria, will be also instructed for;
Adequate fluid intake in order to maintain urine volume between 2-3 L per day.
Dietary recommendations (decrease purine rich diet as red meat and fish, increase vegetables)Dietary supplement
Eligible patients, who fulfilled the study criteria and they are hyperuricosuric (24-hours urine uric acid more than 750 mg/day in male and more than 650mg/day in females) will be also instructed for; Dietary modification will be advised in the form of decrease purine rich diet as red meat and fish, increase vegetables.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Eligible patients, who fulfilled the study criteria, will be instructed For;
1. Oral alkalinization
* Potassium citrate 20 mEq three times daily
* Hyperuricosuric patients (24-hours urine uric acid more than 750 mg/day in male and more than 650mg/day in females), will receive Allopurinol, a competitive inhibitor of xanthine oxidase, in a dose of 300 mg daily.
2. Life style modification Adequate fluid intake in order to maintain urine volume between 2-3 L per day.
3. Dietary recommendations
In hyperuricosuric patients (24-hours urine uric acid more than 750 mg/day in male and more than 650mg/day in females) ;
- Dietary modification will be advised in the form of decrease purine rich diet as red meat and fish, increase vegetables. Receives: Drug: Oral alkalinization (Potassium citrate, Allopurinol); Behavioral: Life style modification; Dietary Supplement: Dietary recommendations (decrease purine rich diet as red meat and fish, increase vegetables) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of this study will be change in stone surface area after 3 months of the determined protocol
The stone surface area will be measured using the formula; Surface area = length X width X 0.25 X (22/7) Comparison of the stone surface area in relation to the initial surface area will be done.
Measured: participants will be followed for the duration of medical treatment which is specified to be 3 months
Secondary outcomes (1)
Assessment of the predictors of response (more than 50% reduction in the surface area of the stone) to medical treatment
The percent reduction of stone surface area will be calculated using the formula:
Surface area = length X width X 0.25 X (22/7)
Categorization of the patients into three groups will be done:
- Patients who achieved 50% or more reduction in the stone surface area will be considered responsive and would be counseled for another 3 months therapy.
- Patients with partial response, less than 50% reduction in stone surface area will be counseled for auxiliary procedure based on stone criteria e.g. ESWL.
- Patients with no response/ serious renal infections or serious treatment adverse effects will be considered for other interventional treatment modalities.
In the responders groups, factors predicting the success of treatment will be determined
Measured: participants will be followed for the duration of medical treatment which is specified to be 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Abdel-Lateif El-Sawy, Mansoura University
- Investigators
- Ahmed A. Shokeir, MD, Study chair, Urology And Nephrology Center, Mansoura University, Mansoura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02373384
- Sponsor's protocol ID
- AEl-Sawy122015
- Status last verified
- Mar 2018
- First submitted
- 13 Feb 2015
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictors of Successful Oral Dissolution Therapy in Radiolucent Renal Stones; A Prospective Evaluation
- ClinicalTrials.gov ID
- NCT02373384
- Acronym / sponsor ID
- AEl-Sawy122015
- Conditions
- Urolithiasis, Renal Stones
- Keywords
- Radiolucent renal stones, Oral dissolution therapy, Systemic chemolysis, Renal uric acid stones, Alkalinization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Feb 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 27 Feb 2015 (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.
The aim of the study is to evaluate the predictors of success of oral dissolution therapy in radiolucent renal stones in a large series of patients from a tertiary referral center in order to define the optimum case scenarios where oral dissolution therapy could be implemented.
Detailed description
Patients with renal stones, seen through the outpatient clinic in the urology department or post primary intervention for renal stones, will be assessed to see if the patient satisfies all inclusion and exclusion criteria. Patients who are meeting these criteria will be asked to participate in this prospective study. If they agree, they will be asked to sign an informed consent.
Baseline patients' assessment will include;
- Full history taking including
- Previous stone history regarding presentation and management
- Previous trial oral dissolution therapy for renal stones and their compliance to the treatment
- Previous GIT surgery
- History of chronic medical or metabolic illness e.g; DM
- Clinical examination including
- Body mass index (BMI)
- Laboratory investigations including;
- Urine analysis (urine PH)
- 24 hours urine testing for uric acid and citrate
- Urine culture
- Serum creatinine
- Random blood sugar (RBS)
- Serum uric acid
- Serum calcium, phosphorus and magnesium.
- Initial radiological evaluation will include
- Renal ultrasonography (US)
- Plain X-rays to exclude the presence of calcification in the targeted stone.
