Steroid Dependent and Frequent Relapsing Nephrotic SyndromeNCT05588869
Cyclosporine Adverse Outcomes in Steroid Dependent and Frequent Relapsing Nephrotic Syndrome in Children;Single Center Study
An observational study of Steroid Dependent and Frequent Relapsing Nephrotic Syndrome, run by Sohag University at 1 site in Egypt.
Trial summary
Nephrotic syndrome (NS) is the most common glomerular disorder in children with significant morbidity and mortality and affects about 1-3 per 100,000 children aged below 16 years. Read more about this study
- Who is it for?
- Ages 1 year to 15 years
- Conditions the study is for
- Steroid Dependent and Frequent Relapsing Nephrotic Syndrome
- What is being tested?
- observation of the adverse outcomes of Cyclosporine in steroid dependent and frequent relapsing nephrotic syndrome in children
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Oct 2022to 20 Apr 2023
- 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 year to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: children and adolescents diagnosed as steroid dependent and frequent relapsing nephrotic syndrome with disease onset from one to fifteen years and treated with cyclosporine A in the Paediatric nephrology clinic, Sohag University Hospital
Who may be able to join
- The study will include children and adolescents diagnosed as steroid dependent and frequent relapsing nephrotic syndrome with disease onset from one to fifteen years and treated with cyclosporine A in the Paediatric nephrology clinic, Sohag University Hospital
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
mustafa M Abosdera, professor contact
About this study
Nephrotic syndrome (NS) is the most common glomerular disorder in children with significant morbidity and mortality and affects about 1-3 per 100,000 children aged below 16 years. Nephrotic syndrome is characterized by the presence of edema, proteinuria: uPCR (urine protein creatinine ratio) ≥200 mg/mmol (≥2 g/g) or 3+ protein on urine dipstick and hypoalbuminemia less than 3 g/dl).Nephrotic syndrome is classified according to response to steroids into steroid sensitive and steroid resistant. Approximately 90% of all cases are steroid-sensitive with an initial episode successfully treated with a standardized treatment protocol of steroids. However, about 80% of these patients experience further relapses. Of these, 50% are steroid dependent and frequent relapsers. While any relapse can be treated with steroids, children may be vulnerable to the side effects of a high cumulative dose of steroids such as obesity, growth impairment, behavioral alterations and attention problems, as well as reduced quality of life and family stress. To minimize steroid toxicity in patients with steroid-dependent and frequently relapsing nephrotic syndrome, a number of immunosuppressive agents are recommended as maintenance therapeutic agents. Among those are cyclosporine A, tacrolimus, mycophenolate mofetil (MMF), cyclophosphamide, levamisole and rituximab. Cyclosporin-A (CsA) is a calcineurin inhibitor that is well recognized as having a steroid sparing effect in steroid-dependent and frequently relapsing NS and has a role in the maintenance of complete remission in more than 75% of patients with SDNS during discontinuation of steroids. However, early withdrawl of cysclosporine may lead to relapses so the patient may be dependent on cyclosporine for years. The long-term use of CsA has been identified to be a risk factor of unsatisfactory effects such as nephrotoxicity, hypertension and cosmetic symptoms such as (gum hypertrophy and hirsutism). Therefore, close observation of the side effects of cyclosporine is very important as well as regular follow up of blood pressure and kidney function tests. Also, estimation of trough blood levels of CsA is required in patients with suspected non compliance, unsatisfactory response or nephrotoxicity (increase in serum creatinine by 30% or more from the baseline) aiming for the lowest levels that maintain remission and avoid toxicity (target 12-hr trough level of 60-150 ng/ml). Kidney biopsy could be included as a component of the long-term CsA protocol to test for CsA-associated nephropathy if given more than 2-3 years. CsA nephrotoxicity is primarily caused by chronic ischemic insult to the kidney, resulting in arteriolar hyalination and tubulointerstitial changes, including striped interstitial fibrosis, tubular vacuolization, and atrophy.The aim of this study is to determine the adverse outcomes of Cyclosporine in children with steroid dependent and frequent relapsing nephrotic syndrome in Sohag University Hospital.
- Being tested
- observation of the adverse outcomes of Cyclosporine in steroid dependent and frequent relapsing nephrotic syndrome in children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observation of the adverse outcomes of Cyclosporine in steroid dependent and frequent relapsing nephrotic syndrome in childrenOther
The interventions that will be done include collection of the following data : age at disease onset, disease duration, type of steroid response, age at the start of CsA treatment, dose and duration of CsA treatment, mean values of the maintenance doses of CsA and their trough blood levels and observation of the side effects. serum creatinine at regular intervals before and after CsA treatment and renal biopsy for those who are on CsA for more than 2-3 years would be done.
