Kidney CalculiPhase 4NCT05414669
Allopurinol Effect on MDA,NO,KIM-1 Urine Levels, RI and Renal Elastography in Kidney Stone Patients Post ESWL
A Phase 4 study testing Allopurinol Tablet 300 mg in people with Kidney Calculi, run by RSUP Prof. Dr. I.G.N.G. Ngoerahal at 1 site in Indonesia.
Trial summary
Extracorporeal shock wave lithotripsy (ESWL) is accepted as the first treatment choice for most urinary stones. Still, it has adverse effects on the kidneys. The mechanism underlying the shock wave induced renal injury is not entirely understood, and oxidative stress has been speculated to be involved in this process. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Calculi
- What is being tested?
- Allopurinol Tablet 300 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteIndonesia
- Study dates
- 6 Aug 2020to 20 Apr 2021
- 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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient with renal stone who meet ESWL criteria
- Age 18 to 59 years old
- Consent to join this study
Who cannot join
- Patient with Diabetes Melitus
- Patient with hypertension
- Patient with Chronic Kidney Disease stage IV and stage V
- Patient with urinary tract infection
- Patient with obesity
- Patient with uric acid more than 9mg/dL
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Allopurinol on Malondialdehyde, Nitric Oxide, Kidney Injury Molecule-1 Urine Levels, Resistive Index and Renal Elastography in Kidney Stone Patients After Extra Corporeal Shockwave Lithotripsy
Extracorporeal shock wave lithotripsy (ESWL) is accepted as the first treatment choice for most urinary stones. Still, it has adverse effects on the kidneys. The mechanism underlying the shock wave induced renal injury is not entirely understood, and oxidative stress has been speculated to be involved in this process. The Investigator evaluated the role of allopurinol, which works as a xanthine oxidase inhibitor and free radical scavenger in renal protection against oxidative effects of ESWL. In a randomized, double-blind placebo-controlled trial, a total of 70 patients with renal stones undergoing ESWL were randomly assigned to 2 groups. Group 1 receive allopurinol, and group 2 receive a placebo. Allopurinol 300mg was given orally for a total of 3 days, beginning a day before ESWL. The urinary excretion of malondialdehyde (MDA), nitric oxide (NO), and kidney injury molecule-1 (KIM-1) were determined by quantitative double antibody sandwich direct ELISA at baseline before ESWL then repeatedly two h, and 24 h after ESWL. The resistive index (RI) change of the interlobar artery was asses along with the measurement of the shear wave velocity (SWV) in the focal zone of the treated kidney before, two weeks, and four weeks after ESWL. Multivariate analyses were performed using repeated measure ANOVA to control covariates.
Read the detailed description
Subjects with kidney stones who met the criteria were given a detailed explanation about this study by the research team, then followed by signing the informed consent. History was taken along with physical examination, complete blood count, Bun, creatinine, uric acid, urinalysis and also anthropometric measurements (weight and height). Then each subjects got one of the intervention drugs, either allopurinol 300mg or placebo. Allopurinol 300 mg was finely grounded and put into gelatin capsules. The placebo was made by using Saccharum lactis material which was inserted into a gelatin capsule as well. The shape, color, texture, and weight of the placebo capsules were made the same as the drug allopurinol. Allopurinol capsules and placebo were made by the Pharmacy section of Sanglah Hospital.
Subjects were randomly allocated using a permuted block method into the allopurinol or placebo group. Each subject received one type of capsule consisting of 3 capsules containing 300 mg allopurinol or placebo taken the day before ESWL, 2 hours before ESWL, and the day after ESWL.
The study was conducted double-blind where the researcher, subject, data collector, outcome adjudicator, and data analyst did not know the type of treatment. Medicines are given in sealed envelopes using an undisclosed code that will be uncovered at the end of the study.
For the preparation of ESWL subjects; each subjects got infusion of 0.9% NaCl with 20 drops per minute, ondansetron 8 mg i.v., pethidine bolus 50 mg i.v., followed by drip pethidine 50 mg and ketorolac 30 mg given in 500 ml NaCl 0.9% with 20 drops of 20 drops per minute.
