Renal and Urinary Manifestations of Chronic Inflammatory Bowel Diseases.

NCT06814392 | Active Not Recruiting

• 1 other identifier: I-RENE
• Study Type: observational
• Target: 1,600
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

IBD - Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of study at 3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Signed informed consent
• Age ≥ 18 years
• Diagnosis of Crohn's Disease or Ulcerative Colitis

You may not qualify if:

• None

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Fernando Rizzello, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: February 7, 2025
• Study Start: October 20, 2021
• Primary Completion: February 1, 2022
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 7, 2025

Record last verified: 2024-10

Locations

IT (1)