IBD and Renal InvolementNCT06717516
Renal Involvement in Adult Patients With Inflammatory Bowel Disease and Its Relation to Duration and Disease Activity
An observational study of IBD and Renal Involement and IBD Activity and Kidney Affection, run by Assiut University.
Trial summary
To Assess the pattern of renal injury in patients with inflammatory bowel disease and its relation to the duration and disease activity by Identification and characterization of early renal manifestations (e.g., proteinuria, hematuria, electrolyte imbalances) in IBD patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- IBD and Renal Involement, IBD Activity and Kidney Affection
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to Jan 2026
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 18 years or older with Confirmed diagnosis of IBD either crohns disease or ulcerative colities based on clinical ,endoscopic ,histological and radiological findings
Who may be able to join
- Adults aged 18 years or older
- Confirmed diagnosis of IBD either crohns disease or ulcerative colities based on clinical ,endoscopic ,histological and radiological findings . - Patients in any stage of IBD, including remission, active disease, and flare-ups. - Willingness to participate and provide informed consent. - Renal Assessment for participants.
Who cannot join
- Pre-existing chronic kidney disease (CKD) at any stage. - Known primary kidney diseases unrelated to IBD. - Current use of nephrotoxic medications not related to IBD treatment. - Pregnancy or breastfeeding. - Patients who are unable to comply with study protocols or follow-up assessment - Presence of other significant comorbidities that impact renal function or overall health
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
Official title: Renal Involvement in Adult Patients With Inflammatory Bowel Disease and Its Relation to Duration and Disease Activity .
To Assess the pattern of renal injury in patients with inflammatory bowel disease and its relation to the duration and disease activity by Identification and characterization of early renal manifestations (e.g., proteinuria, hematuria, electrolyte imbalances) in IBD patients. and know Correlation between kidney involvement and IBD severity, including flare-ups and complications.
and know Impact of early renal manifestations on long-term renal outcomes, such as progression to CKD or development of AKI.
Read the detailed description
Inflammatory bowel disease (IBD), comprising ulcerative colitis (UC) and Crohn's disease (CD), is a chronic immunemediated disorder of the gastro-intestinal tract characterized by recurrent inflammation and epithelial injury of the intestine. Extraintestinal manifestations are seen in 6% to 47% of patients diagnosed with IBD. Renal and urinary tract involvement occurs in 4% to 23% of patients with IBD, with renal calculi being the most common form of renal involvement. IBD is associated with a range of renal manifestations, including nephrolithiasis, glomerulonephritis, tubulointerstitial nephritis, and secondary amyloidosis, which can lead to acute or chronic renal insufficiency. Several potential mechanisms might contribute to the higher risk of incident CKD and AKI in patients with IBD. First, in the context of IBD, acute or chronic loss of circulating volume (salt and water depletion) due to persistent inflammation of the intestine and repeated intestinal resection could lead to electrolyte abnormalities followed by acute and chronic loss of kidney function, which may not be always reversible. Second, dysbiosis in patients with IBD is associated with increased production of microbiota-derived uremic toxins and microinflammation, both of which promote the progression of renal diseases. Third, IBD-related alterations in the innate and adaptive immune systems may lead to elevated proinflammatory cytokines, which are particularly implicated in the progression of renal disease. Understanding these associations is crucial for management and monitoring of IBD patients, particularly for those who may develop renal complications, so mitigating impact on kidney function and overall health.
- Keywords
- IBD and kidney
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of renal manifestations in IBD patients and Correlation between kidney involvement and IBD severity, including flare-ups and complications and its Impact on long-term renal outcomes, such as progression to CKD or development of AKI
Identification and characterization of renal manifestations (e.g., proteinuria, hematuria, electrolyte imbalances) in IBD patients and Correlation between kidney involvement and IBD severity, including flare-ups and complications and Impact of early renal manifestations on long-term renal outcomes, such as progression to CKD or development of AKI
Measured: scheduled follow-ups at 3,6,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start1 Dec 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for IBD and Renal InvolementStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Abdel-Aal Khalifa Abdel-Aal, Assiut University
- Investigators
- Effat AbdelHady Tony Ahmed, Study chairMohammed Abdelhakim Elmahdy, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717516
- Sponsor's protocol ID
- Renal inolvement in adult IBD
- Status last verified
- Nov 2024
- First submitted
- 30 Nov 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lian X, Wang Y, Wang S, Peng X, Wang Y, Huang Y, Chen W. Does inflammatory bowel disease promote kidney diseases: a mendelian randomization study with populations of European ancestry. BMC Med Genomics. 2023 Sep 26;16(1):225. doi: 10.1186/s12920-023-01644-2.