The Investigator performed ESWL using a Siemen litostar vario which uses an electromagnetic generator. The number of shock waves given is 2500-3000 shock waves per session. The given shock wave strength is slim to 2 J in the initial 200 shock wave followed by 3 to 3.5 J in the remainder of the shock wave. The given shock wave frequency is 60 x/minute.
Urine samples were taken aseptically using the mid-portion method in the amount of 10 ml for examination of biomarkers KIM-1, NO, and MDA one hour before ESWL. Furthermore, the urine sample was taken 10 ml two hours after ESWL and one day after ESWL. Examination time after ESWL is calculated from the end of the ESWL session.
RI examination and renal SWV elastography were performed one hour before ESWL, followed by two weeks and one month after ESWL by the same radiology specialist.
Subject compliance with medication is evaluated based on the number of capsules taken from the entire drug administered. If the number of capsules taken is less, the subject will be excluded from the analysis. Adverse events or drug side effects are defined as unexpected events during the study, such as experiencing procedure-related complications or being allergic to allopurinol. The Investigator evaluated the subjects every week after ESWL to assess tolerance and possible side effects.
If there was any drug side effects or serious adverse events(SAE), the subjects were reported to the ethics committee as soon as possible, less than 24 hours from the first time they were discovered, and actions were carried out as quickly as possible until the series of events ends. SAE was written in detail on the SAE form, including the following; when it was first discovered, the manifestation of the incident, the conditions before the incident, the handling of the event, and the outcome.
If the subject experiences side effects such as allergic reactions (redness of the skin, swelling of the eyes or mouth) and severe gastrointestinal disturbances (vomiting, diarrhea), the subject will be excluded from the analysis. The subject will also be excluded from the analysis if they experience complications related to ESWL procedure such as ureteral obstruction, pain (VAS > 5), or there were signs of infection. Subjects will be evaluated when visiting the hospital according to schedule, telephone contact, or by making a home visit.
The envelope of intervention data will be opened after data analysis, witnessed by an independent team, namely the Sanglah Hospital pharmacy and the Sanglah Hospital research division.
- Conditions
- Kidney Calculi
- Being tested
- Allopurinol Tablet 300 mg, Control Group
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allopurinol Tablet 300 mgDrug
Also called Allopurinol
Allopurinol 300mg was given orally for a total of 3 days, beginning a day before ESWL.
Control GroupDrug
Also called Placebo
Placebo was given orally for a total of 3 days, beginning a day before ESWL.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | Allopurinol 300 mg was administered orally for a total of 3 days, starting from the day before ESWL Receives: Drug: Allopurinol Tablet 300 mg |
| Control Group | Placebo comparator | Placebo was administered orally for a total of 3 days, starting from the day before ESWL Receives: Drug: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidative Stress
Level of Malondialdehyde (MDA), Nitric Oxide (NO), and Kidney Injury molecule-1 (KIM-1) in urine were determined by quantitative double antibody sandwich direct ELISA
Measured: Two hours post-ESWL
Oxidative Stress
Level of Malondialdehyde (MDA), Nitric Oxide (NO), and Kidney Injury molecule-1 (KIM-1) in urine were determined by quantitative double antibody sandwich direct ELISA
Measured: 24 hours post ESWL
Renal vascular and biophysical damage
Resistive Index (RI) change of the interlobar artery and elastography of the ipsilateral renal focal zone at ESWL
Measured: Two weeks after ESWL
Renal vascular and biophysical damage
Resistive Index (RI) change of the interlobar artery and elastography of the ipsilateral renal focal zone at ESWL
Measured: One month after ESWL
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start6 Aug 2020
- Primary completion1 Mar 2021
- Study completion20 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (76)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- RSUP Prof. Dr. I.G.N.G. Ngoerahal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kadek Budi Santosa, RSUP Prof. Dr. I.G.N.G. Ngoerahal
- Investigators
- Kadek B Santosa, Urologist, Principal investigator, RSUP Prof. Dr. I.G.N.G. Ngoerahal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05414669
- Sponsor's protocol ID
- 2020.03.1.0645
- Status last verified
- Jun 2022
- First submitted
- 27 Apr 2022
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are no going to share any individual participant data (IPD) considering Participant's Confidentiality.
