Ulcerative ColitisEarly Phase 1NCT06525974
Clinical Study to Evaluate the Possible Efficacy and Safety of Febuxostat in Patients With Ulcerative Colitis Treated With Mesalamine
A Early Phase 1 study testing Febuxostat and Mesalamine in people with Ulcerative Colitis, run by Tanta University.
Trial summary
Evaluation the possible efficacy and safety of febuxostat in patients with ulcerative colitis treated with mesalamine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Febuxostat and Mesalamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 30 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years old.
- Both male and female will be included.
- Mild and moderate UC patients diagnosed and confirmed by endoscope.
- Patient treated with 5-aminosalislic acid (mesalamine).
Who cannot join
- Patients with severe UC.
- Significant liver and kidney function abnormalities.
- Diabetic patients.
- Patients with Colorectal cancer patients.
- Patients taking rectal or systemic steroids.
- Patients on immunosuppressants or biological therapies.
Show all 16Show fewer
- Addiction to alcohol and / or drugs.
- Known allergy to the studied medications.
- History of complete or partial colectomy.
- Patients with congestive heart failure, other heart disease (Arrhythmia, ischemic heart disease including angina and myocardial infarction).
- Patients with other inflammatory diseases and active infection.
- Patients with stressful condition (COPD, morbid obesity).
- Patients with liver disease.
- Patients with thrombocytopenia and neutropenia.
- Pregnant or lactating females.
- Patients were treated with mercaptopurine.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Evaluation the possible efficacy and safety of febuxostat in patients with ulcerative colitis treated with mesalamine.
Read the detailed description
Ulcerative colitis (UC) is a sub-category of inflammatory bowel diseases (IBD) that causes mucosal inflammation in the rectum and lower colon. Although the exact pathogenesis of ulcerative colitis remains unclear, potential risk factors include altered immune responses, overactive immune response toward commensal microflora, genetic susceptibility, and environmental factors that have been considered as potential risk factors for UC .
The pathogenesis of UC consists of immuno-inflammatory pathways related to the multiple components of the intestine, including the epithelial barrier, dysregulation of immunological responses, leukocyte recruitment, and genetic factors. The understanding of immuno-inflammatory pathways of UC might lead to the development of a specific therapy and/or a novel treatment that could be more efficient .
Mesalazine (also known as mesalamine or 5- amino salicylic acid, 5-ASA) has a well-established role in UC management. It is the first line therapy for mild to moderate UC and it is considered the cornerstone in the management of UC. The mechanism of action of mesalazine is diverse. It acts locally on colonic mucosa and reduces inflammation by several anti-inflammatory processes .
Febuxostat (FXT) is a medication used in management hyperuricemia espicially in gout, a condition characterized by joints pain as result of deposition of uric acid crystals due to elevated urate blood levels. It's a non-purine selective xanthine oxidase inhibitor. Xanthin oxidase is an enzyme that plays a main role in production of uric acid from xanthine and hypoxanthine.
Furthermore, there is no need for dose modification of FXT in case of renal impairment and so it's great choice for many patients as it may exhibit renal protective effect and delay progression of kidney injury and according to Zhou H et al. FXT appears to be well tolerated in healthy population who has normal serum uric acid levels with no serious adverse events were reported .
Lately, febuxostat's spectrum of use has expanded over hyperuricemia management as result of it's ability of amelioration oxidative stress and regulation inflammatory response due to pro -inflammatory cytokines modulation.
Keyvan Amirshahrokhi and El-Mahdy NA et al. inspected the potential of FXT in mitigating ulcerative colitis in mice. The findings from those studies suggest that febuxostat may exert anti- inflammatory effects in the context of ulcerative colitis. Febuxostat's anti- inflammatory effects in ulcerative colitis may be linked to its inhibition of the nuclear factor kappa B (NF-κB) signaling pathway, a key regulator of inflammation. This inhibition can reduce the production of proinflammatory cytokines, contributing to its anti-inflammatory properties .
Although, preclinical studies in animal models are promising, translating these results into clinical applications is necessary to evaluate the safety and efficacy of FXT in managing UC in human.
