PSGN - Post-Streptococcal GlomerulonephritisNCT03184103
Acute Post Streptococcal Glomerulonephritis
An observational study of PSGN - Post-Streptococcal Glomerulonephritis, run by Assiut University.
Trial summary
Acute post streptococcal glomerulonephritis is an immunologic response of the kidney to infection, characterized by the sudden appearance of edema, hematuria, proteinuria and hypertension . It is essentially a disease of childhood that accounts for approximately 90% of renal disorders in children. Read more about this study
- Who is it for?
- Ages 2 to 15 years
- Conditions the study is for
- PSGN - Post-Streptococcal Glomerulonephritis
- What is being tested?
- anti streptolysin o titre and serum complement test
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 27 Jun 2017to 27 Dec 2019
- 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 2 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: This study will be done on children attending at Assiut University Children Hospital with clinical manifestation of acute post streptococcal glomerulonephritis during one year period . In addition to meticulous history taking and thorough clinical examination , all the cases will be subjected to the following laboratory investigations : Complete blood count on admission, urine analysis, blood urea, serum creatinine, serum albumin, serum cholesterol, urine spot protein creatinine ratio, antistreptolysin O , Erythrocyte sedimentation rate , C-reactive protein and serum complement C3 levels on admission and after 8 weeks.
Who may be able to join
- Children in the age groups of 2-15 years. presenting with clinical manifestation of acute nephritic syndrome will be included in the study.
Who cannot join
- Children having history suggestive of chronic renal and cardiac disease in the past
- Children with congenital renal anomalies .
- Children with clinical manifestation of nephrotic syndrome .
- Children with clinical manifestation of acute nephritic syndrome due to other causes .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Spectrum and Outcome of Acute Post Streptococcal Glomerulonephritis in Children .
Acute post streptococcal glomerulonephritis is an immunologic response of the kidney to infection, characterized by the sudden appearance of edema, hematuria, proteinuria and hypertension . It is essentially a disease of childhood that accounts for approximately 90% of renal disorders in children. The disease occurs especially in children between the ages of 2 and 12 years and young adults, and more often in male than in female .
Read the detailed description
Acute post streptococcal glomerulonephritis are caused by group A beta haemolytic streptococci and follow upper airway infections such as pharyngitis or tonsillitis, by 14 to 21 days and 3-6 weeks after skin infection especially in warmer climates .
In recent decades the number of patients with post streptococcal glomerulonephritis has decreased considerably in the United States and Europe industrialized countries. In other parts of the world ,some developing communities. the incidence of post streptococcal glomerulonephritis has remained high. post streptococcal glomerulonephritis is one of the leading cause requiring hospital admissions in children , and it is also an important cause of acute renal failure in developing countries. Though deaths due to this disease are rare, it can cause serious complications such as hypertensive emergency, congestive cardiac failure, renal failure, encephalopathy and retinopathy .
Acute post streptococcal glomerulonephritis can also progress to rapidly progressive glomerulonephritis which is defined as''a syndrome that progresses rapidly within a few weeks or months to renal failure and is accompanied by urinary findings of nephritis.'' The clinical concept of rapidly progressive glomerulonephritis includes various renal diseases that cause renal function to deteriorate over a subacute course. Necrotizing crescentic glomerulonephritis is often observed in histopathological findings .
Acute post streptococcal glomerulonephritis was diagnosed in the presence of :
features of acute nephritic syndrome. evidence of recent streptococcal infection. lower serum complement three levels. Anti streptolysin o titre >200 units/ml was considered as evidence of recent streptococcal infection
- Being tested
- anti streptolysin o titre and serum complement test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti streptolysin o titre and serum complement testDiagnostic test
diagnostic lab test
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with full recovery or having complication at time of discharge and after 8 week
serum complementary test by ELISA
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 posted12 Jun 2017
- Study start27 Jun 2017 (estimated)
- Primary completion27 Jun 2019 (estimated)
- Study completion27 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for PSGN - Post-Streptococcal GlomerulonephritisStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MSHEid, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03184103
- Sponsor's protocol ID
- APSGN
- Status last verified
- Jun 2017
- First submitted
- 8 Jun 2017
- Last updated
- 14 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Couser WG. Glomerulonephritis. Lancet. 1999 May 1;353(9163):1509-15. doi: 10.1016/S0140-6736(98)06195-9.
