Renal Tubular Disorders in ChildrenNCT04845815
Renal Tubular Disorders in Egyptian Children
An observational study of Renal Tubular Disorders in Children, run by Sohag University at 1 site in Egypt.
Trial summary
Renal tubules play an important role in fluid, electrolyte, and acid-base homeostasis. Defect of these functions can give rise to a host of disorders. These disorders can lead to life threatening disturbances in electrolytes and acid-base balance. In Egypt, there is little data about these disorders. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Renal Tubular Disorders in Children
- How many people
- 58 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Apr 2021to 7 Jan 2022
- How long will I take part?
- 1 Year
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: all children who have renal tubular disorders (inpatient and outpatient) in the Paediatric Department, Sohage University Hospital.
Who may be able to join
- All children aged from one month to 18 years who have renal tubular disorders.
Who cannot join
- Children who have renal tubular disorders secondary to drugs, intoxication, obstructive uropathy or transient in nature.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patterns of Renal Tubular Disorders in Egyptian Children: a Single Center Study
Renal tubules play an important role in fluid, electrolyte, and acid-base homeostasis. Defect of these functions can give rise to a host of disorders. These disorders can lead to life threatening disturbances in electrolytes and acid-base balance. In Egypt, there is little data about these disorders. Many of these cases are diagnosed late, therefore Early suspicion for diagnosis can improve the overall clinical outcome of these children.
Read the detailed description
Renal tubules play an important role in fluid, electrolyte, and acid-base homeostasis. Defect of these functions can give rise to a host of disorders. These disorders can lead to life threatening disturbances in electrolytes and acid-base balance. In Egypt, there is little data about these disorders. Many of these cases are diagnosed late, therefore Early suspicion for diagnosis can improve the overall clinical outcome of these children. As a result, starting management early will help those children have a better life. Therefore awareness about these disorders and long-term outcome is really important. The investigators present the clinical characterizations of many tubular disorder and the follow up in our center.
The aim of this study is to reveal the different clinical presentations and the main lab features of renal tubular disorders in children to promote early recognition and management.
- Conditions
- Renal Tubular Disorders in Children
- Keywords
- renal tubular disorders, failure to thrive, metabolic acidosis, metabolic alkalosis, hypokalemia
- Medical subject headings
- Failure to Thrive, Acidosis, Hypokalemia
What is being measured
The primary outcome is the main question the study is designed to answer.
weight
in kilograms
Measured: 1 years
Glomerular function
The glomerular function was assessed by estimated glomerular filtration rate (eGFR) calculated using Schwartz formula. Chronic kidney disease (CKD) was defined in the presence of a permanent reduction in GFR (e-GFR; <60 ml/min/1.73 m2 Kidney Disease Outcomes Quality Initiative < stage 3).
Measured: 1 years
height
in meters
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start23 Apr 2021
- Primary completion9 Dec 2021
- Study completion7 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Tubular Disorders in ChildrenStudies 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 only
- Time perspective
- Other
- Enrolment
- 58 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ashraf Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845815
- Sponsor's protocol ID
- Soh-Med-21-04-04
- Status last verified
- Apr 2021
- First submitted
- 12 Apr 2021
- Last updated
- 7 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patterns of Renal Tubular Disorders in Egyptian Children: a Single Center Study
- ClinicalTrials.gov ID
- NCT04845815
- Acronym / sponsor ID
- Soh-Med-21-04-04
- Conditions
- Renal Tubular Disorders in Children
- Keywords
- renal tubular disorders, failure to thrive, metabolic acidosis, metabolic alkalosis, hypokalemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 23 Apr 2021 (actual)
- Primary completion
- 9 Dec 2021 (actual)
- Study completion
- 7 Jan 2022 (actual)
- First posted
- 15 Apr 2021 (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.
Renal tubules play an important role in fluid, electrolyte, and acid-base homeostasis. Defect of these functions can give rise to a host of disorders. These disorders can lead to life threatening disturbances in electrolytes and acid-base balance. In Egypt, there is little data about these disorders. Many of these cases are diagnosed late, therefore Early suspicion for diagnosis can improve the overall clinical outcome of these children.
Detailed description
Renal tubules play an important role in fluid, electrolyte, and acid-base homeostasis. Defect of these functions can give rise to a host of disorders. These disorders can lead to life threatening disturbances in electrolytes and acid-base balance. In Egypt, there is little data about these disorders. Many of these cases are diagnosed late, therefore Early suspicion for diagnosis can improve the overall clinical outcome of these children. As a result, starting management early will help those children have a better life. Therefore awareness about these disorders and long-term outcome is really important. The investigators present the clinical characterizations of many tubular disorder and the follow up in our center.
The aim of this study is to reveal the different clinical presentations and the main lab features of renal tubular disorders in children to promote early recognition and management.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- all children who have renal tubular disorders (inpatient and outpatient) in the Paediatric Department, Sohage University Hospital.
Key inclusion criteria (1 listed)
- All children aged from one month to 18 years who have renal tubular disorders.
Key exclusion criteria (1 listed)
- Children who have renal tubular disorders secondary to drugs, intoxication, obstructive uropathy or transient in nature.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
weight
Time frame: 1 years
in kilograms
Glomerular function
Time frame: 1 years
The glomerular function was assessed by estimated glomerular filtration rate (eGFR) calculated using Schwartz formula. Chronic kidney disease (CKD) was defined in the presence of a permanent reduction in GFR (e-GFR; <60 ml/min/1.73 m2 Kidney Disease Outcomes Quality Initiative < stage 3).
height
Time frame: 1 years
in meters
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- Individual participant dataSharing planned: Undecided. undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Renal Tubular Disorders in Children, 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: finished, as of the sponsor's last update on 7 Feb 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight (time frame: 1 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Feb 2022.