A Phase 4 interventional study of Cyclosporine Capsule in Nephrotic Syndrome, sponsored by Alexandria University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-11.
Sponsored by Alexandria University · Phase 4, Interventional, and Treatment
Among 10 studies in Nephrotic Syndrome with a site in Egypt — 5 open to participants now, 6 under way, 1 of them phase 3. Nephrotic Syndrome · Egypt.
Among the 10 studies in Nephrotic Syndrome with a site in Egypt, this one is one of 3 that started in 2022, is one of 3 in phase 4, and was the 2nd registered.
191 studies on the registry are indexed under Nephrotic Syndrome; 65 are open to participants now.
Browse Nephrotic Syndrome studies →5 of the 10 studies in Nephrotic Syndrome with a site in Egypt are open now. Recruiting first, the newest first:
Mansoura University · Sites in Egypt
Ain Shams University · Sites in Egypt
Sohag University · Sites in Egypt
Mansoura University · Sites in Egypt
A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →
Of the 50 Nephrotic Syndrome studies recruiting now, 23 (46%) set no upper age limit and 22 (44%) stop at 75 or younger; 37 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
First in 2022; this study’s year is marked. 3 started in 2022.
This study's planned enrollment of 74 is above the median of 46 across 122 interventional studies indexed under Nephrotic Syndrome.
Median enrollment 60 across the 7 interventional studies, 50 across the 3 observational. Of the 3 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 10 has an industry lead sponsor. The 5 most frequent:
Alexandria University is the lead sponsor of 604 studies on the registry; 140 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Alexandria University has 1 study filed under Nephrotic Syndrome — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Nephrotic Syndrome with a site in Egypt, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This study aims to assess the effect of obesity on therapeutic response and safety of cyclosporine trough level in nephrotic syndrome patients and calculating a suitable weight-based dose.
All patients will be subjected to :
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Nephrotic obese patients receive Cyclosporine capsule initially according to weight-based dose then modifying the dose according to targeted therapeutic level. To determine the best weight can be used to get the targeted therapeutic level. Correlate with the lipid profile, fat percentage and other anthropometric measures.
Drug: Cyclosporine Capsule
Nephrotic non-obese patients receive Cyclosporine capsule initially according to weight-based dose then modified dose according to targeted therapeutic level.
Drug: Cyclosporine Capsule
Determination of the most appropriate weight based dose of Cyclosporine to achieve the target therapeutic drug level and response and its relation with fat percentage and lipid profile
Cyclosporine level concentration and its correlation to anthropometric measures
Measuring of Cyclosporine level in whole blood after one month of starting the drug
Time frame: 1 month
Determine a suitable weight-based dose for obese patients
Modifying the Cyclosporine dose according to measured trough level
Time frame: 1 month
Measuring the weight as one of anthropometric measures
Measuring anthropometric measures as; weight in kilograms at base line of starting the Cyclosporine regimen.
Time frame: Day 1
Measuring the height as one of anthropometric measures
Measuring anthropometric measures as;height in metres at base line of starting the Cyclosporine regimen.
Time frame: Day 1
Measuring the BMI as one of anthropometric measures
Measuring anthropometric measures as; BMI (body mass index) in kilograms/meter\^2 at base line of starting the Cyclosporine regimen.
Time frame: Day 1
Measuring some of important in-body anthropometric measures
Measuring anthropometric measures as;body fat percentage, body water percentage and muscle percentage content at base line of starting the Cyclosporine regimen.
Time frame: Day 1
Assessment of kidney functions
Measuring parameters represent the kidney functions including (serum creatinine in mg/dl.)
Time frame: 1 month
Assessment of kidney functions as clearance estimation
Measuring parameters represent the kidney functions including (estimated GFR in mL/min/1.73 m²)
Time frame: 1 month
Assessment of kidney functions as urinary protein release
Measuring parameters represent the kidney functions including (Urinary protein-creatinine ratio in gm/gm)
Time frame: 1 month
Lipid profile assessment
Measuring lipid profile including (HDL, LDL,VLDL and TG) in mg/dl.
Time frame: 1 month
Thyroid function assessment
Measuring Thyroid profile including (TSH, fT3, fT4 ).
Time frame: 1 month
Covid-19 vaccine status assessment
Assess if the patient received Covid-19 vaccine, or not.
Time frame: Day 1
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2022 (actual). Primary completion is estimated for Feb 2024, 22 months after the start.
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Studies of the drug tested here: Cyclosporine