ट्रायल रडार AI | ||
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क्लिनिकल ट्रायल NCT05734794 (STORM) के लिए बच्चों में नेफ्रोटिक सिंड्रोम, रिटुक्सिमैब वर्तमान में भर्ती जारी है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें। | ||
एक परीक्षण फ़िल्टर मानदंडों से मेल खाता है
कार्ड दृश्य
Study of Rituximab Monotherapy on Children With New-onset Nephrotic Syndrome: A Randomized Controlled Trial (STORM) चरण III 80 रैंडमाइज़्ड
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'अध्ययन समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल ट्रायल NCT05734794 (STORM) का मुख्य उद्देश्य उपचार का अध्ययन करना है। यह चिकित्सकीय अध्ययन बच्चों में नेफ्रोटिक सिंड्रोम, रिटुक्सिमैब से जुड़ा हुआ है और यह एक चरण III हस्तक्रियात्मक परीक्षण है। परीक्षण वर्तमान में भर्ती जारी चल रहा है। इसकी शुरुआत 9 फ़रवरी 2023 को हुई थी, और इसमें कुल 80 प्रतिभागियों के नामांकन की योजना है। The Children's Hospital of Zhejiang University School of Medicine इस परीक्षण का नेतृत्व कर रहे हैं और इसके 30 जुलाई 2026 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 25 अगस्त 2023 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
The main objective is to evaluate the effectiveness of Rituximab monotherapy versus steroid therapy on children with new-onset nephrotic syndrome within the 52-week follow-up.
विस्तृत विवरण
Nephrotic syndrome(NS) -------the most common glomerular disease in children. Steroid, as the mainstream therapy for decades, many patients suffer from adverse effects of it, such as growth impacted, fat, and glaucoma.There is a urgent need for Steroid-sparing therapy. Rituximab, as a chemical monoclonal antibody against the cluster of differentiation antigen 20(CD20), has proved to be effective in patients with freq...और दिखाएँ
आधिकारिक शीर्षक
Study of Rituximab Monotherapy VS Steroid Therapy on Children With New-onset Nephrotic Syndrome: A Randomized Controlled Trial
स्वास्थ्य स्थितियां
बच्चों में नेफ्रोटिक सिंड्रोमरिटुक्सिमैबप्रकाशन
इस नैदानिक परीक्षण के बारे में प्रकाशित वैज्ञानिक लेख और शोध पत्र:अन्य अध्ययन आईडी
- STORM
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2023-02-09
अंतिम अद्यतन प्रकाशित
2023-08-25
अध्ययन की समाप्ति तिथि (अनुमानित)
2026-07-30
नामांकन (अनुमानित)
80
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
चरण III
स्थिति
भर्ती जारी
प्रमुख शब्द
Rituximab
Glucocorticosteroids
Glucocorticosteroids
प्राथमिक उद्देश्य
उपचार
डिज़ाइन आवंटन
यादृच्छिक
हस्तक्षेप मॉडल
समानांतर
अंधकरण
कोई नहीं (खुला लेबल)
समूह/हस्तक्षेप
| प्रतिभागी समूह/शाखा | हस्तक्षेप/उपचार |
|---|---|
प्रयोगात्मकRituximab Group Rituximab dose: 4 doses of 375 mg/m2 rituximab at 1-week intervals( within +7 days). | रिटुक्सिमैब Rituximab dose: 4 doses of 375 mg/m2 rituximab at 1-week intervals( within +7 days), associated with trimethoprim-sulfamethoxazole(25-50 mg/kg/day orally twice per day, 3 days per week. If the patient is not allergic) for three months from the first rituximab dosing date(Day 1). Four doses of rituximab are necessary whether the patient achieves complete remission. |
सक्रिय तुलना समूहSteroid Group Daily oral prednisone/prednisolone 2 mg/kg/d (maximum 60 mg/d) for 6 weeks followed by alternate day prednisone/prednisolone, 1.5 mg/kg (maximum of 50 mg), for other 6 weeks. | स्टेरॉयड Daily oral prednisone/prednisolone 2 mg/kg/d (maximum 60 mg/d) for 6 weeks followed by alternate day prednisone/prednisolone, 1.5 mg/kg (maximum of 50 mg), for other 6 weeks. Vitamin D and calcium(adjusted according to the blood calcium level) were administered for three months. |
प्राथमिक परिणाम माप
