IBD and Renal InvolementNEPHRO-IBDNCT07593352
Renal Dysfunction in Patients With Inflammatory Bowel Disease and the General Population (NEPHRO-IBD)
An observational study of IBD and Renal Involement and Chronic Kidney Disease, run by Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji at 1 site in Poland.
Trial summary
The NEPHRO-IBD study is a multicenter prospective observational study designed to evaluate the prevalence of renal dysfunction and renal complications in adult patients with inflammatory bowel disease (IBD) compared with individuals from the general population. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- IBD and Renal Involement, Chronic Kidney Disease, Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis)
- What is being tested?
- Prospective assessment of the prevalence of kidney disease and/or renal complications in patients with IBD/the general population based on routine laboratory test and abdominal ultrasound.
- How many people
- 6,000 participants
- Where
- 1 sitePoland
- Study dates
- 20 Nov 2025to 30 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of adult participants recruited at multiple gastroenterology centers in Poland. The study will include approximately 6,000 individuals, including 3,000 patients with confirmed Inflammatory Bowel Disease (Crohn's disease or ulcerative colitis) and 3,000 individuals without IBD serving as a control group from the general population. Patients with IBD will be identified based on clinical evaluation and endoscopic confirmation of disease. Control participants will include adults without a diagnosis of inflammatory bowel disease who meet the study eligibility criteria. All participants will undergo clinical assessment, laboratory testing including blood tests and urinalysis with measurement of the albumin-to-creatinine ratio (ACR), and abdominal ultrasound evaluation of the kidneys and urinary tract. In patients with IBD, disease activity will additionally be assessed using validated clinical indices.
Who may be able to join
- Age over 18 years
- Confirmed IBD based on the overall clinical picture and endoscopic examination, or no IBD (control group without IBD)
- Consent to participate in the study
- Cognitive abilities sufficient to complete the questionnaires
Who cannot join
- diabetes
- dysuric symptoms suggestive of urinary tract infections
- in women, menstruation (urinalysis can be performed 3 days before the onset and 3 days after the end of menstruation)
- refusal to participate in all procedures performed in the study
- age under 18 or over 80
- pregnancy
Show all 27Show fewer
- other serious comorbidities whose presence or exacerbation may cause abnormalities in laboratory tests suggesting kidney disease
- previous surgery whose presence may cause abnormalities in laboratory tests suggesting kidney disease
- extreme physical exertion within 7 days before the test (marathons, half-marathons, triathlons) and intense physical exertion - strength training - within 1 day before the test. [moderate physical exertion such as walking, swimming, or cycling is not a contraindication]. • Excessive alcohol consumption 14 days before the study
- Inability to perform necessary tests: e.g., inability to perform an imaging test
- Unavailability of data: if the study is based on registry data, exclusion of individuals for whom there is incomplete data
- Dehydration
- Use of nephrotoxic medications* within a month before and during the study
- Use of angiotensin inhibitors, sartans, or flozins that were introduced into treatment within <3 months
- Nephrotoxic drugs:
- Nonsteroidal anti-inflammatory drugs (NSAIDs) - occasional use is not contraindicated, but use for ≥ 10 days is an exclusion criterion
- Gold salts
- Penicillamine
- Interferon alpha
- Antituberculosis drugs (rifampicin, ethambutol, isoniazid)
- Pamidronate
- Biseptol
- Antiviral drugs (acyclovir)
- Anticonvulsants (carbamazepine, diazepam, phenobarbital)
- Cyclosporine A, tacrolimus
- Chinese herbs
- Oncology drugs (cisplatin)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Konrad Lewandowski, Associate/Assistant Professor contact
Poland1 site, 1 recruiting
- Recruiting
National Medical Institute of the Ministry of the Interior and Administration, Clinic of Gastroenterology and Internal Diseases
Warsaw, Warszawa, 02-507
Grażyna Rydzewska, Professor, +48 477 22 12 40, grażyna.rydzewska@pimmswia.gov.pl
About this study
Official title: A Multicenter, Prospective, Observational Study Comparing the Prevalence of Renal Dysfunction in Adult Patient With Inflammatory Bowel Disease Between General Population: The NEPHRO-IBD Study.
