Actively Recruiting

Age: 18Years - 80Years
All Genders
Healthy Volunteers
ID07593352

Renal Dysfunction in Adults With Inflammatory Bowel Disease Compared to the General Population The NEPHRO-IBD Observational Study

Led by Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji · Updated on 2026-05-18

6000

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

Sponsors

P

Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji

Lead Sponsor

P

Poznan University of Medical Sciences

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating how often kidney problems occur in adults with inflammatory bowel disease (IBD), such as Crohn's disease and ulcerative colitis, compared to adults without IBD. This observational study aims to better understand kidney complications in IBD patients, which are often overlooked despite being potentially serious. The study will include about 6,000 participants, half with confirmed IBD and half without, to serve as a control group. Participants will undergo regular clinical assessments including routine blood and urine tests, urinalysis with albumin-to-creatinine ratio measurement, and abdominal ultrasound to examine the kidneys and urinary tract. These tests will be repeated every three to six months. IBD patients will also have their disease activity measured using clinical indices like the Total Mayo Score and Crohn's Disease Activity Index, along with fecal calprotectin levels to assess inflammation. During the study, participants will complete questionnaires and undergo laboratory tests and imaging at baseline and follow-up visits approximately every three months, for up to six months. Researchers will track kidney function and assess links between kidney problems, IBD activity, treatments, and other health conditions. The main outcome is the prevalence of kidney dysfunction in IBD patients compared to the general population. The study will help improve early detection and management of kidney disease in people with IBD.

CONDITIONS

Brief Title

Renal Dysfunction in Patients With Inflammatory Bowel Disease and the General Population (NEPHRO-IBD)

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years and up to 80 years
  • Confirmed diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis) or no IBD for control group
  • Ability to provide consent to participate
  • Sufficient cognitive ability to complete questionnaires
Not Eligible

You will not qualify if you...

  • Diabetes
  • Symptoms suggestive of urinary tract infection
  • Women currently menstruating (urinalysis must be timed accordingly)
  • Refusal to participate in all study procedures
  • Age under 18 or over 80 years
  • Pregnancy
  • Serious other health conditions that may affect kidney tests
  • Previous surgeries that may affect kidney test results
  • Extreme physical exertion within 7 days before testing or intense strength training within 1 day before testing
  • Excessive alcohol use within 14 days before the study
  • Inability to complete required tests, including imaging
  • Incomplete data availability for registry-based participants
  • Dehydration
  • Use of nephrotoxic medications for 10 or more days within one month before or during the study
  • Use of angiotensin inhibitors, sartans, or flozins started less than 3 months before the study
  • Nephrotoxic drugs include NSAIDs (beyond occasional use), gold salts, penicillamine, interferon alpha, antituberculosis drugs, pamidronate, Biseptol, antiviral drugs, anticonvulsants, cyclosporine A, tacrolimus, Chinese herbs, and oncology drugs such as cisplatin

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Baseline assessment

Participants undergo routine clinical evaluation including blood and urine tests and abdominal ultrasound to assess kidney function and detect renal complications.

1 baseline visit (in-person)

Long-term Monitoring

Duration - Up to 6 months

Participants are monitored with routine blood and urine tests and abdominal ultrasound approximately every 3 months to evaluate renal function and inflammatory bowel disease activity over time.

Visits every 3 months

Trial Site Locations

Total: 1 location

1

National Medical Institute of the Ministry of the Interior and Administration, Clinic of Gastroenterology and Internal Diseases

Warsaw, Warszawa, Poland, 02-507

Actively Recruiting

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Research Team

K

Krzysztof Jaroń, MD, MPharm

K

Konrad Lewandowski, Associate/Assistant Professor

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Hepatitis C infection risk analysis: who should be screened? Comparison of multiple screening strategies based on the National Hepatitis Surveillance Program.

K L Lapane, A F Jakiche, D Sugano...

https://pubmed.ncbi.nlm.nih.gov/9576453