Publications
Acharya, C.R., Sharma, A.K., and Kantharia, N.D. 2015. Involvement of oxidative stress in patients of gout and antioxidant effect of allopurinol. International Journal of Medical Science and Public Health; 4(2): pp 168 -172
Aksoy H, Aksoy Y, Turhan H, Keles S, Ziypak T, Ozbey I. The effect of shock wave lithotripsy on nitric oxide and malondialdehyde levels in plasma and urine samples. Cell Biochem Funct. 2007 Sep-Oct;25(5):533-6. doi: 10.1002/cbf.1349.
PubMed 16850521Denic A, Mathew J, Lerman LO, Lieske JC, Larson JJ, Alexander MP, Poggio E, Glassock RJ, Rule AD. Single-Nephron Glomerular Filtration Rate in Healthy Adults. N Engl J Med. 2017 Jun 15;376(24):2349-2357. doi: 10.1056/NEJMoa1614329.
PubMed 28614683Alirezaei, A., Argani, H., Asgharpour, M., Bahadorimonfared, A., and Bakhtiyari, M. 2017. An update on allopurinol and kidney failure; new trend for an old drug. J Renal Inj Prev; 6(4): pp 297-302
Alessio HM. 2000. In: Handbook of oxidants and antioxidants in exercise. Hanninen O, Packy L, Sen CK, editors. Elsevier; Amsterdam; pp 115-128
Asnita Arif, Nurlaily Idris, Bachtiar Murtala, Andi Alfian Z, Sri Asriyani, and Hasyim Kasim. 2019. The Correlation Between Renal Shear Wave Elastography with Estimated Glomerular FiltrationRate in Chronic Kidney Disease. Jurnal Kedokteran Brawijaya; 30(4): pp 287-292
Berry CE, Hare JM. Xanthine oxidoreductase and cardiovascular disease: molecular mechanisms and pathophysiological implications. J Physiol. 2004 Mar 16;555(Pt 3):589-606. doi: 10.1113/jphysiol.2003.055913. Epub 2003 Dec 23.
PubMed 14694147Bonventre JV. Kidney injury molecule-1 (KIM-1): a urinary biomarker and much more. Nephrol Dial Transplant. 2009 Nov;24(11):3265-8. doi: 10.1093/ndt/gfp010. Epub 2009 Mar 23. No abstract available.
PubMed 19318357Bonventre JV. Primary proximal tubule injury leads to epithelial cell cycle arrest, fibrosis, vascular rarefaction, and glomerulosclerosis. Kidney Int Suppl (2011). 2014 Nov;4(1):39-44. doi: 10.1038/kisup.2014.8.
PubMed 26310195Brian R, Matlaga, Amy E. Krambeck, and James E. Lingeman. 2016. Surgical management of Upper Urinary Tract Calculi. Campbell-Walsh urology. Philadelphia: Elsevier; pp 1260-1276
Burne-Taney MJ, Ascon DB, Daniels F, Racusen L, Baldwin W, Rabb H. B cell deficiency confers protection from renal ischemia reperfusion injury. J Immunol. 2003 Sep 15;171(6):3210-5. doi: 10.4049/jimmunol.171.6.3210.
PubMed 12960350Busti A.J. 2015. The Differences in the Mechanisms of Action Between Allopurineol and Febuxostat. Available at: http://www.ebmconsult.com/articles/allopurinol\ and febuxostat-zyloprim-uloric-uric-acid-gout-mechanism. Accesed 9th August 2016
Chawla LS, Eggers PW, Star RA, Kimmel PL. Acute kidney injury and chronic kidney disease as interconnected syndromes. N Engl J Med. 2014 Jul 3;371(1):58-66. doi: 10.1056/NEJMra1214243. No abstract available.
