IBD - Inflammatory Bowel DiseaseNCT06814392
Renal and Urinary Manifestations of Chronic Inflammatory Bowel Diseases.
An observational study of IBD - Inflammatory Bowel Disease, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
The association between IBD and kidney diseases is more common than previously thought. However, the data is limited and comes from studies with small sample sizes. The proposed study aims to investigate this association in a large population of patients with IBD, assessing risk factors and potential changes in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IBD - Inflammatory Bowel Disease
- How many people
- 1,600 participants
- Where
- 1 siteItaly
- Study dates
- 20 Oct 2021to 31 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Chronic Inflammatory Bowel Diseases who have been followed at the SSD Chronic Inflammatory Bowel Diseases center. For patients with a diagnosis of kidney disease still affiliated with the center, data collection will be conducted prospectively for a period of 3 years from enrollment in the study.
Who may be able to join
- Signed informed consent
- Age ≥ 18 years
- Diagnosis of Crohn's Disease or Ulcerative Colitis
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Renal and Urinary Manifestations of Chronic Inflammatory Bowel Diseases: Prevalence, Risk Factors, and Prevention of Kidney Diseases in Patients With IBD, and Management of Transplant Patients.
The association between IBD and kidney diseases is more common than previously thought. However, the data is limited and comes from studies with small sample sizes. The proposed study aims to investigate this association in a large population of patients with IBD, assessing risk factors and potential changes in the therapeutic approach to minimize the risk of kidney damage.
The primary objective of this study is to characterize the association between IBD and kidney diseases, as well as the progression of intestinal disease and kidney function in patients who have undergone transplantation.
The study is monocentric, observational, and both retrospective and prospective.
Read the detailed description
All patients who agree to participate in the study and sign the informed consent will be asked to allow the collection of their clinical data for database compilation. Retrospective data will be evaluated and collected from the medical records of all patients with Chronic Inflammatory Bowel Diseases followed at the SSD Chronic Inflammatory Bowel Diseases center. For patients with a diagnosis of kidney disease still affiliated with the center, prospective data collection will occur for a period of 3 years from enrollment in the study. No additional study-specific analyses or procedures are planned.
- Sample Size Approximately 1500 patients with Chronic Inflammatory Bowel Diseases are expected to be enrolled.
- Statistical Analysis All analyses will be performed using Stata 13.0 for Windows. The characteristics of the enrolled and observed patients will be summarized using descriptive statistics. All variables will be summarized with descriptive statistical analyses. For qualitative variables: relative frequency and 95% confidence intervals; for quantitative variables: mean, standard deviation, and percentiles. To detect possible associations between observed qualitative characteristics, Pearson's Chi-square test will be used, along with Yates' continuity correction or Fisher's exact test. Analysis of variance (ANOVA) or analysis of covariance (ANCOVA) will be used for quantitative variables.
Statistical analysis will be conducted using the Stats package. Differences between groups will be evaluated with Student's t-test and uni- and multivariate analyses to identify risk factors.
- Conditions
- IBD - Inflammatory Bowel Disease
- Medical subject headings
- Inflammatory Bowel Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to characterize the association between IBD and kidney diseases, as well as the progression of intestinal disease and kidney function in patients who have undergone transplantation.
Assess the prevalence of kidney diseases in a large population of patients with IBD; Evaluate the course of IBD and the outcomes of kidney transplantation; Identify potential risk factors for the development of kidney diseases.
Measured: From enrollment to the end of study at 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start20 Oct 2021
- Primary completion1 Feb 2022
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBD - Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Other
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fernando Rizzello, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814392
- Sponsor's protocol ID
- I-RENE
- Status last verified
- Oct 2024
- First submitted
- 10 Jan 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal and Urinary Manifestations of Chronic Inflammatory Bowel Diseases: Prevalence, Risk Factors, and Prevention of Kidney Diseases in Patients With IBD, and Management of Transplant Patients.
- ClinicalTrials.gov ID
- NCT06814392
- Acronym / sponsor ID
- I-RENE
- Conditions
- IBD - Inflammatory Bowel Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Feb 2025 (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.
The association between IBD and kidney diseases is more common than previously thought. However, the data is limited and comes from studies with small sample sizes. The proposed study aims to investigate this association in a large population of patients with IBD, assessing risk factors and potential changes in the therapeutic approach to minimize the risk of kidney damage.
The primary objective of this study is to characterize the association between IBD and kidney diseases, as well as the progression of intestinal disease and kidney function in patients who have undergone transplantation.
The study is monocentric, observational, and both retrospective and prospective.
Detailed description
All patients who agree to participate in the study and sign the informed consent will be asked to allow the collection of their clinical data for database compilation. Retrospective data will be evaluated and collected from the medical records of all patients with Chronic Inflammatory Bowel Diseases followed at the SSD Chronic Inflammatory Bowel Diseases center. For patients with a diagnosis of kidney disease still affiliated with the center, prospective data collection will occur for a period of 3 years from enrollment in the study. No additional study-specific analyses or procedures are planned.
- Sample Size Approximately 1500 patients with Chronic Inflammatory Bowel Diseases are expected to be enrolled.
- Statistical Analysis All analyses will be performed using Stata 13.0 for Windows. The characteristics of the enrolled and observed patients will be summarized using descriptive statistics. All variables will be summarized with descriptive statistical analyses. For qualitative variables: relative frequency and 95% confidence intervals; for quantitative variables: mean, standard deviation, and percentiles. To detect possible associations between observed qualitative characteristics, Pearson's Chi-square test will be used, along with Yates' continuity correction or Fisher's exact test. Analysis of variance (ANOVA) or analysis of covariance (ANCOVA) will be used for quantitative variables.
Statistical analysis will be conducted using the Stats package. Differences between groups will be evaluated with Student's t-test and uni- and multivariate analyses to identify risk factors.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Chronic Inflammatory Bowel Diseases who have been followed at the SSD Chronic Inflammatory Bowel Diseases center. For patients with a diagnosis of kidney disease still affiliated with the center, data collection will be conducted prospectively for a period of 3 years from enrollment in the study.
Key inclusion criteria (3 listed)
- Signed informed consent
- Age ≥ 18 years
- Diagnosis of Crohn's Disease or Ulcerative Colitis
Key exclusion criteria (1 listed)
- None
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
The primary objective of this study is to characterize the association between IBD and kidney diseases, as well as the progression of intestinal disease and kidney function in patients who have undergone transplantation.
Time frame: From enrollment to the end of study at 3 years
Assess the prevalence of kidney diseases in a large population of patients with IBD; Evaluate the course of IBD and the outcomes of kidney transplantation; Identify potential risk factors for the development of kidney diseases.
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 7 Feb 2025.
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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.
Fernando Rizzello, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IBD - Inflammatory Bowel Disease, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 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: under way, not looking for participants, as of the sponsor's last update on 7 Feb 2025. 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 Italy. 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.
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?
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 objective of this study is to characterize the association between IBD and kidney diseases, as well as the progression of intestinal disease and kidney function in patients who have undergone transplantation. (time frame: From enrollment to the end of study at 3 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 7 Feb 2025.