What is being measured
The primary outcome is the main question the study is designed to answer.
observation of the side effects of cyclosporine in steroid dependent and frequent relapsing nephrotic syndrome in children
observation and follow up of unsatisfactory effects of cyclosporine such as nephrotoxicity, hypertension and cosmetic symptoms such as (gum hypertrophy and hirsutism).serum creatinine at regular intervals before and after CsA treatment, renal biopsy for those who are on CsA for more than 2-3 years
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start20 Oct 2022 (estimated)
- Primary completion20 Apr 2023 (estimated)
- Study completion20 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Steroid Dependent and Frequent Relapsing Nephrotic SyndromeStudies 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
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Talaat Mahmoud Abdelaal, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05588869
- Sponsor's protocol ID
- Soh-Med-22-10-01
- Status last verified
- Oct 2022
- First submitted
- 17 Oct 2022
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kidney Disease: Improving Global Outcomes (KDIGO) Glomerular Diseases Work Group. KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases. Kidney Int. 2021 Oct;100(4S):S1-S276. doi: 10.1016/j.kint.2021.05.021. No abstract available.
PubMed 34556256Ehren R, Benz MR, Brinkkotter PT, Dotsch J, Eberl WR, Gellermann J, Hoyer PF, Jordans I, Kamrath C, Kemper MJ, Latta K, Muller D, Oh J, Tonshoff B, Weber S, Weber LT; German Society for Pediatric Nephrology. Pediatric idiopathic steroid-sensitive nephrotic syndrome: diagnosis and therapy -short version of the updated German best practice guideline (S2e) - AWMF register no. 166-001, 6/2020. Pediatr Nephrol. 2021 Oct;36(10):2971-2985. doi: 10.1007/s00467-021-05135-3. Epub 2021 Jun 6.
PubMed 34091756Kuroyanagi Y, Gotoh Y, Kasahara K, Nagano C, Fujita N, Yamakawa S, Yamamoto M, Takeda A, Uemura O. Effectiveness and nephrotoxicity of a 2-year medium dose of cyclosporine in pediatric patients with steroid-dependent nephrotic syndrome: determination of the need for follow-up kidney biopsy. Clin Exp Nephrol. 2018 Apr;22(2):413-419. doi: 10.1007/s10157-017-1444-3. Epub 2017 Jul 11.
PubMed 28699031Hampson KJ, Gay ML, Band ME. Pediatric Nephrotic Syndrome: Pharmacologic and Nutrition Management. Nutr Clin Pract. 2021 Apr;36(2):331-343. doi: 10.1002/ncp.10622. Epub 2021 Jan 19.
PubMed 33469930
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cyclosporine Adverse Outcomes in Steroid Dependent and Frequent Relapsing Nephrotic Syndrome in Children;Single Center Study
- ClinicalTrials.gov ID
- NCT05588869
- Acronym / sponsor ID
- Soh-Med-22-10-01
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 20 Oct 2022 (estimated)
- Primary completion
- 20 Apr 2023 (estimated)
- Study completion
- 20 Apr 2023 (estimated)
- First posted
- 20 Oct 2022 (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.
Nephrotic syndrome (NS) is the most common glomerular disorder in children with significant morbidity and mortality and affects about 1-3 per 100,000 children aged below 16 years. Nephrotic syndrome is characterized by the presence of edema, proteinuria: uPCR (urine protein creatinine ratio) ≥200 mg/mmol (≥2 g/g) or 3+ protein on urine dipstick and hypoalbuminemia less than 3 g/dl).Nephrotic syndrome is classified according to response to steroids into steroid sensitive and steroid resistant. Approximately 90% of all cases are steroid-sensitive with an initial episode successfully treated with a standardized treatment protocol of steroids. However, about 80% of these patients experience further relapses. Of these, 50% are steroid dependent and frequent relapsers. While any relapse can be treated with steroids, children may be vulnerable to the side effects of a high cumulative dose of steroids such as obesity, growth impairment, behavioral alterations and attention problems, as well as reduced quality of life and family stress. To minimize steroid toxicity in patients with steroid-dependent and frequently relapsing nephrotic syndrome, a number of immunosuppressive agents are recommended as maintenance therapeutic agents. Among those are cyclosporine A, tacrolimus, mycophenolate mofetil (MMF), cyclophosphamide, levamisole and rituximab. Cyclosporin-A (CsA) is a calcineurin inhibitor that is well recognized as having a steroid sparing effect in steroid-dependent and frequently relapsing NS and has a role in the maintenance of complete remission in more than 75% of patients with SDNS during discontinuation of steroids. However, early withdrawl of cysclosporine may lead to relapses so the patient may be dependent on cyclosporine for years. The long-term use of CsA has been identified to be a risk factor of unsatisfactory effects such as nephrotoxicity, hypertension and cosmetic symptoms such as (gum hypertrophy and hirsutism). Therefore, close