- Conditions
- Ulcerative Colitis
- Being tested
- Febuxostat, Mesalamine
- Keywords
- Ulcerative Colitis, Febuxostat, Mesalamine
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FebuxostatDrug
40mg of Febuxostat once daily
MesalamineDrug
1 g mesalamine three times daily for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Control group (Mesalamine group) | Active comparator | Control group (Mesalamine group, n =23) who will receive 1 g mesalamine three times daily for 3 months. Receives: Drug: Mesalamine |
| Experimental group (Febuxostat group) | Experimental | Experimental group (Febuxostat group, n = 23) which will receive the standard treatment for UC plus 40 mg febuxostat once daily for 3 months. Receives: Drug: Febuxostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of disease activity using Partial Mayo Scoring Index (PMSI) assessment for Ulcerative Colitis Activity.
It depends on three items: stool frequency, rectal bleeding (blood in stool) and Physician's Global Assessment. Each item has a score from 0 to 3 and total PMSI is the sum of scores for the three items.
Measured: 3 months
Health-related quality of life (HRQOL) using the short inflammatory bowel disease questionnaire .
Short Inflammatory Bowel Disease Ques-tionnaire (SIBDQ) version became widely known and is currently used worldwide both in clinical practice and clinical research. SIBDQ comprises a total of 10 questions grouped into four different dimensions: social, bowel, emotional, and systemic [6, 7]. Each question is scored by a 7-point Likert scale, ranging from 1 (a severe problem) to 7 (not a problem at all), giving an absolute SIBDQ score ranging from 10 (poor HRQoL) to 70 (opti-mal HRQoL). A SIBDQ score below 50 was considered as poor QoL.there are no validated cut-offs for the dif-ferent dimensions' scores. Hence, higher scores indicate a better HRQoL concerning that specific domain.Although patient-reported outcomes are highly valu-able for better patient care, patient responses to HRQoL instruments can be impacted by underlying cultural trends
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start1 Sep 2024 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Mohammed El-kabbary Hasan Diab, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525974
- Sponsor's protocol ID
- MS.24.04.2758
- Status last verified
- Jul 2024
- First submitted
- 29 Jun 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Abdel-Wahab BA, El-Shoura EAM, Shafiuddin Habeeb M, Zafaar D. Febuxostat alleviates Arsenic Trioxide-Induced renal injury in Rats: Insights on the crosstalk between NLRP3/TLR4, Sirt-1/NF-kappaB/TGF-beta signaling Pathways, and miR-23b-3p, miR-181a-5b expression. Biochem Pharmacol. 2023 Oct;216:115794. doi: 10.1016/j.bcp.2023.115794. Epub 2023 Sep 7.
PubMed 37689273Amirshahrokhi K. Febuxostat attenuates ulcerative colitis by the inhibition of NF-kappaB, proinflammatory cytokines, and oxidative stress in mice. Int Immunopharmacol. 2019 Nov;76:105884. doi: 10.1016/j.intimp.2019.105884. Epub 2019 Sep 6.
PubMed 31499267Cicero AFG, Fogacci F, Kuwabara M, Borghi C. Therapeutic Strategies for the Treatment of Chronic Hyperuricemia: An Evidence-Based Update. Medicina (Kaunas). 2021 Jan 10;57(1):58. doi: 10.3390/medicina57010058.
PubMed 33435164El-Mahdy NA, Saleh DA, Amer MS, Abu-Risha SE. Role of allopurinol and febuxostat in the amelioration of dextran-induced colitis in rats. Eur J Pharm Sci. 2020 Jan 1;141:105116. doi: 10.1016/j.ejps.2019.105116. Epub 2019 Oct 23.
PubMed 31654756Elsisi AEE, Sokar SS, Shalaby MF, Abu-Risha SE. Nephroprotective effects of febuxostat and/or mirtazapine against gentamicin-induced nephrotoxicity through modulation of ERK 1/2, NF-kappaB and MCP1. Expert Rev Clin Pharmacol. 2021 Aug;14(8):1039-1050. doi: 10.1080/17512433.2021.1933435. Epub 2021 Jun 9.
PubMed 34030558Fukui T, Maruyama M, Yamauchi K, Yoshitaka S, Yasuda T, Abe Y. Effects of Febuxostat on Oxidative Stress. Clin Ther. 2015 Jul 1;37(7):1396-401. doi: 10.1016/j.clinthera.2015.03.026. Epub 2015 Apr 23.
PubMed 25913922Hao G, Duan W, Sun J, Liu J, Peng B. Effects of febuxostat on serum cytokines IL-1, IL-4, IL-6, IL-8, TNF-alpha and COX-2. Exp Ther Med. 2019 Jan;17(1):812-816. doi: 10.3892/etm.2018.6972. Epub 2018 Nov 15.