The NEPHRO-IBD study is a multicenter prospective observational study designed to evaluate the prevalence of renal dysfunction and renal complications in adult patients with inflammatory bowel disease (IBD) compared with individuals from the general population. Although extraintestinal manifestations are common in IBD, renal involvement remains relatively underrecognized and insufficiently studied.
The study will recruit approximately 6,000 participants, including 3,000 patients with confirmed IBD (Crohn's disease or ulcerative colitis) and 3,000 individuals without IBD serving as a control group. Participants will undergo routine clinical assessment, including laboratory tests, urinalysis with measurement of the albumin-to-creatinine ratio (ACR), and imaging evaluation of the kidneys and urinary tract. Disease activity in patients with IBD will be assessed using validated clinical indices.
The study will also evaluate the relationship between renal dysfunction and disease activity, medications used in IBD treatment, and comorbidities. The results of this study are expected to improve the understanding of renal complications in patients with IBD and support earlier identification and management of kidney disease in this population.
Read the detailed description
Inflammatory bowel diseases (IBD), including Crohn's disease and ulcerative colitis, are chronic inflammatory disorders of the gastrointestinal tract that are frequently associated with extraintestinal manifestations. These manifestations may involve multiple organ systems, including the musculoskeletal, dermatologic, hepatobiliary, ocular, and renal systems. While several extraintestinal manifestations of IBD have been well described, renal complications remain relatively underrecognized and insufficiently investigated.
Renal manifestations associated with IBD may include nephrolithiasis, amyloidosis, tubulointerstitial nephritis, glomerulonephritis, urinary tract fistulas, and urothelial malignancies. In addition to disease-related mechanisms, potential contributing factors include immune dysregulation, genetic susceptibility, environmental factors, and nephrotoxic effects of medications used in the treatment of IBD, such as 5-aminosalicylates or thiopurines.
Previous studies suggest that patients with IBD may have an increased risk of chronic kidney disease (CKD) and acute kidney injury (AKI). However, the true prevalence and determinants of renal dysfunction in patients with IBD remain unclear due to limited prospective data.
The NEPHRO-IBD study is a multicenter prospective observational study designed to evaluate the prevalence of renal dysfunction and renal complications in adult patients with inflammatory bowel disease compared with individuals from the general population. Approximately 6,000 participants will be included, including 3,000 patients with confirmed IBD and 3,000 individuals without IBD serving as a control group.
Participants will undergo clinical assessment and routine laboratory testing at baseline and during follow-up visits performed at intervals of approximately three months. The evaluation will include blood tests, urinalysis with measurement of the urine albumin-to-creatinine ratio (ACR), and imaging assessment of the kidneys and urinary tract using abdominal ultrasound. In patients with IBD, disease activity will be evaluated using validated clinical indices, including the Total Mayo Score for ulcerative colitis and the Crohn's Disease Activity Index (CDAI). Fecal calprotectin levels will also be measured to assess intestinal inflammation.
The study will also investigate potential associations between renal abnormalities and inflammatory bowel disease activity, pharmacological treatment, and comorbid conditions. Early identification of renal dysfunction may facilitate timely nephrological evaluation and implementation of nephroprotective therapy in affected patients.
The results of the NEPHRO-IBD study are expected to improve understanding of renal involvement in inflammatory bowel disease and support the development of strategies for early detection and management of kidney disease in this population.
- Conditions
- IBD and Renal Involement, Chronic Kidney Disease, Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis)
- Being tested
- Prospective assessment of the prevalence of kidney disease and/or renal complications in patients with IBD/the general population based on routine laboratory test and abdominal ultrasound.
