NCT04282577

Brief Summary

The study aims to early detection of renal injury in patients diagnosed to have inflammatory bowel disease with normal kidney function test focusing on glomerular filtration barrier injury and tubular injury and it's relation to disease activity so precautions could be taken properly to prevent further renal injury later on .

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 Mar 2020

Status
unknown

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

February 21, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 25, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

1.7 years

First QC Date

February 21, 2020

Last Update Submit

February 24, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Early detection of renal injury in patients diagnosed to have inflammatory bowel disease with normal kidney function

    using urinary biomarkers (nephrin and alpha one microglobulin ) for early detection of renal injury in inflammatory bowel disease patients

    baseline

Study Arms (2)

patients with chron's disease

Diagnostic Test: urinary nephrin and alpha one microglobulin

patients with ulcerative cholitis

Diagnostic Test: urinary nephrin and alpha one microglobulin

Interventions

urinary nephrin and alpha one microglobulin are biomarkers of glomerular filtration barrier injury and tubular injury respectively measured by ELISA

patients with chron's diseasepatients with ulcerative cholitis

Eligibility Criteria

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

inflammatory bowel disease patients aging more than 18 with no concomitent kidney disease

You may qualify if:

  • \- Patients diagnosed to have inflammatory bowel disease (ulcerative colitis or chron's disease )with age more than 18 years and normal kidney function test

You may not qualify if:

  • Patients known to have renal disease due to other causes . Diabetic patients . Hypertensive patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Akankwasa G, Jianhua L, Guixue C, Changjuan A, Xiaosong Q. Urine markers of podocyte dysfunction: a review of podocalyxin and nephrin in selected glomerular diseases. Biomark Med. 2018 Aug;12(8):927-935. doi: 10.2217/bmm-2018-0152. Epub 2018 Jul 6.

    PMID: 29976076BACKGROUND
  • Chang CJ, Wang PC, Huang TC, Taniguchi A. Change in Renal Glomerular Collagens and Glomerular Filtration Barrier-Related Proteins in a Dextran Sulfate Sodium-Induced Colitis Mouse Model. Int J Mol Sci. 2019 Mar 22;20(6):1458. doi: 10.3390/ijms20061458.

    PMID: 30909435BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

February 21, 2020

First Posted

February 25, 2020

Study Start

March 1, 2020

Primary Completion

November 1, 2021

Study Completion

December 1, 2021

Last Updated

February 25, 2020

Record last verified: 2020-02