Nephrolithiasis, Glomerulonephritis, Amyloidosis,AKI, CKD, Tubuli InterstitialNCT06249243
Affection of Renal and Urinary System in IBD Patients
An observational study of Nephrolithiasis, Glomerulonephritis, Amyloidosis,AKI, CKD, Tubuli Interstitial and Urinary System Disorders in IBD Patients, run by Assiut University.
Trial summary
Detection and classification of different renal and urinary affection in patients with IBD that attended to Assist University Hospitals Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nephrolithiasis, Glomerulonephritis, Amyloidosis,AKI, CKD, Tubuli Interstitial, Urinary System Disorders in IBD Patients
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2024to 25 Oct 2026
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Sample size was calculated by using it open -epi version 3 According to the prevalence of urinary affection in IBD patients 13,5%() Sample size was 92 patient at confidance level 95% +-7 confidance limit
Who may be able to join
- 100 patients suffering of IBD who attended to AUH either with Crohn's or ulcerative colitis with different presentation
Who cannot join
- Patients with other known cause of kidney or urinary affection as DM,HTN,APCKD, lupus nephritis,UTI…..
Trial locations and contacts
No sites are listed yet.
Mohamed Hassan, Staff doctor contact
About this study
Official title: Patterns of Renal & Urinary Involvement in Patients With Inflammatory Bowel Diseases Who Attended to Assiut University Hospitals
Detection and classification of different renal and urinary affection in patients with IBD that attended to Assist University Hospitals
Read the detailed description
Background (Research Question, Available Data from the literature, Current strategy for dealing with the problem, Rationale of the research that paves the way to the aim(s) of the work). (200-250 words max.) Inflammatory bowel disease is an idiopathic disease cause sever inflammation of GIT , presentes in ulcerative colitis or Crohn's disease occur in 6%-47%
IBD is profoundly associated with extra intestinal manifestions , Especially renal and urinary involvement occurs in 4% - 23% of patients with IBD.
Patterns of renal complications include nephrolithiasis, glomerulonephritis, amyloidosis, AKl, CKD, tubulointerstitial nephritis, asymptomatic proteinuria and hematuria; each type has specific mechanism
Nephrolithiasis is 10-100 times greater in IBD patients than general population.most common stones are calcium, oxalate and urate; Stones occur due to loss of electrolytes "Mg,k" due to diarrhea which lead to crystallization.
Glomerulonephritis pattern in IBD , is associated with IgA nephropathy, IgM nephropathy, membranous and focal segmental glomerulonephritis.
There is genetic connection between IgA nephropathy and intestinal diseases!
Secondary amyloidosis (AA-type) is a rare but serious complication of IBD.renal amyloidosis had been proven to be the most common lethal manifestion of IBD - associated amyloidosis (A), since renal involvement rapidly leads to end stage renal failure.
Sever long -standing IBD consists a predisposing factor for renal complications that occur in 4-23 % of patients So we aim to shed more light on the pathophysiology of renal damage in IBD; considering the renal manifestions and complications of IBD, it is important to emphasize the role of screening of renal function in preventing, diagnosing, and,if possible, reversing probable kidney damage.
- Conditions
- Nephrolithiasis, Glomerulonephritis, Amyloidosis,AKI, CKD, Tubuli Interstitial, Urinary System Disorders in IBD Patients
- Medical subject headings
- Nephrolithiasis, Glomerulonephritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Patterns of renal and urinary involvement in IBD patients
Is renal and urinary system affect on IBD patients ?
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start20 Aug 2024 (estimated)
- Primary completion25 Sep 2026 (estimated)
- Study completion25 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephrolithiasis, Glomerulonephritis, Amyloidosis,AKI, CKD, Tubuli InterstitialStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Essam Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249243
- Sponsor's protocol ID
- Renal and urinary in IBD
- Status last verified
- Jul 2024
- First submitted
- 9 Dec 2023
- Last updated
- 30 Jul 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patterns of Renal & Urinary Involvement in Patients With Inflammatory Bowel Diseases Who Attended to Assiut University Hospitals
- ClinicalTrials.gov ID
- NCT06249243
- Acronym / sponsor ID
- Renal and urinary in IBD
- Conditions
- Nephrolithiasis, Glomerulonephritis, Amyloidosis,AKI, CKD, Tubuli Interstitial, Urinary System Disorders in IBD Patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Aug 2024 (estimated)
- Primary completion
- 25 Sep 2026 (estimated)
- Study completion
- 25 Oct 2026 (estimated)
- First posted
- 8 Feb 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.
Detection and classification of different renal and urinary affection in patients with IBD that attended to Assist University Hospitals
Detailed description
Background (Research Question, Available Data from the literature, Current strategy for dealing with the problem, Rationale of the research that paves the way to the aim(s) of the work). (200-250 words max.) Inflammatory bowel disease is an idiopathic disease cause sever inflammation of GIT , presentes in ulcerative colitis or Crohn's disease occur in 6%-47%
IBD is profoundly associated with extra intestinal manifestions , Especially renal and urinary involvement occurs in 4% - 23% of patients with IBD.
Patterns of renal complications include nephrolithiasis, glomerulonephritis, amyloidosis, AKl, CKD, tubulointerstitial nephritis, asymptomatic proteinuria and hematuria; each type has specific mechanism
Nephrolithiasis is 10-100 times greater in IBD patients than general population.most common stones are calcium, oxalate and urate; Stones occur due to loss of electrolytes "Mg,k" due to diarrhea which lead to crystallization.
Glomerulonephritis pattern in IBD , is associated with IgA nephropathy, IgM nephropathy, membranous and focal segmental glomerulonephritis.
There is genetic connection between IgA nephropathy and intestinal diseases!
Secondary amyloidosis (AA-type) is a rare but serious complication of IBD.renal amyloidosis had been proven to be the most common lethal manifestion of IBD - associated amyloidosis (A), since renal involvement rapidly leads to end stage renal failure.
Sever long -standing IBD consists a predisposing factor for renal complications that occur in 4-23 % of patients So we aim to shed more light on the pathophysiology of renal damage in IBD; considering the renal manifestions and complications of IBD, it is important to emphasize the role of screening of renal function in preventing, diagnosing, and,if possible, reversing probable kidney damage.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Sample size was calculated by using it open -epi version 3 According to the prevalence of urinary affection in IBD patients 13,5%() Sample size was 92 patient at confidance level 95% +-7 confidance limit
Key inclusion criteria (1 listed)
- 100 patients suffering of IBD who attended to AUH either with Crohn's or ulcerative colitis with different presentation
Key exclusion criteria (1 listed)
- Patients with other known cause of kidney or urinary affection as DM,HTN,APCKD, lupus nephritis,UTI…..
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
Patterns of renal and urinary involvement in IBD patients
Time frame: 2 years
Is renal and urinary system affect on IBD patients ?
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
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.
Mohamed Hassan, Staff doctor contact
Questions about this trial
What is this clinical trial studying?
An observational study of Nephrolithiasis, Glomerulonephritis, Amyloidosis,AKI, CKD, Tubuli Interstitial and Urinary System Disorders in IBD Patients, 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 1 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: status not confirmed, as of the sponsor's last update on 30 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rania Essam, Researcher (01285082769, re2677440@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patterns of renal and urinary involvement in IBD patients (time frame: 2 years). 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 30 Jul 2024.