PubMed 10232333Arimura Y, Muso E, Fujimoto S, Hasegawa M, Kaname S, Usui J, Ihara T, Kobayashi M, Itabashi M, Kitagawa K, Hirahashi J, Kimura K, Matsuo S. Evidence-based clinical practice guidelines for rapidly progressive glomerulonephritis 2014. Clin Exp Nephrol. 2016 Jun;20(3):322-41. doi: 10.1007/s10157-015-1218-8. No abstract available.
PubMed 27099135Arora P, Kher V, Rai PK, Singhal MK, Gulati S, Gupta A. Prognosis of acute renal failure in children: a multivariate analysis. Pediatr Nephrol. 1997 Apr;11(2):153-5. doi: 10.1007/s004670050247.
PubMed 9090652Barbiano Di Belgiojoso G, Genderini A, Ferrario F. [Post-infectious glomerulonephritis]. G Ital Nefrol. 2003 Mar-Apr;20(2):184-99. Italian.
PubMed 12746805Matsukura H, Ohtsuki A, Fuchizawa T, Miyawaki T. Acute poststreptococcal glomerulonephritis mimicking Henoch-Schonlein purpura. Clin Nephrol. 2003 Jan;59(1):64-5. doi: 10.5414/cnp59064. No abstract available.
PubMed 12572934Mehta RL, Kellum JA, Shah SV, Molitoris BA, Ronco C, Warnock DG, Levin A; Acute Kidney Injury Network. Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury. Crit Care. 2007;11(2):R31. doi: 10.1186/cc5713.
PubMed 17331245Nordstrand A, Norgren M, Holm SE. Pathogenic mechanism of acute post-streptococcal glomerulonephritis. Scand J Infect Dis. 1999;31(6):523-37. doi: 10.1080/00365549950164382.
PubMed 10680980Kanjanabuch T, Kittikowit W, Eiam-Ong S. An update on acute postinfectious glomerulonephritis worldwide. Nat Rev Nephrol. 2009 May;5(5):259-69. doi: 10.1038/nrneph.2009.44.
PubMed 19384327
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Spectrum and Outcome of Acute Post Streptococcal Glomerulonephritis in Children .
- ClinicalTrials.gov ID
- NCT03184103
- Acronym / sponsor ID
- APSGN
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 27 Jun 2017 (estimated)
- Primary completion
- 27 Jun 2019 (estimated)
- Study completion
- 27 Dec 2019 (estimated)
- First posted
- 12 Jun 2017 (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.
Acute post streptococcal glomerulonephritis is an immunologic response of the kidney to infection, characterized by the sudden appearance of edema, hematuria, proteinuria and hypertension . It is essentially a disease of childhood that accounts for approximately 90% of renal disorders in children. The disease occurs especially in children between the ages of 2 and 12 years and young adults, and more often in male than in female .
Detailed description
Acute post streptococcal glomerulonephritis are caused by group A beta haemolytic streptococci and follow upper airway infections such as pharyngitis or tonsillitis, by 14 to 21 days and 3-6 weeks after skin infection especially in warmer climates .
In recent decades the number of patients with post streptococcal glomerulonephritis has decreased considerably in the United States and Europe industrialized countries. In other parts of the world ,some developing communities. the incidence of post streptococcal glomerulonephritis has remained high. post streptococcal glomerulonephritis is one of the leading cause requiring hospital admissions in children , and it is also an important cause of acute renal failure in developing countries. Though deaths due to this disease are rare, it can cause serious complications such as hypertensive emergency, congestive cardiac failure, renal failure, encephalopathy and retinopathy .
Acute post streptococcal glomerulonephritis can also progress to rapidly progressive glomerulonephritis which is defined as''a syndrome that progresses rapidly within a few weeks or months to renal failure and is accompanied by urinary findings of nephritis.'' The clinical concept of rapidly progressive glomerulonephritis includes various renal diseases that cause renal function to deteriorate over a subacute course. Necrotizing crescentic glomerulonephritis is often observed in histopathological findings .