- Keywords
- IBD, Crohn's Disease, Ulcerative Colitis, Renal Dysfunction, Chronic Kidney Disease, Extraintestinal Manifestations, Renal Complications in IBD, Albumin-to-Creatinine Ratio
- Medical subject headings
- Renal Insufficiency, Chronic, Colitis, Ulcerative, Crohn Disease, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospective assessment of the prevalence of kidney disease and/or renal complications in patients with IBD/the general population based on routine laboratory test and abdominal ultrasound.Diagnostic test
No experimental intervention is performed. Participants undergo routine clinical evaluation, laboratory testing, urinalysis including albumin-to-creatinine ratio (ACR), and abdominal ultrasound as part of observational data collection.
| Study group | Role | What they receive |
|---|---|---|
| Study group: IBD patients | Routine blood and urine tests performed every 3 and 6 months: peripheral blood count, CRP, glucose, total cholesterol, LDL, HDL, TGL, sodium, potassium, magnesium, phosphorus, uric acid, vitamin D3, albumin, urea, creatinine, calprotectin, and urinalysis with creatinine/albumin ratio (ACR) assessment.
Assessment of the urinary system in abdominal ultrasound. Receives: Diagnostic Test: Prospective assessment of the prevalence of kidney disease and/or renal complications in patients with IBD/the general population based on routine laboratory test and abdominal ultrasound. | |
| Control group - patients without IBD | Routine blood and urine tests performed every 3 and 6 months: peripheral blood count, CRP, glucose, total cholesterol, LDL, HDL, TGL, sodium, potassium, magnesium, phosphorus, uric acid, vitamin D3, albumin, urea, creatinine, calprotectin, and urinalysis with creatinine/albumin ratio (ACR) assessment.
Assessment of the urinary system in abdominal ultrasound. Receives: Diagnostic Test: Prospective assessment of the prevalence of kidney disease and/or renal complications in patients with IBD/the general population based on routine laboratory test and abdominal ultrasound. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of renal dysfunction in patients with inflammatory bowel disease compared with the general population.
Evaluation of the association between the occurrence of kidney disease and IBD activity (including measurement of fecal calprotectin levels), as well as medications used and comorbidities.
Measured: Baseline and up to 6 months of follow-up.
Secondary outcomes (4)
Prevalence of albuminuria assessed by urine albumin-to-creatinine ratio (ACR)
Albuminuria will be evaluated using the urine albumin-to-creatinine ratio (ACR) measured in spot urine samples. Abnormal ACR values will be used to identify early renal dysfunction in participants.
Measured: Baseline and up to 6 months of follow-up.
Prevalence of abnormal renal biochemical parameters
Assessment of abnormal renal laboratory parameters including serum creatinine and urea levels in participants with and without Inflammatory Bowel Disease.
Measured: Baseline and up to 6 months of follow-up.
Association between renal dysfunction and inflammatory bowel disease activity
Evaluation of the relationship between renal dysfunction and disease activity in patients with IBD assessed using the Total Mayo Score for Ulcerative Colitis and the Crohn's Disease Activity Index (CDAI) for Crohn Disease.
Measured: Baseline and up to 6 months of follow-up.
Association between renal dysfunction and medications used in inflammatory bowel disease
Assessment of the association between renal abnormalities and medications used for IBD treatment, including 5-aminosalicylates, immunosuppressants, and biologic therapies.
Measured: Baseline and up to 6 months of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start20 Nov 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for IBD and Renal InvolementStudies of the same condition, open and under way.
- 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
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji
- Sponsor type
- Other government
- Collaborators
- Poznan University of Medical Sciences, Nicolaus Copernicus university Collegium Medicum, Bydgoszcz, Poland, Medical University of Lodz, Jagiellonian University, Medical University of Silesia
- Responsible party
- Sponsor
- Investigators
- Grażyna Rydzewska, Professor, Study director, National Medical Institute of the Ministry of the Interior and Administration, Clinic of Gastroenterology and Internal Diseases.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07593352
- Sponsor's protocol ID
- 43/BW/2025
- Other IDs
- 43/BW/2025
- Acronym
- NEPHRO-IBD
- Status last verified
- May 2026
- First submitted
- 24 Mar 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified individual participant data may be available upon reasonable request from the principal investigator.
Publications
Wang H, Shi L, Qin J, Yousefi S, Li Y, Wang RK. Multimodal optical imaging can reveal changes in microcirculation and tissue oxygenation during skin wound healing. Lasers Surg Med. 2014 Aug;46(6):470-8. doi: 10.1002/lsm.22254. Epub 2014 May 1.