PubMed 24988558Coca SG, Yusuf B, Shlipak MG, Garg AX, Parikh CR. Long-term risk of mortality and other adverse outcomes after acute kidney injury: a systematic review and meta-analysis. Am J Kidney Dis. 2009 Jun;53(6):961-73. doi: 10.1053/j.ajkd.2008.11.034. Epub 2009 Apr 5.
PubMed 19346042Dahlan, M. Sopiyudin. 2009. Besar Sampel dan Pengambilan Sampel, dalam Penelitian Kedokteran dan Kesehatan. Jakarta: Salemba Medika
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Allopurinol on Malondialdehyde, Nitric Oxide, Kidney Injury Molecule-1 Urine Levels, Resistive Index and Renal Elastography in Kidney Stone Patients After Extra Corporeal Shockwave Lithotripsy
- ClinicalTrials.gov ID
- NCT05414669
- Acronym / sponsor ID
- 2020.03.1.0645
- Conditions
- Kidney Calculi
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- RSUP Prof. Dr. I.G.N.G. NgoerahalUniversity, hospital or other
- Study start
- 6 Aug 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 20 Apr 2021 (actual)
- First posted
- 10 Jun 2022 (actual)
- 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) is accepted as the first treatment choice for most urinary stones. Still, it has adverse effects on the kidneys. The mechanism underlying the shock wave induced renal injury is not entirely understood, and oxidative stress has been speculated to be involved in this process. The Investigator evaluated the role of allopurinol, which works as a xanthine oxidase inhibitor and free radical scavenger in renal protection against oxidative effects of ESWL. In a randomized, double-blind placebo-controlled trial, a total of 70 patients with renal stones undergoing ESWL were randomly assigned to 2 groups. Group 1 receive allopurinol, and group 2 receive a placebo. Allopurinol 300mg was given orally for a total of 3 days, beginning a day before ESWL. The urinary excretion of malondialdehyde (MDA), nitric oxide (NO), and kidney injury molecule-1 (KIM-1) were determined by quantitative double antibody sandwich direct ELISA at baseline before ESWL then repeatedly two h, and 24 h after ESWL. The resistive index (RI) change of the interlobar artery was asses along with the measurement of the shear wave velocity (SWV) in the focal zone of the treated kidney before, two weeks, and four weeks after ESWL. Multivariate analyses were performed using repeated measure ANOVA to control covariates.
Detailed description
Subjects with kidney stones who met the criteria were given a detailed explanation about this study by the research team, then followed by signing the informed consent. History was taken along with physical examination, complete blood count, Bun, creatinine, uric acid, urinalysis and also anthropometric measurements (weight and height). Then each subjects got one of the intervention drugs, either allopurinol 300mg or placebo. Allopurinol 300 mg was finely grounded and put into gelatin capsules. The placebo was made by using Saccharum lactis material which was inserted into a gelatin capsule as well. The shape, color, texture, and weight of the placebo capsules were made the same as the drug allopurinol. Allopurinol capsules and placebo were made by the Pharmacy section of Sanglah Hospital.
Subjects were randomly allocated using a permuted block method into the allopurinol or placebo group. Each subject received one type of capsule consisting of 3 capsules containing 300 mg allopurinol or placebo taken the day before ESWL, 2 hours before ESWL, and the day after ESWL.
The study was conducted double-blind where the researcher, subject, data collector, outcome adjudicator, and data analyst did not know the type of treatment. Medicines are given in sealed envelopes using an undisclosed code that will be uncovered at the end of the study.
For the preparation of ESWL subjects; each subjects got infusion of 0.9% NaCl with 20 drops per minute, ondansetron 8 mg i.v., pethidine bolus 50 mg i.v., followed by drip pethidine 50 mg and ketorolac 30 mg given in 500 ml NaCl 0.9% with 20 drops of 20 drops per minute.
The Investigator performed ESWL using a Siemen litostar vario which uses an electromagnetic generator. The number of shock waves given is 2500-3000 shock waves per session. The given shock wave strength is slim to 2 J in the initial 200 shock wave followed by 3 to 3.5 J in the remainder of the shock wave. The given shock wave frequency is 60 x/minute.
