Nephrotic SyndromePhase 4NCT05696977
Effect of Obesity on Cyclosporine Blood Trough Level in Nephrotic Syndrome Patients
A Phase 4 study testing Cyclosporine Capsule in people with Nephrotic Syndrome, run by Alexandria University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrotic Syndrome
- What is being tested?
- Cyclosporine Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Apr 2022to Apr 2024
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obese and overweight Nephrotic syndrome adult patients receiving Cyclosporine for more than one month with prednisolone. (BMI>25 kg/m2)
- Normal or underweight individuals Nephrotic syndrome adult patients receiving Cyclosporine for more than one month with prednisolone. (serving as control group)
Who cannot join
- Hepatic patients liver cirrhosis (moderate to severe liver impairment)
- Cancer patients,
- Pregnant and lactating female patients
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Alexandria University
Alexandria
Noha A Hamdy, PhD, 01005182151 ext. +2, noha.alaaeldine@alexu.edu.eg
Yasmin S Naga, PhD, 01222244673 ext. +2, yasminenaga@gmail.com
About this study
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.
Read the detailed description
- Ethical committee approval has been obtained from Ethics committee of Faculty of Medicine, Alexandria University.
- Agreement from all participants should be taken in this clinical study by assigning an informed consent.
- Nephrotic diseased patients,will be recruited from Alexandria main university hospital (AMUH).
- The 74 participants will be non-randomly assigned into 2 groups.
- The control group is non-obese nephrotic patients with BMI <25 kg/m2 will receive receive Cyclosporine capsule with conventional initial dose 3 mg/kg/day using actual weight.
- The Case interventional group is Obese nephrotic patients with BMI> 25kg/m2 will receive Cyclosporine capsule with the best weight based dose to achieve the targeted therapeutic trough level and targeted urinary protein/ creatinine ratio.
- All patients will be subjected to :
- First visit: Full patient history, anthropometrics (weight, hight, BMI, fat %, water %, muscles% and clinical examination. Calculate the initial cyclosporine dose 3mg/kg/day in 2 divided doses based on actual weight.
- Second visit after one month: blood sample withdrawal for measuring trough level, lipid profile and thyroid profile, urinary sample to measure uPCR If patients don't reach to targeted therapeutic trough level and targeted urinary protein/ creatinine ratio,re-modifying the dose and repeat the labs after another one month in third visit.
- Finally find the best weight can be used to achieve the targeted therapeutic trough level and targeted urinary protein/ creatinine ratio, and its relation with fat content and lipid profile
- The appropriate Statistical tests will be hold according to study design and parameters (parametric and non-parametric) to evaluate the significance of the results.
- Results, conclusion, discussion and recommendations will be given.
- Conditions
- Nephrotic Syndrome
- Being tested
- Cyclosporine Capsule
- Keywords
- Cyclosporine, Obese patients, Lipoproteins
- Medical subject headings
- Nephrotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclosporine CapsuleDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Obese nephrotic patients with BMI>25 kg/m2 | Active comparator | 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. Receives: Drug: Cyclosporine Capsule |
| Non obese nephrotic patients with BMI<25 kg/m2 | Other | Nephrotic non-obese patients receive Cyclosporine capsule initially according to weight-based dose then modified dose according to targeted therapeutic level. Receives: Drug: Cyclosporine Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cyclosporine level concentration and its correlation to anthropometric measures
Measuring of Cyclosporine level in whole blood after one month of starting the drug
Measured: 1 month
Determine a suitable weight-based dose for obese patients
Modifying the Cyclosporine dose according to measured trough level
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1
Secondary outcomes (6)
Assessment of kidney functions
Measuring parameters represent the kidney functions including (serum creatinine in mg/dl.)
Measured: 1 month
Assessment of kidney functions as clearance estimation
Measuring parameters represent the kidney functions including (estimated GFR in mL/min/1.73 m²)
Measured: 1 month
Assessment of kidney functions as urinary protein release
Measuring parameters represent the kidney functions including (Urinary protein-creatinine ratio in gm/gm)
Measured: 1 month
Lipid profile assessment
Measuring lipid profile including (HDL, LDL,VLDL and TG) in mg/dl.
Measured: 1 month
Thyroid function assessment
Measuring Thyroid profile including (TSH, fT3, fT4 ).
Measured: 1 month
Covid-19 vaccine status assessment
Assess if the patient received Covid-19 vaccine, or not.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start17 Apr 2022
- Primary completionFeb 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephrotic SyndromeStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Open labelled, prospective,non-randomized, two-arms,parallel groups, non-placebo controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696977
- Sponsor's protocol ID
- 0107113
- Status last verified
- Dec 2023
- First submitted
- 15 Dec 2022
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Obesity on Cyclosporine Blood Trough Level in Nephrotic Syndrome Patients
- ClinicalTrials.gov ID
- NCT05696977
- Acronym / sponsor ID
- 0107113
- Conditions
- Nephrotic Syndrome
- Keywords
- Cyclosporine, Obese patients, Lipoproteins
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 17 Apr 2022 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 25 Jan 2023 (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.