PubMed 24788236Lapane KL, Jakiche AF, Sugano D, Weng CS, Carey WD. Hepatitis C infection risk analysis: who should be screened? Comparison of multiple screening strategies based on the National Hepatitis Surveillance Program. Am J Gastroenterol. 1998 Apr;93(4):591-6. doi: 10.1111/j.1572-0241.1998.170_b.x.
PubMed 9576453Liu M, Zhang Y, Ye Z, Yang S, Zhou C, He P, Zhang Y, Hou FF, Qin X. Inflammatory Bowel Disease With Chronic Kidney Disease and Acute Kidney Injury. Am J Prev Med. 2023 Dec;65(6):1103-1112. doi: 10.1016/j.amepre.2023.08.008. Epub 2023 Aug 10.
PubMed 37572855Gordon H, Burisch J, Ellul P, Karmiris K, Katsanos K, Allocca M, Bamias G, Barreiro-de Acosta M, Braithwaite T, Greuter T, Harwood C, Juillerat P, Lobaton T, Muller-Ladner U, Noor N, Pellino G, Savarino E, Schramm C, Soriano A, Michael Stein J, Uzzan M, van Rheenen PF, Vavricka SR, Vecchi M, Zuily S, Kucharzik T. ECCO Guidelines on Extraintestinal Manifestations in Inflammatory Bowel Disease. J Crohns Colitis. 2024 Jan 27;18(1):1-37. doi: 10.1093/ecco-jcc/jjad108. No abstract available.
PubMed 37351850
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Observational Study Comparing the Prevalence of Renal Dysfunction in Adult Patient With Inflammatory Bowel Disease Between General Population: The NEPHRO-IBD Study.
- ClinicalTrials.gov ID
- NCT07593352
- Acronym / sponsor ID
- NEPHRO-IBD / 43/BW/2025
- Conditions
- IBD and Renal Involement, Chronic Kidney Disease, Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis)
- Keywords
- IBD, Crohn's Disease, Ulcerative Colitis, Renal Dysfunction, Chronic Kidney Disease, Extraintestinal Manifestations, Renal Complications in IBD, Albumin-to-Creatinine Ratio
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i AdministracjiOther government
- Collaborators
- Poznan University of Medical Sciences, Nicolaus Copernicus university Collegium Medicum, Bydgoszcz, Poland, Medical University of Lodz, Jagiellonian University, Medical University of Silesia
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 18 May 2026 (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 NEPHRO-IBD study is a multicenter prospective observational study designed to evaluate the prevalence of renal dysfunction and renal complications in adult patients with inflammatory bowel disease (IBD) compared with individuals from the general population. Although extraintestinal manifestations are common in IBD, renal involvement remains relatively underrecognized and insufficiently studied.
The study will recruit approximately 6,000 participants, including 3,000 patients with confirmed IBD (Crohn's disease or ulcerative colitis) and 3,000 individuals without IBD serving as a control group. Participants will undergo routine clinical assessment, including laboratory tests, urinalysis with measurement of the albumin-to-creatinine ratio (ACR), and imaging evaluation of the kidneys and urinary tract. Disease activity in patients with IBD will be assessed using validated clinical indices.
The study will also evaluate the relationship between renal dysfunction and disease activity, medications used in IBD treatment, and comorbidities. The results of this study are expected to improve the understanding of renal complications in patients with IBD and support earlier identification and management of kidney disease in this population.
Detailed description
Inflammatory bowel diseases (IBD), including Crohn's disease and ulcerative colitis, are chronic inflammatory disorders of the gastrointestinal tract that are frequently associated with extraintestinal manifestations. These manifestations may involve multiple organ systems, including the musculoskeletal, dermatologic, hepatobiliary, ocular, and renal systems. While several extraintestinal manifestations of IBD have been well described, renal complications remain relatively underrecognized and insufficiently investigated.
Renal manifestations associated with IBD may include nephrolithiasis, amyloidosis, tubulointerstitial nephritis, glomerulonephritis, urinary tract fistulas, and urothelial malignancies. In addition to disease-related mechanisms, potential contributing factors include immune dysregulation, genetic susceptibility, environmental factors, and nephrotoxic effects of medications used in the treatment of IBD, such as 5-aminosalicylates or thiopurines.
