Congenital Hepatic Fibrosis and Autosomal Recessive Polycystic Kidney Disease in Children at Sohag University HospitalNCT06601829
Congenital Hepatic Fibrosis and Autosomal Recessive Polycystic Kidney Disease in Children at Sohag University Hospital
An observational study of Congenital Hepatic Fibrosis and Autosomal Recessive Polycystic Kidney Disease in Children at Sohag University Hospital, run by Sohag University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Hepatic Fibrosis and Autosomal Recessive Polycystic Kidney Disease in Children at Sohag University Hospital
- What is being tested?
- abdominal ultrasound
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to 1 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: cross sectional study prospective and retrospective
Who may be able to join
- pediatric patients aged 0-18 years both male and female patients
Who cannot join
- patients whose guardians dont provide informed consent patients who are not complient with follow up vists and data collection protocols
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag university Hospital
Sohag
Magdy m amin, professor, 0934602963, portal@med.sohag.edu.eg
About this study
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
- Being tested
- abdominal ultrasound
- Medical subject headings
- Hepatic Fibrosis, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abdominal ultrasoundOther
abdominal ulterasound showing multiple cysts in the kidnets and hepatic fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of congenital hepatic fibrosis in patient with autosomal recessive polycyctic kidney disease
describe congenital hepatic fibrosis in patient with autosomal recessive polycystic kidney explaining their clinical manifestations.diagnosis.managment and complications
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Aug 2024
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Congenital Hepatic Fibrosis and Autosomal Recessive Polycystic Kidney Disease in Children at Sohag University HospitalStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherein Awad Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06601829
- Sponsor's protocol ID
- soh-Med-24-08-01MS
- Status last verified
- Sep 2024
- First submitted
- 16 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25186187Salman 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.
PubMed 38261064Khare 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.
PubMed 28764564Webster 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.
PubMed 27887750Lucchetti 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.
PubMed 37006611
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Congenital Hepatic Fibrosis and Autosomal Recessive Polycystic Kidney Disease in Children at Sohag University Hospital
- ClinicalTrials.gov ID
- NCT06601829
- Acronym / sponsor ID
- soh-Med-24-08-01MS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- cross sectional study prospective and retrospective
Key inclusion criteria (1 listed)
- pediatric patients aged 0-18 years both male and female patients
Key exclusion criteria (1 listed)
- patients whose guardians dont provide informed consent patients who are not complient with follow up vists and data collection protocols
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| abdominal ultrasoundabdominal ulterasound showing multiple cysts in the kidnets and hepatic fibrosis | Other | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 25186187Paul 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.
- Background: PubMed 38261064Salman 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.
- Background: PubMed 28764564Khare 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.
- Background: PubMed 27887750Webster 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.
- Background: PubMed 37006611Lucchetti 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Hepatic Fibrosis and Autosomal Recessive Polycystic Kidney Disease in Children at Sohag University Hospital, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of congenital hepatic fibrosis in patient with autosomal recessive polycyctic kidney disease (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06601829, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024; AzTrials last refreshed its copy on 8 Nov 2026.