- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05588869
Cyclosporine Adverse Outcomes in Steroid Dependent and Frequent Relapsing Nephrotic Syndrome in Children;Single Center Study
October 17, 2022 updated by: Mahmoud Talaat Mahmoud Abdelaal, Sohag University
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 Overview
Status
Not yet recruiting
Study Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mahmoud T Mahmoud, resident doctor
- Phone Number: 01283228259
- Email: mahmoudtallat@med.sohag.edu.eg
Study Contact Backup
- Name: mustafa M Abosdera, professor
Study Locations
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Sohag, Egypt
- Sohag University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 months to 13 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
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
Description
Inclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
observation of the side effects of cyclosporine in steroid dependent and frequent relapsing nephrotic syndrome in children
Time Frame: 6 months
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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
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Ehren 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.
- Kuroyanagi 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.
- Hampson 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 20, 2022
Primary Completion (Anticipated)
April 20, 2023
Study Completion (Anticipated)
April 20, 2023
Study Registration Dates
First Submitted
October 17, 2022
First Submitted That Met QC Criteria
October 17, 2022
First Posted (Actual)
October 20, 2022
Study Record Updates
Last Update Posted (Actual)
October 20, 2022
Last Update Submitted That Met QC Criteria
October 17, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Kidney Diseases
- Urologic Diseases
- Disease
- Syndrome
- Nephrotic Syndrome
- Nephrosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Antifungal Agents
- Calcineurin Inhibitors
- Cyclosporine
- Cyclosporins
Other Study ID Numbers
- Soh-Med-22-10-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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