Previous studies suggest that patients with IBD may have an increased risk of chronic kidney disease (CKD) and acute kidney injury (AKI). However, the true prevalence and determinants of renal dysfunction in patients with IBD remain unclear due to limited prospective data.
The NEPHRO-IBD study is a multicenter prospective observational study designed to evaluate the prevalence of renal dysfunction and renal complications in adult patients with inflammatory bowel disease compared with individuals from the general population. Approximately 6,000 participants will be included, including 3,000 patients with confirmed IBD and 3,000 individuals without IBD serving as a control group.
Participants will undergo clinical assessment and routine laboratory testing at baseline and during follow-up visits performed at intervals of approximately three months. The evaluation will include blood tests, urinalysis with measurement of the urine albumin-to-creatinine ratio (ACR), and imaging assessment of the kidneys and urinary tract using abdominal ultrasound. In patients with IBD, disease activity will be evaluated using validated clinical indices, including the Total Mayo Score for ulcerative colitis and the Crohn's Disease Activity Index (CDAI). Fecal calprotectin levels will also be measured to assess intestinal inflammation.
The study will also investigate potential associations between renal abnormalities and inflammatory bowel disease activity, pharmacological treatment, and comorbid conditions. Early identification of renal dysfunction may facilitate timely nephrological evaluation and implementation of nephroprotective therapy in affected patients.
The results of the NEPHRO-IBD study are expected to improve understanding of renal involvement in inflammatory bowel disease and support the development of strategies for early detection and management of kidney disease in this population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group: IBD patients | – | Diagnostic Test: Prospective assessment of the prevalence of kidney disease and/or renal complications in patients with IBD/the general population based on routine laboratory test and abdominal ultrasound.Routine blood and urine tests performed every 3 and 6 months: peripheral blood count, CRP, glucose, total cholesterol, LDL, HDL, TGL, sodium, potassium, magnesium, phosphorus, uric acid, vitamin D3, albumin, urea, creatinine, calprotectin, and urinalysis with creatinine/albumin ratio (ACR) assessment. Assessment of the urinary system in abdominal ultrasound. |
| Control group - patients without IBD | – | Diagnostic Test: Prospective assessment of the prevalence of kidney disease and/or renal complications in patients with IBD/the general population based on routine laboratory test and abdominal ultrasound.Routine blood and urine tests performed every 3 and 6 months: peripheral blood count, CRP, glucose, total cholesterol, LDL, HDL, TGL, sodium, potassium, magnesium, phosphorus, uric acid, vitamin D3, albumin, urea, creatinine, calprotectin, and urinalysis with creatinine/albumin ratio (ACR) assessment. Assessment of the urinary system in abdominal ultrasound. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult participants recruited at multiple gastroenterology centers in Poland. The study will include approximately 6,000 individuals, including 3,000 patients with confirmed Inflammatory Bowel Disease (Crohn's disease or ulcerative colitis) and 3,000 individuals without IBD serving as a control group from the general population. Patients with IBD will be identified based on clinical evaluation and endoscopic confirmation of disease. Control participants will include adults without a diagnosis of inflammatory bowel disease who meet the study eligibility criteria. All participants will undergo clinical assessment, laboratory testing including blood tests and urinalysis with measurement of the albumin-to-creatinine ratio (ACR), and abdominal ultrasound evaluation of the kidneys and urinary tract. In patients with IBD, disease activity will additionally be assessed using validated clinical indices.
Key inclusion criteria (4 listed)
- Age over 18 years
- Confirmed IBD based on the overall clinical picture and endoscopic examination, or no IBD (control group without IBD)
- Consent to participate in the study
- Cognitive abilities sufficient to complete the questionnaires
Key exclusion criteria (27 listed)
- diabetes
- dysuric symptoms suggestive of urinary tract infections
- in women, menstruation (urinalysis can be performed 3 days before the onset and 3 days after the end of menstruation)
- refusal to participate in all procedures performed in the study
- age under 18 or over 80
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prospective assessment of the prevalence of kidney disease and/or renal complications in patients with IBD/the general population based on routine laboratory test and abdominal ultrasound.No experimental intervention is performed. Participants undergo routine clinical evaluation, laboratory testing, urinalysis including albumin-to-creatinine ratio (ACR), and abdominal ultrasound as part of observational data collection. | Diagnostic test | Control group - patients without IBD, Study group: IBD patients |
Primary outcome
Prevalence of renal dysfunction in patients with inflammatory bowel disease compared with the general population.