- Non Contrast Computed Tomography (NCCT) on the abdomen and pelvis.
- MAG3 diuretic renogram (All NCCT studies will be performed with multislice helical CT scanners, NCCT images will be obtained from above the kidneys through the bladder base. For each renal stone, its location will be recorded, its size will be measured using the largest dimension from length (L), width (W) and height (H) on axial and coronal reformat images. Its mean density will be recorded by measurement using region of interest just smaller than the stone. Associated hydronephrosis proximal to the stone will be also evaluated (Nakada et al 2000).)
Patient will receive the allocated instructions and medications
Patients' follow up (The aim at follow up is to monitor the urinary PH with adjustment of the dose of potassium citrate and also to assess the compliance of the patients regarding the dietary recommendations and the medications)
- After 2 weeks, 4 weeks, 8 weeks and 12 weeks.
- the most important parameter will be assessed is the urinary PH every two weeks. The target urinary PH should be kept between6.5 to 7.0, the dose of potassium citrate should be adjusted to achieve this value.
- Patients' compliance to medications intake and the instruction of fluid intake and dietary modification.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: Oral alkalinization (Potassium citrate, Allopurinol), Behavioral: Life style modification, Dietary Supplement: Dietary recommendations (decrease purine rich diet as red meat and fish, increase vegetables)Eligible patients, who fulfilled the study criteria, will be instructed For; 1. Oral alkalinization * Potassium citrate 20 mEq three times daily * Hyperuricosuric patients (24-hours urine uric acid more than 750 mg/day in male and more than 650mg/day in females), will receive Allopurinol, a competitive inhibitor of xanthine oxidase, in a dose of 300 mg daily. 2. Life style modification Adequate fluid intake in order to maintain urine volume between 2-3 L per day. 3. Dietary recommendations In hyperuricosuric patients (24-hours urine uric acid more than 750 mg/day in male and more than 650mg/day in females) ; - Dietary modification will be advised in the form of decrease purine rich diet as red meat and fish, increase vegetables. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients' criteria:
- Stone criteria:
Key exclusion criteria (10 listed)
- Patients' criteria:
- Stone criteria:
- -
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 |
|---|---|---|
| Oral alkalinization (Potassium citrate, Allopurinol)Also: systemic chemolysisEligible patients, who fulfilled the study criteria, will be instructed For; Oral alkalinization therapy * Potassium citrate 20 mEq three times daily * Hyperuricosuric patients (24-hours urine uric acid more than 750 mg/day in male and more than 650mg/day in females) will receive: Allopurinol, a competitive inhibitor of xanthine oxidase, in a dose of 300 mg daily. | Drug | Study group |
| Life style modificationEligible patients, who fulfilled the study criteria, will be also instructed for; Adequate fluid intake in order to maintain urine volume between 2-3 L per day. | Behavioural | Study group |
| Dietary recommendations (decrease purine rich diet as red meat and fish, increase vegetables)Eligible patients, who fulfilled the study criteria and they are hyperuricosuric (24-hours urine uric acid more than 750 mg/day in male and more than 650mg/day in females) will be also instructed for; Dietary modification will be advised in the form of decrease purine rich diet as red meat and fish, increase vegetables. | Dietary supplement | Study group |
Primary outcome
The primary endpoint of this study will be change in stone surface area after 3 months of the determined protocol
Time frame: participants will be followed for the duration of medical treatment which is specified to be 3 months
The stone surface area will be measured using the formula; Surface area = length X width X 0.25 X (22/7) Comparison of the stone surface area in relation to the initial surface area will be done.
1 secondary outcome
Assessment of the predictors of response (more than 50% reduction in the surface area of the stone) to medical treatment
Time frame: participants will be followed for the duration of medical treatment which is specified to be 3 months
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 22 Mar 2018.
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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.
Ahmed A. Shokeir, MD study chair
Urology And Nephrology Center, Mansoura University, Mansoura
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral alkalinization (Potassium citrate, Allopurinol), Life style modification and Dietary recommendations (decrease purine rich diet as red meat and fish, increase vegetables) in people with Urolithiasis and Renal Stones, run by Mansoura University at 1 site in Egypt.
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 11 inclusion and 10 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 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
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?
The primary endpoint of this study will be change in stone surface area after 3 months of the determined protocol (time frame: participants will be followed for the duration of medical treatment which is specified to be 3 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 22 Mar 2018.