Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Renal Manifestations of IBD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04301297
Recruitment Status : Not yet recruiting
First Posted : March 10, 2020
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Faiza Kamal Abd Elkhalek, Assiut University

Brief 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.

Condition or disease
Kidney Diseases

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 194 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Renal Manifestations of IBD
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : May 2021



Primary Outcome Measures :
  1. Renal manifestations of IBD [ Time Frame: 12 month ]
    Access renal manifestations of IBD



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
All patients with IBD without any of exclusion criteria will be enrolled in the study
Criteria

Inclusion Criteria:

- A ny patients with IBD

Exclusion Criteria:

Pregnant kidney disease

Publications:
Layout table for additonal information
Responsible Party: Faiza Kamal Abd Elkhalek, AssiutU, Assiut University
ClinicalTrials.gov Identifier: NCT04301297    
Other Study ID Numbers: Renal manifestations of IBD
First Posted: March 10, 2020    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Urologic Diseases