- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05714670
The Effect of Curcumin on the Clinical Outcome of Pediatric Patients With Active Lupus Nephritis
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Sugood Hossam Abdellah
- Phone Number: 01028201483
- Email: sujoud.hosam21@pharma.asu.edu.eg
Study Locations
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-
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Cairo, Egypt
- Recruiting
- Outpatients Clinic of Pediatric Rheumatology department - Children's Hospital, Ain Shams University, Cairo, Egypt.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 1- Lupus nephritis patients both genders aged 16 or younger 2- Biopsy specimens confirmed active lesions or active and chronic lesions defined as nephritis according to WHO classification 3- Children on standard treatment (mycophenolate mofetil + hydroxychloroquine + steroids) 4- Children on another standard regimen: low-dose intravenous cyclophosphamide (CY) (total dose 3 g over 3 months) -monthly pulses 0.5-1 g/m2- in combination with glucocorticoids
Exclusion Criteria:
- Dialysis or B cell-targeted therapy (including belimumab) within the preceding year
- Patients with other comorbidities
- Smokers
- Previous failures of both MMF and CYC induction therapy,
- Estimated glomerular filtration rate (eGFR) of less than 30 ml/min per 1.73 m2 of body surface area.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: standard of care
patients will receive oral MMF initial dose of 1200 mg/m2/day, no more than 2000 mg/day, increased to 1800 mg/m2/day, no more than 3000 mg/day, if response is not good + corticosteroid protocols are: intravenous pulse of methylprednisolone (30 mg/kg/dose for three consecutive days, no more than de 1000 mg/dose), followed by oral prednisolone/prednisone (0.5-1.0 mg/kg/day); or high dosage oral prednisone/prednisolone (1-2 mg/kg/day, no more than 60 mg/day) + hydroxychloroquine 4.0-5.5 mg/kg/day second regimen: low-dose intravenous cyclophosphamide (CY) (total dose 3 g over 3 months) -monthly pulses 0.5-1 g/m2- in combination with glucocorticoids
|
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Experimental: Curcumin Oral Capsule group
patients will receive oral 1000 mg of curcumin capsules daily in addition to their standard treatment for three months. Standard treatment includes: oral MMF initial dose of 1200 mg/m2/day, no more than 2000 m g/day, increased to 1800 mg/m2/day, no more than 3000 mg/day, if response is not good + corticosteroid protocols are: intravenous pulse of methylprednisolone (30 mg/kg/dose for three consecutive days, no more than de 1000 mg/dose), followed by oral prednisolone/prednisone (0.5-1.0 mg/kg/day); or high dosage oral prednisone/prednisolone (1-2 mg/kg/day, no more than 60 mg/day) + hydroxychloroquine 4.0-5.5 mg/kg/day second regimen: low-dose intravenous cyclophosphamide (CY) (total dose 3 g over 3 months) -monthly pulses 0.5-1 g/m2- in combination with glucocorticoids |
Curcumin 1000 mg Oral Capsule beside the standard of care
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
chang is being assessed in Urine protein-to-creatinine ratio from baseline
Time Frame: baseline and week12
|
urine sample will be examined for albumin levels and creatinine levels, normal ratio for paediatrics is less than 0.25
|
baseline and week12
|
change is being assessed in NLPR3 Inflammasome serum levels from baseline
Time Frame: baseline and week12
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serum sample will be examined for NLRP3 inflammasome levels and how it is affected by the tested drug
|
baseline and week12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Erythrocyte sedimentation rate
Time Frame: baseline, week 4, week 8 and week 12
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blood sample is examined for ESR level
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baseline, week 4, week 8 and week 12
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C-reactive protein
Time Frame: baseline, week 4, week 8 and week 12
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blood sample is examined for CRP level
|
baseline, week 4, week 8 and week 12
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Anti-ANA DNA
Time Frame: baseline and week 12
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antinuclear antibody
|
baseline and week 12
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Kidney Diseases
- Urologic Diseases
- Connective Tissue Diseases
- Glomerulonephritis
- Lupus Erythematosus, Systemic
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Nephritis
- Lupus Nephritis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Curcumin
Other Study ID Numbers
- RHDIRB2020110301REC121
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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