PubMed 30651867Irvine EJ, Zhou Q, Thompson AK. The Short Inflammatory Bowel Disease Questionnaire: a quality of life instrument for community physicians managing inflammatory bowel disease. CCRPT Investigators. Canadian Crohn's Relapse Prevention Trial. Am J Gastroenterol. 1996 Aug;91(8):1571-8.
PubMed 8759664Kanji T, Gandhi M, Clase CM, Yang R. Urate lowering therapy to improve renal outcomes in patients with chronic kidney disease: systematic review and meta-analysis. BMC Nephrol. 2015 Apr 19;16:58. doi: 10.1186/s12882-015-0047-z.
PubMed 25928556Kim YE, Ahn SM, Oh JS, Kim YG, Lee CK, Yoo B, Hong S. Febuxostat dose requirement according to renal function in patients who achieve target serum urate levels: A retrospective cohort study. Joint Bone Spine. 2024 Mar;91(2):105668. doi: 10.1016/j.jbspin.2023.105668. Epub 2023 Nov 29.
PubMed 38036062Kobayashi T, Siegmund B, Le Berre C, Wei SC, Ferrante M, Shen B, Bernstein CN, Danese S, Peyrin-Biroulet L, Hibi T. Ulcerative colitis. Nat Rev Dis Primers. 2020 Sep 10;6(1):74. doi: 10.1038/s41572-020-0205-x.
PubMed 32913180Sarhan II, Abdellatif YA, Saad RE, Teama NM. Renoprotective effect of febuxostat on contrast-induced acute kidney injury in chronic kidney disease patients stage 3: randomized controlled trial. BMC Nephrol. 2023 Mar 22;24(1):65. doi: 10.1186/s12882-023-03114-4.
PubMed 36949408Sloka J, Madej M, Strzalka-Mrozik B. Molecular Mechanisms of the Antitumor Effects of Mesalazine and Its Preventive Potential in Colorectal Cancer. Molecules. 2023 Jun 29;28(13):5081. doi: 10.3390/molecules28135081.
PubMed 37446747Solitano V, D'Amico F, Fiorino G, Paridaens K, Peyrin-Biroulet L, Danese S. Key Strategies to Optimize Outcomes in Mild-to-Moderate Ulcerative Colitis. J Clin Med. 2020 Sep 8;9(9):2905. doi: 10.3390/jcm9092905.
PubMed 32911840Sturm A, Maaser C, Calabrese E, Annese V, Fiorino G, Kucharzik T, Vavricka SR, Verstockt B, van Rheenen P, Tolan D, Taylor SA, Rimola J, Rieder F, Limdi JK, Laghi A, Krustins E, Kotze PG, Kopylov U, Katsanos K, Halligan S, Gordon H, Gonzalez Lama Y, Ellul P, Eliakim R, Castiglione F, Burisch J, Borralho Nunes P, Bettenworth D, Baumgart DC, Stoker J; European Crohn's and Colitis Organisation [ECCO] and the European Society of Gastrointestinal and Abdominal Radiology [ESGAR]. ECCO-ESGAR Guideline for Diagnostic Assessment in IBD Part 2: IBD scores and general principles and technical aspects. J Crohns Colitis. 2019 Mar 26;13(3):273-284. doi: 10.1093/ecco-jcc/jjy114. No abstract available.
PubMed 30137278
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Possible Efficacy and Safety of Febuxostat in Patients With Ulcerative Colitis Treated With Mesalamine
- ClinicalTrials.gov ID
- NCT06525974
- Acronym / sponsor ID
- MS.24.04.2758
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative Colitis, Febuxostat, Mesalamine
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 29 Jul 2024 (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.
Evaluation the possible efficacy and safety of febuxostat in patients with ulcerative colitis treated with mesalamine.
Detailed description
Ulcerative colitis (UC) is a sub-category of inflammatory bowel diseases (IBD) that causes mucosal inflammation in the rectum and lower colon. Although the exact pathogenesis of ulcerative colitis remains unclear, potential risk factors include altered immune responses, overactive immune response toward commensal microflora, genetic susceptibility, and environmental factors that have been considered as potential risk factors for UC .
The pathogenesis of UC consists of immuno-inflammatory pathways related to the multiple components of the intestine, including the epithelial barrier, dysregulation of immunological responses, leukocyte recruitment, and genetic factors. The understanding of immuno-inflammatory pathways of UC might lead to the development of a specific therapy and/or a novel treatment that could be more efficient .