PubMed 37752523Evenepoel P, Poesen R, Meijers B. The gut-kidney axis. Pediatr Nephrol. 2017 Nov;32(11):2005-2014. doi: 10.1007/s00467-016-3527-x. Epub 2016 Nov 15.
PubMed 27848096Kumar S, Pollok R, Goldsmith D. Renal and Urological Disorders Associated With Inflammatory Bowel Disease. Inflamm Bowel Dis. 2023 Aug 1;29(8):1306-1316. doi: 10.1093/ibd/izac140.
PubMed 35942657Kellum JA, Romagnani P, Ashuntantang G, Ronco C, Zarbock A, Anders HJ. Acute kidney injury. Nat Rev Dis Primers. 2021 Jul 15;7(1):52. doi: 10.1038/s41572-021-00284-z.
PubMed 34267223van Hoeve K, Hoffman I. Renal manifestations in inflammatory bowel disease: a systematic review. J Gastroenterol. 2022 Sep;57(9):619-629. doi: 10.1007/s00535-022-01903-6. Epub 2022 Jul 14.
PubMed 35834005Piovani D, Danese S, Peyrin-Biroulet L, Bonovas S. Environmental, Nutritional, and Socioeconomic Determinants of IBD Incidence: A Global Ecological Study. J Crohns Colitis. 2020 Mar 13;14(3):323-331. doi: 10.1093/ecco-jcc/jjz150.
PubMed 31504350
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Involvement in Adult Patients With Inflammatory Bowel Disease and Its Relation to Duration and Disease Activity .
- ClinicalTrials.gov ID
- NCT06717516
- Acronym / sponsor ID
- Renal inolvement in adult IBD
- Keywords
- IBD and kidney
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 5 Dec 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.
To Assess the pattern of renal injury in patients with inflammatory bowel disease and its relation to the duration and disease activity by Identification and characterization of early renal manifestations (e.g., proteinuria, hematuria, electrolyte imbalances) in IBD patients. and know Correlation between kidney involvement and IBD severity, including flare-ups and complications.
and know Impact of early renal manifestations on long-term renal outcomes, such as progression to CKD or development of AKI.
Detailed description
Inflammatory bowel disease (IBD), comprising ulcerative colitis (UC) and Crohn's disease (CD), is a chronic immunemediated disorder of the gastro-intestinal tract characterized by recurrent inflammation and epithelial injury of the intestine. Extraintestinal manifestations are seen in 6% to 47% of patients diagnosed with IBD. Renal and urinary tract involvement occurs in 4% to 23% of patients with IBD, with renal calculi being the most common form of renal involvement. IBD is associated with a range of renal manifestations, including nephrolithiasis, glomerulonephritis, tubulointerstitial nephritis, and secondary amyloidosis, which can lead to acute or chronic renal insufficiency. Several potential mechanisms might contribute to the higher risk of incident CKD and AKI in patients with IBD. First, in the context of IBD, acute or chronic loss of circulating volume (salt and water depletion) due to persistent inflammation of the intestine and repeated intestinal resection could lead to electrolyte abnormalities followed by acute and chronic loss of kidney function, which may not be always reversible. Second, dysbiosis in patients with IBD is associated with increased production of microbiota-derived uremic toxins and microinflammation, both of which promote the progression of renal diseases. Third, IBD-related alterations in the innate and adaptive immune systems may lead to elevated proinflammatory cytokines, which are particularly implicated in the progression of renal disease. Understanding these associations is crucial for management and monitoring of IBD patients, particularly for those who may develop renal complications, so mitigating impact on kidney function and overall health.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18 years or older with Confirmed diagnosis of IBD either crohns disease or ulcerative colities based on clinical ,endoscopic ,histological and radiological findings
Key inclusion criteria (2 listed)
- Adults aged 18 years or older
- Confirmed diagnosis of IBD either crohns disease or ulcerative colities based on clinical ,endoscopic ,histological and radiological findings . - Patients in any stage of IBD, including remission, active disease, and flare-ups. - Willingness to participate and provide informed consent. - Renal Assessment for participants.
