Cyclosporin A Therapy in Childhood Nephrotic Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-01

Study Completion Date

2019-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Nephrotic syndrome (NS) is among the most common pediatric kidney diseases and is defined as massive proteinuria (\>40 mg/m2/h or urine protein to creatinine ratio \>2 g/g) leading to hypoalbuminemia (\<2.5 g/dL), edema, and hyperlipidemia. 60-70 % of patients present prior to age of 6 years

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

An Extension Study Designed to Assess Effects of Losartan on Proteinuria in Pediatric Populations (MK-0954-326 AM1,EXT1(AM2))

NCT00568178

Proteinuria

COMPLETED PHASE3

Efficacy and Safety Study to Delay Renal Failure in Children With Alport Syndrome

NCT01485978

Renal Insufficiency, Chronic

COMPLETED PHASE3

Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases

NCT05003986

Focal Segmental Glomerulosclerosis Minimal Change Disease Immunoglobulin A Nephropathy +2 more

RECRUITING PHASE2

Long Term Tapering or Standard Steroids for Nephrotic Syndrome

NCT00308321

Nephrotic Syndrome

UNKNOWN PHASE4

Angiotensin-converting Enzyme Inhibitors and Early Sickle Cell Renal Disease in Children

NCT01096121

Sickle Cell Disease

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

. Most children with NS are treated initially with oral corticosteroids, and they can be clinically classified based on their ability to achieve remission (i.e., complete normalization of proteinuria). Approximately 85 % of children under the age of 6 years are steroid-sensitive, whereas the remainder have steroid-resistant disease. Older children are more likely to have steroid-resistant NS. Children with steroid-resistant disease may have an underlying genetic cause for NS, and providers should consider genetic testing in this population, depending on the age of the child . While inherited causes of NS are often resistant to all therapies, there are reports of complete or partial remission in some children .

For those children who respond to steroids, the majority will have one or more relapses and half will have frequently relapsing (≥4 relapses/year) or steroid-dependent (two consecutive relapses during steroid therapy or within 14 days of stopping steroids). NS Children with frequently relapsing NS and steroid-dependent NS may have significant side effects from cumulative corticosteroid therapy so treatment with other agents is often required .

Cyclosporine and tacrolimus are calcineurin inhibitors that are commonly used as immunosuppressive agents in solid organ transplantation. CNIs are recommended as first-line therapy for children with steroid-resistant NS and as steroid-sparing agents for children with frequently relapsing or steroid-dependent NS .Calcineurin inhibitors (CNIs) inhibit T-cell activation and may be exerting their effect in nephrotic syndrome through this mechanism.

Alternately, cyclosporine has been shown to directly target the podocyte and stabilize the actin cytoskeleton responsible for maintaining cell shape(5) .. Although the majority of studies in nephrotic syndrome have been performed with cyclosporine, tacrolimus appears to be equally efficacious.

Cyclosporin A therapy is well recognised regarding its steroid sparing effect in steroid dependant patients and is responsible for maintaining remission in more than 75% of patients with Steroid dependent nephrotic syndrome even after discontinuation of steroids Furthermore, it has been shown to be effective in inducing remission in steroid resistant nephrotic syndrome. However ,Cyclosporin A is associated with a plethora of side effects such as hypertension, nephrotoxicity hypertrichosis, gum hyperplasia, gastrointestinal disturbances and tremor.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Steroid Dependent and Steroid Resistent Nephrotic Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

serum protein ,kidney function ,liver function.,serum cholesterol

monthly review of serum protein kidney function ,liver function and serum cholesterol in all patients

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* The study will include all children (on cyclosporine therapy for treatment of Steroid dependent or Steroid resistant nephrotic syndrome ) who present to Nephrology Unit , and clinic at Assiut University Children Hospital during one year duration.