Sickle Cell NephropathyNCT03680547
Nephropathy in Patients With Sickle Cell Disease
An observational study of Sickle Cell Nephropathy, run by Assiut University.
Trial summary
There are some diseases that give rise to diverse renal manifestations as does sickle cell disease Read more about this study
- Who is it for?
- Ages 5 months to 18 years
- Conditions the study is for
- Sickle Cell Nephropathy
- What is being tested?
- patient with sickle cell disease
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2020to 1 Jan 2021
- 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 5 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: to assess degree of renal affection in patients with sickle cell disease attending Assuit university Children hospital by estimating some predictors of glomerular and tubular dysfunction.detailed history taking and thorough clinical examination and laboratory investigations
Who may be able to join
- All patients with sickle cell anemia attending the unit will be included in the study.
Who cannot join
- patient with any underlaying systemic diseases other than sickle cell anaemia
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pattern of Sickle Cell Nephropathy in Patients With Sickle Cell Disease
There are some diseases that give rise to diverse renal manifestations as does sickle cell disease
Read the detailed description
Such involvement adversely affects virtually all major physiological processes in the kidney, and leads to complications that are common and chronic on the one hand (such as impaired urinary concentrating ability), and those that are rare and uniformly fatal on the other (such as renal medullary carcinoma) This steady adverse renal sequelae shortens the average lifespan of patients with SCD.
Proteinuria and a reduced glomerular filtration rate are risk factors associated with increased mortality among those patients with approximately 16-18% of overall mortality in this patient group is due to kidney disease.
Once end stage renal disease is reached, the mortality of patients who are on haemodialysis and have SCD is increased severalfold relative to the mortality of patients who are on haemodialysis but do not have SCD.
Thus,although the average lifespan of patients with SCD has increased during recent decades owing to improved management of complications outside the kidney,kidney disease contributes substantially to the still increased mortality in SCD.
- Conditions
- Sickle Cell Nephropathy
- Being tested
- patient with sickle cell disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient with sickle cell diseaseOther
assess degree of renal affection in patientswith sickle cell disease attending Assuit university Children hospital by estimating some predictors of glomerular and tubular dysfunction.
What is being measured
The primary outcome is the main question the study is designed to answer.
sickle cell nephropathy in patient with sickle cell disease
detection of renal impairment in patients with sickle cell disease by estamating gloerular and tubular dysfunction clinicaly and laboratory
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start1 May 2020 (estimated)
- Primary completion30 May 2020 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell NephropathyStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, omnia talat hasan, Assiut University
- Investigators
- omnia talat hasan, Principal investigator, assiut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680547
- Sponsor's protocol ID
- npscd
- Status last verified
- Nov 2019
- First submitted
- 20 Sep 2018
- Last updated
- 29 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern of Sickle Cell Nephropathy in Patients With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT03680547
- Acronym / sponsor ID
- npscd
- Conditions
- Sickle Cell Nephropathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 30 May 2020 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 21 Sep 2018 (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.
There are some diseases that give rise to diverse renal manifestations as does sickle cell disease
Detailed description
Such involvement adversely affects virtually all major physiological processes in the kidney, and leads to complications that are common and chronic on the one hand (such as impaired urinary concentrating ability), and those that are rare and uniformly fatal on the other (such as renal medullary carcinoma) This steady adverse renal sequelae shortens the average lifespan of patients with SCD.
Proteinuria and a reduced glomerular filtration rate are risk factors associated with increased mortality among those patients with approximately 16-18% of overall mortality in this patient group is due to kidney disease.
Once end stage renal disease is reached, the mortality of patients who are on haemodialysis and have SCD is increased severalfold relative to the mortality of patients who are on haemodialysis but do not have SCD.
Thus,although the average lifespan of patients with SCD has increased during recent decades owing to improved management of complications outside the kidney,kidney disease contributes substantially to the still increased mortality in SCD.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 5 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- to assess degree of renal affection in patients with sickle cell disease attending Assuit university Children hospital by estimating some predictors of glomerular and tubular dysfunction.detailed history taking and thorough clinical examination and laboratory investigations
Key inclusion criteria (1 listed)
- All patients with sickle cell anemia attending the unit will be included in the study.
Key exclusion criteria (1 listed)
- patient with any underlaying systemic diseases other than sickle cell anaemia
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 |
|---|---|---|
| patient with sickle cell diseaseassess degree of renal affection in patientswith sickle cell disease attending Assuit university Children hospital by estimating some predictors of glomerular and tubular dysfunction. | Other | – |
Primary outcome
sickle cell nephropathy in patient with sickle cell disease
Time frame: one year
detection of renal impairment in patients with sickle cell disease by estamating gloerular and tubular dysfunction clinicaly and laboratory
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
- Individual participant dataSharing planned: 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.
omnia talat hasan principal investigator
assiut
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Nephropathy, run by Assiut University.
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 29 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact fahim mohamed fahim (01002500073, fahim.osman@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sickle cell nephropathy in patient with sickle cell disease (time frame: one year). 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 29 Nov 2019.