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.
Detailed description
- Ethical committee approval has been obtained from Ethics committee of Faculty of Medicine, Alexandria University.
- Agreement from all participants should be taken in this clinical study by assigning an informed consent.
- Nephrotic diseased patients,will be recruited from Alexandria main university hospital (AMUH).
- The 74 participants will be non-randomly assigned into 2 groups.
- The control group is non-obese nephrotic patients with BMI <25 kg/m2 will receive receive Cyclosporine capsule with conventional initial dose 3 mg/kg/day using actual weight.
- The Case interventional group is Obese nephrotic patients with BMI> 25kg/m2 will receive Cyclosporine capsule with the best weight based dose to achieve the targeted therapeutic trough level and targeted urinary protein/ creatinine ratio.
- All patients will be subjected to :
- First visit: Full patient history, anthropometrics (weight, hight, BMI, fat %, water %, muscles% and clinical examination. Calculate the initial cyclosporine dose 3mg/kg/day in 2 divided doses based on actual weight.
- Second visit after one month: blood sample withdrawal for measuring trough level, lipid profile and thyroid profile, urinary sample to measure uPCR If patients don't reach to targeted therapeutic trough level and targeted urinary protein/ creatinine ratio,re-modifying the dose and repeat the labs after another one month in third visit.
- Finally find the best weight can be used to achieve the targeted therapeutic trough level and targeted urinary protein/ creatinine ratio, and its relation with fat content and lipid profile
- The appropriate Statistical tests will be hold according to study design and parameters (parametric and non-parametric) to evaluate the significance of the results.
- Results, conclusion, discussion and recommendations will be given.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open labelled, prospective,non-randomized, two-arms,parallel groups, non-placebo controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Obese nephrotic patients with BMI>25 kg/m2 | Active comparator | Drug: Cyclosporine CapsuleNephrotic 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. |
| Non obese nephrotic patients with BMI<25 kg/m2 | Other | Drug: Cyclosporine CapsuleNephrotic non-obese patients receive Cyclosporine capsule initially according to weight-based dose then modified dose according to targeted therapeutic level. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Obese and overweight Nephrotic syndrome adult patients receiving Cyclosporine for more than one month with prednisolone. (BMI>25 kg/m2)
- Normal or underweight individuals Nephrotic syndrome adult patients receiving Cyclosporine for more than one month with prednisolone. (serving as control group)
Key exclusion criteria (3 listed)
- Hepatic patients liver cirrhosis (moderate to severe liver impairment)
- Cancer patients,
- Pregnant and lactating female patients
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 |
|---|---|---|
| Cyclosporine CapsuleDetermination 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 | Drug | Non obese nephrotic patients with BMI<25 kg/m2, Obese nephrotic patients with BMI>25 kg/m2 |
Primary outcome
Cyclosporine level concentration and its correlation to anthropometric measures
Time frame: 1 month
Measuring of Cyclosporine level in whole blood after one month of starting the drug
Determine a suitable weight-based dose for obese patients
Time frame: 1 month
Modifying the Cyclosporine dose according to measured trough level
Measuring the weight as one of anthropometric measures
Time frame: Day 1
Measuring anthropometric measures as; weight in kilograms at base line of starting the Cyclosporine regimen.
Measuring the height as one of anthropometric measures
Time frame: Day 1
Measuring anthropometric measures as;height in metres at base line of starting the Cyclosporine regimen.
Measuring the BMI as one of anthropometric measures
Time frame: Day 1
Measuring anthropometric measures as; BMI (body mass index) in kilograms/meter^2 at base line of starting the Cyclosporine regimen.
Measuring some of important in-body anthropometric measures
Time frame: Day 1
Measuring anthropometric measures as;body fat percentage, body water percentage and muscle percentage content at base line of starting the Cyclosporine regimen.
6 secondary outcomes
Assessment of kidney functions
Time frame: 1 month
Assessment of kidney functions as clearance estimation
Time frame: 1 month
Assessment of kidney functions as urinary protein release
Time frame: 1 month
Lipid profile assessment
Time frame: 1 month
Thyroid function assessment
Time frame: 1 month
Covid-19 vaccine status assessment
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cyclosporine Capsule in people with Nephrotic Syndrome, run by Alexandria 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 2 inclusion and 3 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 11 Dec 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Enas A Mohamed, PharmD (01004344021 ext. +2, gs-enas.elkady@alexu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cyclosporine level concentration and its correlation to anthropometric measures (time frame: 1 month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2023.