NCT06717516

Brief Summary

To Assess the pattern of renal injury in patients with inflammatory bowel disease and its relation to the duration and disease activity by Identification and characterization of early renal manifestations (e.g., proteinuria, hematuria, electrolyte imbalances) in IBD patients. and know Correlation between kidney involvement and IBD severity, including flare-ups and complications. and know Impact of early renal manifestations on long-term renal outcomes, such as progression to CKD or development of AKI.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

December 5, 2024

Status Verified

November 1, 2024

Enrollment Period

1 year

First QC Date

November 30, 2024

Last Update Submit

November 30, 2024

Conditions

Keywords

IBD and kidney

Outcome Measures

Primary Outcomes (1)

  • Identification of renal manifestations in IBD patients and Correlation between kidney involvement and IBD severity, including flare-ups and complications and its Impact on long-term renal outcomes, such as progression to CKD or development of AKI

    Identification and characterization of renal manifestations (e.g., proteinuria, hematuria, electrolyte imbalances) in IBD patients and Correlation between kidney involvement and IBD severity, including flare-ups and complications and Impact of early renal manifestations on long-term renal outcomes, such as progression to CKD or development of AKI

    scheduled follow-ups at 3,6,12 months

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults aged 18 years or older with Confirmed diagnosis of IBD either crohns disease or ulcerative colities based on clinical ,endoscopic ,histological and radiological findings

You may qualify if:

  • Adults aged 18 years or older
  • Confirmed diagnosis of IBD either crohns disease or ulcerative colities based on clinical ,endoscopic ,histological and radiological findings . - Patients in any stage of IBD, including remission, active disease, and flare-ups. - Willingness to participate and provide informed consent. - Renal Assessment for participants.

You may not qualify if:

  • \- Pre-existing chronic kidney disease (CKD) at any stage. - Known primary kidney diseases unrelated to IBD. - Current use of nephrotoxic medications not related to IBD treatment. - Pregnancy or breastfeeding. - Patients who are unable to comply with study protocols or follow-up assessment - Presence of other significant comorbidities that impact renal function or overall health

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Lian X, Wang Y, Wang S, Peng X, Wang Y, Huang Y, Chen W. Does inflammatory bowel disease promote kidney diseases: a mendelian randomization study with populations of European ancestry. BMC Med Genomics. 2023 Sep 26;16(1):225. doi: 10.1186/s12920-023-01644-2.

    PMID: 37752523BACKGROUND
  • Evenepoel P, Poesen R, Meijers B. The gut-kidney axis. Pediatr Nephrol. 2017 Nov;32(11):2005-2014. doi: 10.1007/s00467-016-3527-x. Epub 2016 Nov 15.

    PMID: 27848096BACKGROUND
  • Kumar S, Pollok R, Goldsmith D. Renal and Urological Disorders Associated With Inflammatory Bowel Disease. Inflamm Bowel Dis. 2023 Aug 1;29(8):1306-1316. doi: 10.1093/ibd/izac140.

    PMID: 35942657BACKGROUND
  • Kellum JA, Romagnani P, Ashuntantang G, Ronco C, Zarbock A, Anders HJ. Acute kidney injury. Nat Rev Dis Primers. 2021 Jul 15;7(1):52. doi: 10.1038/s41572-021-00284-z.

    PMID: 34267223BACKGROUND
  • van Hoeve K, Hoffman I. Renal manifestations in inflammatory bowel disease: a systematic review. J Gastroenterol. 2022 Sep;57(9):619-629. doi: 10.1007/s00535-022-01903-6. Epub 2022 Jul 14.

    PMID: 35834005BACKGROUND
  • Piovani D, Danese S, Peyrin-Biroulet L, Bonovas S. Environmental, Nutritional, and Socioeconomic Determinants of IBD Incidence: A Global Ecological Study. J Crohns Colitis. 2020 Mar 13;14(3):323-331. doi: 10.1093/ecco-jcc/jjz150.

    PMID: 31504350BACKGROUND

Study Officials

  • Effat AbdelHady Tony Ahmed

    STUDY CHAIR
  • Mohammed Abdelhakim Elmahdy

    STUDY DIRECTOR

Central Study Contacts

Esraa Abdel-Aal Khalifa Abdel-Aal

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Renal Involvement in Adult patients with Inflammatory bowel disease and its relation to duration and disease activity .

Study Record Dates

First Submitted

November 30, 2024

First Posted

December 5, 2024

Study Start

December 1, 2024

Primary Completion

December 1, 2025

Study Completion

January 1, 2026

Last Updated

December 5, 2024

Record last verified: 2024-11