Urine samples were taken aseptically using the mid-portion method in the amount of 10 ml for examination of biomarkers KIM-1, NO, and MDA one hour before ESWL. Furthermore, the urine sample was taken 10 ml two hours after ESWL and one day after ESWL. Examination time after ESWL is calculated from the end of the ESWL session.
RI examination and renal SWV elastography were performed one hour before ESWL, followed by two weeks and one month after ESWL by the same radiology specialist.
Subject compliance with medication is evaluated based on the number of capsules taken from the entire drug administered. If the number of capsules taken is less, the subject will be excluded from the analysis. Adverse events or drug side effects are defined as unexpected events during the study, such as experiencing procedure-related complications or being allergic to allopurinol. The Investigator evaluated the subjects every week after ESWL to assess tolerance and possible side effects.
If there was any drug side effects or serious adverse events(SAE), the subjects were reported to the ethics committee as soon as possible, less than 24 hours from the first time they were discovered, and actions were carried out as quickly as possible until the series of events ends. SAE was written in detail on the SAE form, including the following; when it was first discovered, the manifestation of the incident, the conditions before the incident, the handling of the event, and the outcome.
If the subject experiences side effects such as allergic reactions (redness of the skin, swelling of the eyes or mouth) and severe gastrointestinal disturbances (vomiting, diarrhea), the subject will be excluded from the analysis. The subject will also be excluded from the analysis if they experience complications related to ESWL procedure such as ureteral obstruction, pain (VAS > 5), or there were signs of infection. Subjects will be evaluated when visiting the hospital according to schedule, telephone contact, or by making a home visit.
The envelope of intervention data will be opened after data analysis, witnessed by an independent team, namely the Sanglah Hospital pharmacy and the Sanglah Hospital research division.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Drug: Allopurinol Tablet 300 mgAllopurinol 300 mg was administered orally for a total of 3 days, starting from the day before ESWL |
| Control Group | Placebo comparator | Drug: Control GroupPlacebo was administered orally for a total of 3 days, starting from the day before ESWL |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patient with renal stone who meet ESWL criteria
- Age 18 to 59 years old
- Consent to join this study
Key exclusion criteria (6 listed)
- Patient with Diabetes Melitus
- Patient with hypertension
- Patient with Chronic Kidney Disease stage IV and stage V
- Patient with urinary tract infection
- Patient with obesity
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 |
|---|---|---|
| Allopurinol Tablet 300 mgAlso: AllopurinolAllopurinol 300mg was given orally for a total of 3 days, beginning a day before ESWL. | Drug | Interventional group |
| Control GroupAlso: PlaceboPlacebo was given orally for a total of 3 days, beginning a day before ESWL. | Drug | Control Group |
Primary outcome
Oxidative Stress
Time frame: Two hours post-ESWL
Level of Malondialdehyde (MDA), Nitric Oxide (NO), and Kidney Injury molecule-1 (KIM-1) in urine were determined by quantitative double antibody sandwich direct ELISA
Oxidative Stress
Time frame: 24 hours post ESWL
Level of Malondialdehyde (MDA), Nitric Oxide (NO), and Kidney Injury molecule-1 (KIM-1) in urine were determined by quantitative double antibody sandwich direct ELISA
Renal vascular and biophysical damage
Time frame: Two weeks after ESWL
Resistive Index (RI) change of the interlobar artery and elastography of the ipsilateral renal focal zone at ESWL
Renal vascular and biophysical damage
Time frame: One month after ESWL
Resistive Index (RI) change of the interlobar artery and elastography of the ipsilateral renal focal zone at ESWL
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 10 Jun 2022.