Mesalazine (also known as mesalamine or 5- amino salicylic acid, 5-ASA) has a well-established role in UC management. It is the first line therapy for mild to moderate UC and it is considered the cornerstone in the management of UC. The mechanism of action of mesalazine is diverse. It acts locally on colonic mucosa and reduces inflammation by several anti-inflammatory processes .
Febuxostat (FXT) is a medication used in management hyperuricemia espicially in gout, a condition characterized by joints pain as result of deposition of uric acid crystals due to elevated urate blood levels. It's a non-purine selective xanthine oxidase inhibitor. Xanthin oxidase is an enzyme that plays a main role in production of uric acid from xanthine and hypoxanthine.
Furthermore, there is no need for dose modification of FXT in case of renal impairment and so it's great choice for many patients as it may exhibit renal protective effect and delay progression of kidney injury and according to Zhou H et al. FXT appears to be well tolerated in healthy population who has normal serum uric acid levels with no serious adverse events were reported .
Lately, febuxostat's spectrum of use has expanded over hyperuricemia management as result of it's ability of amelioration oxidative stress and regulation inflammatory response due to pro -inflammatory cytokines modulation.
Keyvan Amirshahrokhi and El-Mahdy NA et al. inspected the potential of FXT in mitigating ulcerative colitis in mice. The findings from those studies suggest that febuxostat may exert anti- inflammatory effects in the context of ulcerative colitis. Febuxostat's anti- inflammatory effects in ulcerative colitis may be linked to its inhibition of the nuclear factor kappa B (NF-κB) signaling pathway, a key regulator of inflammation. This inhibition can reduce the production of proinflammatory cytokines, contributing to its anti-inflammatory properties .
Although, preclinical studies in animal models are promising, translating these results into clinical applications is necessary to evaluate the safety and efficacy of FXT in managing UC in human.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group (Mesalamine group) | Active comparator | Drug: MesalamineControl group (Mesalamine group, n =23) who will receive 1 g mesalamine three times daily for 3 months. |
| Experimental group (Febuxostat group) | Experimental | Drug: FebuxostatExperimental group (Febuxostat group, n = 23) which will receive the standard treatment for UC plus 40 mg febuxostat once daily for 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years old.
- Both male and female will be included.
- Mild and moderate UC patients diagnosed and confirmed by endoscope.
- Patient treated with 5-aminosalislic acid (mesalamine).
Key exclusion criteria (16 listed)
- Patients with severe UC.
- Significant liver and kidney function abnormalities.
- Diabetic patients.
- Patients with Colorectal cancer patients.
- Patients taking rectal or systemic steroids.
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 |
|---|---|---|
| Febuxostat40mg of Febuxostat once daily | Drug | Experimental group (Febuxostat group) |
| Mesalamine1 g mesalamine three times daily for 3 months. | Drug | Control group (Mesalamine group) |
Primary outcome
Assessment of disease activity using Partial Mayo Scoring Index (PMSI) assessment for Ulcerative Colitis Activity.
Time frame: 3 months
It depends on three items: stool frequency, rectal bleeding (blood in stool) and Physician's Global Assessment. Each item has a score from 0 to 3 and total PMSI is the sum of scores for the three items.
Health-related quality of life (HRQOL) using the short inflammatory bowel disease questionnaire .
Time frame: 3 months
Short Inflammatory Bowel Disease Ques-tionnaire (SIBDQ) version became widely known and is currently used worldwide both in clinical practice and clinical research. SIBDQ comprises a total of 10 questions grouped into four different dimensions: social, bowel, emotional, and systemic [6, 7]. Each question is scored by a 7-point Likert scale, ranging from 1 (a severe problem) to 7 (not a problem at all), giving an absolute SIBDQ score ranging from 10 (poor HRQoL) to 70 (opti-mal HRQoL). A SIBDQ score below 50 was considered as poor QoL.there are no validated cut-offs for the dif-ferent dimensions' scores. Hence, higher scores indicate a better HRQoL concerning that specific domain.Although patient-reported outcomes are highly valu-able for better patient care, patient responses to HRQoL instruments can be impacted by underlying cultural trends
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Background: PubMed 37689273Abdel-Wahab BA, El-Shoura EAM, Shafiuddin Habeeb M, Zafaar D. Febuxostat alleviates Arsenic Trioxide-Induced renal injury in Rats: Insights on the crosstalk between NLRP3/TLR4, Sirt-1/NF-kappaB/TGF-beta signaling Pathways, and miR-23b-3p, miR-181a-5b expression. Biochem Pharmacol. 2023 Oct;216:115794. doi: 10.1016/j.bcp.2023.115794. Epub 2023 Sep 7.