observation of the side effects of cyclosporine is very important as well as regular follow up of blood pressure and kidney function tests. Also, estimation of trough blood levels of CsA is required in patients with suspected non compliance, unsatisfactory response or nephrotoxicity (increase in serum creatinine by 30% or more from the baseline) aiming for the lowest levels that maintain remission and avoid toxicity (target 12-hr trough level of 60-150 ng/ml). Kidney biopsy could be included as a component of the long-term CsA protocol to test for CsA-associated nephropathy if given more than 2-3 years. CsA nephrotoxicity is primarily caused by chronic ischemic insult to the kidney, resulting in arteriolar hyalination and tubulointerstitial changes, including striped interstitial fibrosis, tubular vacuolization, and atrophy.The aim of this study is to determine the adverse outcomes of Cyclosporine in children with steroid dependent and frequent relapsing nephrotic syndrome in Sohag University Hospital.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children and adolescents diagnosed as steroid dependent and frequent relapsing nephrotic syndrome with disease onset from one to fifteen years and treated with cyclosporine A in the Paediatric nephrology clinic, Sohag University Hospital
Key inclusion criteria (1 listed)
- The study will include children and adolescents diagnosed as steroid dependent and frequent relapsing nephrotic syndrome with disease onset from one to fifteen years and treated with cyclosporine A in the Paediatric nephrology clinic, Sohag University Hospital
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| observation of the adverse outcomes of Cyclosporine in steroid dependent and frequent relapsing nephrotic syndrome in childrenThe interventions that will be done include collection of the following data : age at disease onset, disease duration, type of steroid response, age at the start of CsA treatment, dose and duration of CsA treatment, mean values of the maintenance doses of CsA and their trough blood levels and observation of the side effects. serum creatinine at regular intervals before and after CsA treatment and renal biopsy for those who are on CsA for more than 2-3 years would be done. | Other | – |
Primary outcome
observation of the side effects of cyclosporine in steroid dependent and frequent relapsing nephrotic syndrome in children
Time frame: 6 months
observation and follow up of unsatisfactory effects of cyclosporine such as nephrotoxicity, hypertension and cosmetic symptoms such as (gum hypertrophy and hirsutism).serum creatinine at regular intervals before and after CsA treatment, renal biopsy for those who are on CsA for more than 2-3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
- Background: PubMed 34556256Kidney Disease: Improving Global Outcomes (KDIGO) Glomerular Diseases Work Group. KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases. Kidney Int. 2021 Oct;100(4S):S1-S276. doi: 10.1016/j.kint.2021.05.021. No abstract available.
- Background: PubMed 34091756Ehren R, Benz MR, Brinkkotter PT, Dotsch J, Eberl WR, Gellermann J, Hoyer PF, Jordans I, Kamrath C, Kemper MJ, Latta K, Muller D, Oh J, Tonshoff B, Weber S, Weber LT; German Society for Pediatric Nephrology. Pediatric idiopathic steroid-sensitive nephrotic syndrome: diagnosis and therapy -short version of the updated German best practice guideline (S2e) - AWMF register no. 166-001, 6/2020. Pediatr Nephrol. 2021 Oct;36(10):2971-2985. doi: 10.1007/s00467-021-05135-3. Epub 2021 Jun 6.
- Background: PubMed 28699031Kuroyanagi Y, Gotoh Y, Kasahara K, Nagano C, Fujita N, Yamakawa S, Yamamoto M, Takeda A, Uemura O. Effectiveness and nephrotoxicity of a 2-year medium dose of cyclosporine in pediatric patients with steroid-dependent nephrotic syndrome: determination of the need for follow-up kidney biopsy. Clin Exp Nephrol. 2018 Apr;22(2):413-419. doi: 10.1007/s10157-017-1444-3. Epub 2017 Jul 11.
- Background: PubMed 33469930Hampson KJ, Gay ML, Band ME. Pediatric Nephrotic Syndrome: Pharmacologic and Nutrition Management. Nutr Clin Pract. 2021 Apr;36(2):331-343. doi: 10.1002/ncp.10622. Epub 2021 Jan 19.
- 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.
mustafa M Abosdera, professor contact
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 Steroid Dependent and Frequent Relapsing Nephrotic Syndrome, 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 0 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 20 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud T Mahmoud, resident doctor (01283228259, mahmoudtallat@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
observation of the side effects of cyclosporine in steroid dependent and frequent relapsing nephrotic syndrome in children (time frame: 6 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 NCT05588869, which also lists 4 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 20 Oct 2022.