Time frame: Baseline and up to 6 months of follow-up.
Evaluation of the association between the occurrence of kidney disease and IBD activity (including measurement of fecal calprotectin levels), as well as medications used and comorbidities.
4 secondary outcomes
Prevalence of albuminuria assessed by urine albumin-to-creatinine ratio (ACR)
Time frame: Baseline and up to 6 months of follow-up.
Prevalence of abnormal renal biochemical parameters
Time frame: Baseline and up to 6 months of follow-up.
Association between renal dysfunction and inflammatory bowel disease activity
Time frame: Baseline and up to 6 months of follow-up.
Association between renal dysfunction and medications used in inflammatory bowel disease
Time frame: Baseline and up to 6 months of follow-up.
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 18 May 2026.
- Background: PubMed 24788236Wang H, Shi L, Qin J, Yousefi S, Li Y, Wang RK. Multimodal optical imaging can reveal changes in microcirculation and tissue oxygenation during skin wound healing. Lasers Surg Med. 2014 Aug;46(6):470-8. doi: 10.1002/lsm.22254. Epub 2014 May 1.
- Background: PubMed 9576453Lapane KL, Jakiche AF, Sugano D, Weng CS, Carey WD. Hepatitis C infection risk analysis: who should be screened? Comparison of multiple screening strategies based on the National Hepatitis Surveillance Program. Am J Gastroenterol. 1998 Apr;93(4):591-6. doi: 10.1111/j.1572-0241.1998.170_b.x.
- Background: PubMed 37572855Liu M, Zhang Y, Ye Z, Yang S, Zhou C, He P, Zhang Y, Hou FF, Qin X. Inflammatory Bowel Disease With Chronic Kidney Disease and Acute Kidney Injury. Am J Prev Med. 2023 Dec;65(6):1103-1112. doi: 10.1016/j.amepre.2023.08.008. Epub 2023 Aug 10.
- Background: PubMed 37351850Gordon H, Burisch J, Ellul P, Karmiris K, Katsanos K, Allocca M, Bamias G, Barreiro-de Acosta M, Braithwaite T, Greuter T, Harwood C, Juillerat P, Lobaton T, Muller-Ladner U, Noor N, Pellino G, Savarino E, Schramm C, Soriano A, Michael Stein J, Uzzan M, van Rheenen PF, Vavricka SR, Vecchi M, Zuily S, Kucharzik T. ECCO Guidelines on Extraintestinal Manifestations in Inflammatory Bowel Disease. J Crohns Colitis. 2024 Jan 27;18(1):1-37. doi: 10.1093/ecco-jcc/jjad108. No abstract available.
- Individual participant dataSharing planned: Undecided. De-identified individual participant data may be available upon reasonable request from the principal investigator.
Related trials for IBD and Renal Involement
Not yet recruitingObservational study
Renal Involvement in Adult Patients With Inflammatory Bowel Disease and Its Relation to Duration and Disease Activity
IBD and Renal Involement, IBD Activity and Kidney Affection
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.
Konrad Lewandowski, Associate/Assistant Professor contact
Grażyna Rydzewska, Professor study director
National Medical Institute of the Ministry of the Interior and Administration, Clinic of Gastroenterology and Internal Diseases.
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 and Renal Involement and Chronic Kidney Disease, run by Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji at 1 site in Poland.
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 4 inclusion and 27 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: looking for participants now, as of the sponsor's last update on 18 May 2026. 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 Poland. 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?
Contact Krzysztof Jaroń, MD, MPharm (+48 477 22 12 40, krzysztof.jaron@pimmswia.gov.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of renal dysfunction in patients with inflammatory bowel disease compared with the general population. (time frame: Baseline and up to 6 months of follow-up.). 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 NCT07593352, which also lists 4 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 18 May 2026.