Key exclusion criteria (1 listed)
- Pre-existing chronic kidney disease (CKD) at any stage. - Known primary kidney diseases unrelated to IBD. - Current use of nephrotoxic medications not related to IBD treatment. - Pregnancy or breastfeeding. - Patients who are unable to comply with study protocols or follow-up assessment - Presence of other significant comorbidities that impact renal function or overall health
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of renal manifestations in IBD patients and Correlation between kidney involvement and IBD severity, including flare-ups and complications and its Impact on long-term renal outcomes, such as progression to CKD or development of AKI
Time frame: scheduled follow-ups at 3,6,12 months
Identification and characterization of renal manifestations (e.g., proteinuria, hematuria, electrolyte imbalances) in IBD patients and Correlation between kidney involvement and IBD severity, including flare-ups and complications and Impact of early renal manifestations on long-term renal outcomes, such as progression to CKD or development of AKI
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 5 Dec 2024.
- Results publication: PubMed 37752523Lian X, Wang Y, Wang S, Peng X, Wang Y, Huang Y, Chen W. Does inflammatory bowel disease promote kidney diseases: a mendelian randomization study with populations of European ancestry. BMC Med Genomics. 2023 Sep 26;16(1):225. doi: 10.1186/s12920-023-01644-2.
- Results publication: PubMed 27848096Evenepoel P, Poesen R, Meijers B. The gut-kidney axis. Pediatr Nephrol. 2017 Nov;32(11):2005-2014. doi: 10.1007/s00467-016-3527-x. Epub 2016 Nov 15.
- Results publication: PubMed 35942657Kumar S, Pollok R, Goldsmith D. Renal and Urological Disorders Associated With Inflammatory Bowel Disease. Inflamm Bowel Dis. 2023 Aug 1;29(8):1306-1316. doi: 10.1093/ibd/izac140.
- Results publication: PubMed 34267223Kellum JA, Romagnani P, Ashuntantang G, Ronco C, Zarbock A, Anders HJ. Acute kidney injury. Nat Rev Dis Primers. 2021 Jul 15;7(1):52. doi: 10.1038/s41572-021-00284-z.
- Results publication: PubMed 35834005van Hoeve K, Hoffman I. Renal manifestations in inflammatory bowel disease: a systematic review. J Gastroenterol. 2022 Sep;57(9):619-629. doi: 10.1007/s00535-022-01903-6. Epub 2022 Jul 14.
- Results publication: PubMed 31504350Piovani D, Danese S, Peyrin-Biroulet L, Bonovas S. Environmental, Nutritional, and Socioeconomic Determinants of IBD Incidence: A Global Ecological Study. J Crohns Colitis. 2020 Mar 13;14(3):323-331. doi: 10.1093/ecco-jcc/jjz150.
- Individual participant dataSharing planned: Undecided
Related trials for IBD and Renal Involement
RecruitingObservational study
Renal Dysfunction in Patients With Inflammatory Bowel Disease and the General Population (NEPHRO-IBD)
IBD and Renal Involement, Chronic Kidney Disease
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.
Effat AbdelHady Tony Ahmed study chair
Mohammed Abdelhakim Elmahdy study director
Questions about this trial
What is this clinical trial studying?
An observational study of IBD and Renal Involement and IBD Activity and Kidney Affection, run by Assiut 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 2 inclusion and 1 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 5 Dec 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.
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 Esraa Abdel-Aal Khalifa Abdel-Aal (+201021250942, Esraa.15235585@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of renal manifestations in IBD patients and Correlation between kidney involvement and IBD severity, including flare-ups and complications and its Impact on long-term renal outcomes, such as progression to CKD or development of AKI (time frame: scheduled follow-ups at 3,6,12 months). 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 NCT06717516, which also lists 6 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 5 Dec 2024.