- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06601829
Congenital Hepatic Fibrosis and Autosomal Recessive Polycystic Kidney Disease in Children at Sohag University Hospital
September 16, 2024 updated by: Sherein Awad Mohamed, Sohag University
polycystic kidney disease is aherditary disorder characterized by the formation of numerous fluid filled cysts in the kidneys which can lead to progressive renal impairment PKDencompasses aspectrum of disorders with autosomal dominant polycystic kidneydisease and autosomal recessive polycystic kidney disease being the two main types
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Sohag, Egypt
- Recruiting
- Sohag University Hospital
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Contact:
- Magdy M Amin, Professor
- Phone Number: 0934602963
- Email: Portal@med.sohag.edu.eg
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
cross sectional study prospective and retrospective
Description
Inclusion Criteria:
- pediatric patients aged 0-18 years both male and female patients
Exclusion Criteria:
- patients whose guardians dont provide informed consent patients who are not complient with follow up vists and data collection protocols
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
incidence of congenital hepatic fibrosis in patient with autosomal recessive polycyctic kidney disease
Time Frame: 12 months
|
describe congenital hepatic fibrosis in patient with autosomal recessive polycystic kidney explaining their clinical manifestations.diagnosis.managment and complications
|
12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Webster AC, Nagler EV, Morton RL, Masson P. Chronic Kidney Disease. Lancet. 2017 Mar 25;389(10075):1238-1252. doi: 10.1016/S0140-6736(16)32064-5. Epub 2016 Nov 23.
- Paul BM, Vanden Heuvel GB. Kidney: polycystic kidney disease. Wiley Interdiscip Rev Dev Biol. 2014 Nov-Dec;3(6):465-87. doi: 10.1002/wdev.152. Epub 2014 Sep 3.
- Salman MA, Elgebaly A, Soliman NA. Epidemiology and outcomes of pediatric autosomal recessive polycystic kidney disease in the Middle East and North Africa. Pediatr Nephrol. 2024 Sep;39(9):2569-2578. doi: 10.1007/s00467-024-06281-0. Epub 2024 Jan 23.
- Khare A, Krishnappa V, Kumar D, Raina R. Neonatal renal cystic diseases. J Matern Fetal Neonatal Med. 2018 Nov;31(21):2923-2929. doi: 10.1080/14767058.2017.1358263. Epub 2017 Aug 2.
- Lucchetti L, Chinali M, Emma F, Massella L. Autosomal dominant and autosomal recessive polycystic kidney disease: hypertension and secondary cardiovascular effect in children. Front Mol Biosci. 2023 Mar 10;10:1112727. doi: 10.3389/fmolb.2023.1112727. eCollection 2023.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2024
Primary Completion (Estimated)
August 1, 2025
Study Completion (Estimated)
August 1, 2025
Study Registration Dates
First Submitted
September 16, 2024
First Submitted That Met QC Criteria
September 16, 2024
First Posted (Estimated)
September 19, 2024
Study Record Updates
Last Update Posted (Estimated)
September 19, 2024
Last Update Submitted That Met QC Criteria
September 16, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Urologic Diseases
- Congenital Abnormalities
- Liver Diseases
- Abnormalities, Multiple
- Kidney Diseases, Cystic
- Ciliopathies
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Fibrosis
- Kidney Diseases
- Liver Cirrhosis
- Polycystic Kidney Diseases
- Genetic Diseases, Inborn
- Polycystic Kidney, Autosomal Recessive
Other Study ID Numbers
- soh-Med-24-08-01MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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