- Background: PubMed 31499267Amirshahrokhi K. Febuxostat attenuates ulcerative colitis by the inhibition of NF-kappaB, proinflammatory cytokines, and oxidative stress in mice. Int Immunopharmacol. 2019 Nov;76:105884. doi: 10.1016/j.intimp.2019.105884. Epub 2019 Sep 6.
- Background: PubMed 33435164Cicero AFG, Fogacci F, Kuwabara M, Borghi C. Therapeutic Strategies for the Treatment of Chronic Hyperuricemia: An Evidence-Based Update. Medicina (Kaunas). 2021 Jan 10;57(1):58. doi: 10.3390/medicina57010058.
- Background: PubMed 31654756El-Mahdy NA, Saleh DA, Amer MS, Abu-Risha SE. Role of allopurinol and febuxostat in the amelioration of dextran-induced colitis in rats. Eur J Pharm Sci. 2020 Jan 1;141:105116. doi: 10.1016/j.ejps.2019.105116. Epub 2019 Oct 23.
- Background: PubMed 34030558Elsisi AEE, Sokar SS, Shalaby MF, Abu-Risha SE. Nephroprotective effects of febuxostat and/or mirtazapine against gentamicin-induced nephrotoxicity through modulation of ERK 1/2, NF-kappaB and MCP1. Expert Rev Clin Pharmacol. 2021 Aug;14(8):1039-1050. doi: 10.1080/17512433.2021.1933435. Epub 2021 Jun 9.
- Background: PubMed 25913922Fukui T, Maruyama M, Yamauchi K, Yoshitaka S, Yasuda T, Abe Y. Effects of Febuxostat on Oxidative Stress. Clin Ther. 2015 Jul 1;37(7):1396-401. doi: 10.1016/j.clinthera.2015.03.026. Epub 2015 Apr 23.
- Background: PubMed 30651867Hao G, Duan W, Sun J, Liu J, Peng B. Effects of febuxostat on serum cytokines IL-1, IL-4, IL-6, IL-8, TNF-alpha and COX-2. Exp Ther Med. 2019 Jan;17(1):812-816. doi: 10.3892/etm.2018.6972. Epub 2018 Nov 15.
- Background: PubMed 8759664Irvine EJ, Zhou Q, Thompson AK. The Short Inflammatory Bowel Disease Questionnaire: a quality of life instrument for community physicians managing inflammatory bowel disease. CCRPT Investigators. Canadian Crohn's Relapse Prevention Trial. Am J Gastroenterol. 1996 Aug;91(8):1571-8.
- Background: PubMed 25928556Kanji T, Gandhi M, Clase CM, Yang R. Urate lowering therapy to improve renal outcomes in patients with chronic kidney disease: systematic review and meta-analysis. BMC Nephrol. 2015 Apr 19;16:58. doi: 10.1186/s12882-015-0047-z.
- Background: PubMed 38036062Kim YE, Ahn SM, Oh JS, Kim YG, Lee CK, Yoo B, Hong S. Febuxostat dose requirement according to renal function in patients who achieve target serum urate levels: A retrospective cohort study. Joint Bone Spine. 2024 Mar;91(2):105668. doi: 10.1016/j.jbspin.2023.105668. Epub 2023 Nov 29.
- Background: PubMed 32913180Kobayashi T, Siegmund B, Le Berre C, Wei SC, Ferrante M, Shen B, Bernstein CN, Danese S, Peyrin-Biroulet L, Hibi T. Ulcerative colitis. Nat Rev Dis Primers. 2020 Sep 10;6(1):74. doi: 10.1038/s41572-020-0205-x.
- Background: PubMed 36949408Sarhan II, Abdellatif YA, Saad RE, Teama NM. Renoprotective effect of febuxostat on contrast-induced acute kidney injury in chronic kidney disease patients stage 3: randomized controlled trial. BMC Nephrol. 2023 Mar 22;24(1):65. doi: 10.1186/s12882-023-03114-4.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Febuxostat and Mesalamine in people with Ulcerative Colitis, run by Tanta University.
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 4 inclusion and 16 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: opening soon, as of the sponsor's last update on 29 Jul 2024. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdelrahman Mohammed Elkabbary Hasan Diab (01102400485 ext. 002, alabbary99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of disease activity using Partial Mayo Scoring Index (PMSI) assessment for Ulcerative Colitis Activity. (time frame: 3 months). The study lists 2 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 NCT06525974, which also lists 17 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 29 Jul 2024.