- BackgroundAcharya, C.R., Sharma, A.K., and Kantharia, N.D. 2015. Involvement of oxidative stress in patients of gout and antioxidant effect of allopurinol. International Journal of Medical Science and Public Health; 4(2): pp 168 -172
- Background: PubMed 16850521Aksoy H, Aksoy Y, Turhan H, Keles S, Ziypak T, Ozbey I. The effect of shock wave lithotripsy on nitric oxide and malondialdehyde levels in plasma and urine samples. Cell Biochem Funct. 2007 Sep-Oct;25(5):533-6. doi: 10.1002/cbf.1349.
- Background: PubMed 28614683Denic A, Mathew J, Lerman LO, Lieske JC, Larson JJ, Alexander MP, Poggio E, Glassock RJ, Rule AD. Single-Nephron Glomerular Filtration Rate in Healthy Adults. N Engl J Med. 2017 Jun 15;376(24):2349-2357. doi: 10.1056/NEJMoa1614329.
- BackgroundAlirezaei, A., Argani, H., Asgharpour, M., Bahadorimonfared, A., and Bakhtiyari, M. 2017. An update on allopurinol and kidney failure; new trend for an old drug. J Renal Inj Prev; 6(4): pp 297-302
- BackgroundAlessio HM. 2000. In: Handbook of oxidants and antioxidants in exercise. Hanninen O, Packy L, Sen CK, editors. Elsevier; Amsterdam; pp 115-128
- BackgroundAsnita Arif, Nurlaily Idris, Bachtiar Murtala, Andi Alfian Z, Sri Asriyani, and Hasyim Kasim. 2019. The Correlation Between Renal Shear Wave Elastography with Estimated Glomerular FiltrationRate in Chronic Kidney Disease. Jurnal Kedokteran Brawijaya; 30(4): pp 287-292
- Background: PubMed 14694147Berry CE, Hare JM. Xanthine oxidoreductase and cardiovascular disease: molecular mechanisms and pathophysiological implications. J Physiol. 2004 Mar 16;555(Pt 3):589-606. doi: 10.1113/jphysiol.2003.055913. Epub 2003 Dec 23.
- Background: PubMed 19318357Bonventre JV. Kidney injury molecule-1 (KIM-1): a urinary biomarker and much more. Nephrol Dial Transplant. 2009 Nov;24(11):3265-8. doi: 10.1093/ndt/gfp010. Epub 2009 Mar 23. No abstract available.
- Background: PubMed 26310195Bonventre JV. Primary proximal tubule injury leads to epithelial cell cycle arrest, fibrosis, vascular rarefaction, and glomerulosclerosis. Kidney Int Suppl (2011). 2014 Nov;4(1):39-44. doi: 10.1038/kisup.2014.8.
- BackgroundBrian R, Matlaga, Amy E. Krambeck, and James E. Lingeman. 2016. Surgical management of Upper Urinary Tract Calculi. Campbell-Walsh urology. Philadelphia: Elsevier; pp 1260-1276
- Background: PubMed 12960350Burne-Taney MJ, Ascon DB, Daniels F, Racusen L, Baldwin W, Rabb H. B cell deficiency confers protection from renal ischemia reperfusion injury. J Immunol. 2003 Sep 15;171(6):3210-5. doi: 10.4049/jimmunol.171.6.3210.
- BackgroundBusti A.J. 2015. The Differences in the Mechanisms of Action Between Allopurineol and Febuxostat. Available at: http://www.ebmconsult.com/articles/allopurinol\ and febuxostat-zyloprim-uloric-uric-acid-gout-mechanism. Accesed 9th August 2016
- Individual participant dataSharing planned: No. We are no going to share any individual participant data (IPD) considering Participant's Confidentiality.
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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.
Kadek B Santosa, Urologist principal investigator
RSUP Prof. Dr. I.G.N.G. Ngoerahal
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 Allopurinol Tablet 300 mg in people with Kidney Calculi, run by RSUP Prof. Dr. I.G.N.G. Ngoerahal at 1 site in Indonesia.
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 3 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 10 Jun 2022. 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 Indonesia. 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. Some participants in this study may receive a placebo. 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?
Oxidative Stress (time frame: Two hours post-ESWL). The study lists 4 primary outcomes in all. 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 NCT05414669, which also lists 76 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 10 Jun 2022.