Acute post streptococcal glomerulonephritis was diagnosed in the presence of :
features of acute nephritic syndrome. evidence of recent streptococcal infection. lower serum complement three levels. Anti streptolysin o titre >200 units/ml was considered as evidence of recent streptococcal infection
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This study will be done on children attending at Assiut University Children Hospital with clinical manifestation of acute post streptococcal glomerulonephritis during one year period . In addition to meticulous history taking and thorough clinical examination , all the cases will be subjected to the following laboratory investigations : Complete blood count on admission, urine analysis, blood urea, serum creatinine, serum albumin, serum cholesterol, urine spot protein creatinine ratio, antistreptolysin O , Erythrocyte sedimentation rate , C-reactive protein and serum complement C3 levels on admission and after 8 weeks.
Key inclusion criteria (1 listed)
- Children in the age groups of 2-15 years. presenting with clinical manifestation of acute nephritic syndrome will be included in the study.
Key exclusion criteria (4 listed)
- Children having history suggestive of chronic renal and cardiac disease in the past
- Children with congenital renal anomalies .
- Children with clinical manifestation of nephrotic syndrome .
- Children with clinical manifestation of acute nephritic syndrome due to other causes .
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 |
|---|---|---|
| anti streptolysin o titre and serum complement testdiagnostic lab test | Diagnostic test | – |
Primary outcome
number of patients with full recovery or having complication at time of discharge and after 8 week
Time frame: one year
serum complementary test by ELISA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Background: PubMed 10232333Couser WG. Glomerulonephritis. Lancet. 1999 May 1;353(9163):1509-15. doi: 10.1016/S0140-6736(98)06195-9.
- Background: PubMed 27099135Arimura Y, Muso E, Fujimoto S, Hasegawa M, Kaname S, Usui J, Ihara T, Kobayashi M, Itabashi M, Kitagawa K, Hirahashi J, Kimura K, Matsuo S. Evidence-based clinical practice guidelines for rapidly progressive glomerulonephritis 2014. Clin Exp Nephrol. 2016 Jun;20(3):322-41. doi: 10.1007/s10157-015-1218-8. No abstract available.
- Results publication: PubMed 9090652Arora P, Kher V, Rai PK, Singhal MK, Gulati S, Gupta A. Prognosis of acute renal failure in children: a multivariate analysis. Pediatr Nephrol. 1997 Apr;11(2):153-5. doi: 10.1007/s004670050247.
- Results publication: PubMed 12746805Barbiano Di Belgiojoso G, Genderini A, Ferrario F. [Post-infectious glomerulonephritis]. G Ital Nefrol. 2003 Mar-Apr;20(2):184-99. Italian.
- Results publication: PubMed 12572934Matsukura H, Ohtsuki A, Fuchizawa T, Miyawaki T. Acute poststreptococcal glomerulonephritis mimicking Henoch-Schonlein purpura. Clin Nephrol. 2003 Jan;59(1):64-5. doi: 10.5414/cnp59064. No abstract available.
- Results publication: PubMed 17331245Mehta RL, Kellum JA, Shah SV, Molitoris BA, Ronco C, Warnock DG, Levin A; Acute Kidney Injury Network. Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury. Crit Care. 2007;11(2):R31. doi: 10.1186/cc5713.
- Results publication: PubMed 10680980Nordstrand A, Norgren M, Holm SE. Pathogenic mechanism of acute post-streptococcal glomerulonephritis. Scand J Infect Dis. 1999;31(6):523-37. doi: 10.1080/00365549950164382.
- Results publication: PubMed 19384327Kanjanabuch T, Kittikowit W, Eiam-Ong S. An update on acute postinfectious glomerulonephritis worldwide. Nat Rev Nephrol. 2009 May;5(5):259-69. doi: 10.1038/nrneph.2009.44.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of PSGN - Post-Streptococcal Glomerulonephritis, 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 4 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 14 Jun 2017. 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 Mostafa Shafeek, MD (01112110096, Drmostafashafeek20@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients with full recovery or having complication at time of discharge and after 8 week (time frame: one year). 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 NCT03184103, which also lists 8 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 14 Jun 2017.