CClinicalTrials.gg
Status unknownNCT04301297Updated Jan 28, 2021

Renal Manifestations of IBD

An observational study in Kidney Diseases, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-01-28.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Jan 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
194
Ages
18 Years to 70 Years
Sex
All
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Study summary

To detect whether patients with inflammarory bowel disease (IBD) have some degree of renal involvement and also to determine if associated with disease activity or not.

Read the detailed description

Inflammatory bowel diseases (IBD) comprise two types of chronic intestinal disorders: Crohn's disease (CD) and ulcerative colitis (UC). CD involves the ileum and colon, but it can affect any region of the intestine, often discontinuously. UC involves the rectum and may affect part of the colon or the entire colon (pancolitis) in an un interrupted pattern. In Crohn's, the inflammation is often transmural, whereas in Ulcerative colitis the inflammation is typically confined to the mucosa . The extraintestinal manifestations of IBD are common and may occur in 25%-40% of patients. Inflammatory manifestations in the skin, eyes, liver and joints are considered primary manifestations. Development of primary extra intestinal manifestation appears to increase the risk of developing a second extra intestinal manifestation. Most IBD patients with extra intestinal manifestations have colonic inflammation, although some patients develop them prior to the onset of colonic symptoms. Extra intestinal manifestations are usually present at the time of active phase of IBD . In recent years, there have been reports on renal and urologic complications of IBD. They were mostly found to be related to ureteral obstruction by oxalate stones, cystitis, acute tubular necrosis due to volume depletion and AA amyloidosis. Nephrolithiasis and obstructive uropathy are especially seen with small bowel dysfunction. In a great proportion of IBD patients, ureteral obstruction is not caused by stones. This non calculus obstruction can occur in 50%-73% of CD patients and 50% of UC patients, and is usually caused by retroperitoneal local inflammation or by surgical complication (sutures) or colon cancer . There have also been reports of interstitial nephritis, mainly due to applied anti-inflammatory therapy, such as 5-aminosalicylic acid (5-ASA). Serious renal impairment is reported to occur in 1 of 500 patients treated with 5-ASA derivative. On the other hand, there are some reports that renal tubular damage is an extra intestinal manifestation of IBD and not a toxic side effect of anti-inflammatory therapy using 5-ASA or sulfasalazine. Furthermore, renal failure due to glomerulonephritis (GN) caused by the immune complex has been reported in several cases as an extraintestinal manifestation of IBD.

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Conditions studied

  • Kidney Diseases

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In context

Kidney Diseases

3,838 studies on the registry are indexed under Kidney Diseases; 498 are open to participants now.

This study's planned enrollment of 194 is close to the median of 192 across 1,032 observational studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Assiut University is the lead sponsor of 4,916 studies on the registry; 2,113 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

All patients with IBD without any of exclusion criteria will be enrolled in the study

Inclusion criteria

  • A ny patients with IBD

Exclusion criteria

Exclusion Criteria:

Pregnant kidney disease

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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
194 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Renal manifestations of IBD

    Access renal manifestations of IBD

    Time frame: 12 month

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Study locations

1 of 1 sites recruiting
  • Egypt
    Assiut, 11117, Egypt
    • Fayza Kamel Abdelkalek, Resident · Contact · 01060564991
    Recruiting
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References and documents

Publications

  • Ambruzs JM, Larsen CP. Renal Manifestations of Inflammatory Bowel Disease. Rheum Dis Clin North Am. 2018 Nov;44(4):699-714. doi: 10.1016/j.rdc.2018.06.007. Epub 2018 Sep 7. PubMed 30274631 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04301297
Lead sponsor
Assiut University
Responsible party
Faiza Kamal Abd Elkhalek (AssiutU, Assiut University) — Principal investigator
First posted
Mar 10, 2020
Start date
Feb 1, 2020
Primary completion
Apr 2021 (estimated)
Completion
May 2021 (estimated)
Last update
Jan 28, 2021

Study contacts

Fayez Kamal Abdelkhalek, Resident
Contact
fkamal263@gmail.com
01060564991 ext. 002

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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