द्वितीयक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Recurrence-free survival time(day) after first complete remission | The time from complete remission to the first relapse during the whole 52-week follow-up in patients who achieve complete remission within 6 weeks. In order to evaluate the remission, all the participants will document their proteinuria. Relapse is defined by first-morning urine dipstick ≥3+ on three or more consecutive days, 24-h PCR≥2.0g/g, or 24-h urine protein ≥ 50mg/kg, with or without edema after complete remission(KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases). Complete remission is defined by the first morning or 24h PCR ≤ 0.2g/g (or negative or trace dipstick) on three or more consecutive occasions(KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases). | From complete remission to 52 weeks |
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Complete remission of nephrotic syndrome | Complete remission is defined by the first morning or 24h PCR ≤ 0.2g/g (or negative or trace dipstick) on three or more consecutive occasions (KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases). It will be recorded as "1" when patients achieve complete remission, or as "0". | From admission day to 6 weeks |
Inefficiency of nephrotic syndrome | Inefficiency is defined as patients still have nephrotic-range proteinuria(first-morning urine dipstick ≥3+dipstick, 24-h PCR≥2.0g/g, or 24-h urine protein ≥ 50mg/kg) after 6-week treatment. | From admission day to 6 weeks |
The time(day) to first complete remission | The time(day) from the first medicine administration to complete remission within 6 weeks.Complete remission is defined by the first morning or 24h PCR ≤ 0.2g/g (or negative or trace dipstick) on three or more consecutive occasions (KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases). | From admission day to 6 weeks |
Relapse of nephrotic syndrome | Relapse is defined as patients who have first-morning urine dipstick ≥3+ on three or more consecutive days, 24-h PCR≥2.0g/g, or 24-h urine protein ≥ 50mg/kg, with or without edema after complete remission(KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases). It will be recorded as "1" when patients have a relapse, or as "0". | From admission day to 52 weeks |
Cumulative prednisone dosage of each individual (milligrams per kilogram per year) | The total dosage of prednisone for each individual from the beginning to the end of the trial. | From admission day to 52 weeks |
भागीदारी सहायक
पात्रता मानदंड
अध्ययन के लिए पात्र आयु
बच्चा
अध्ययन के लिए न्यूनतम आयु
2 Years
अध्ययन के लिए पात्र लिंग
सभी
- New-onset idiopathic nephrotic syndrome
- Glomerular filtration rate (eGFR) ≥90 ml/min per 1.73 m2 at study entry.
- Glomerular hematuria: Urine red blood cell counts≥ 10/high power field(HP), ≥ 3 times within 2 weeks;
- Continuous hypocomplementaemia(< 0.9g/L) ;
- Repeated or persistent Hypertension(systolic and/or diastolic blood pressures measured greater than the 95th percent of blood pressure in children matching sex, age and height ≥3 different time points)
- Diagnosis of secondary NS, such as secondary to Systemic Lupus Erythematosus, Immunoglobulin A Vasculitis(IgAV), diabetes, Hepatitis B virus(HBV) infection, etc.
- Complicated with other kidney diseases, such as multiple renal cysts, ANCA vasculitis, urinary system abnormalities, etc;
- With a family history of nephrotic syndrome, chronic glomerulonephritis, uremia, or other kidney diseases;
- Other monogenic genetic diseases known as the effect the condition of nephrotic syndromes, such as Wilms' tumor 1(WT1), NPHS2, LAMB2, PLCE1, etc.
- Congenital or acquired immunodeficiency, or patients with active tuberculosis, active Epstein-Barr virus and cytomegalovirus(CMV), acute hepatitis B, hepatitis C, HIV infection, deep fungal infection or other active infections.
- Laboratory indicators were abnormal, such as moderate or severe neutropenia(≤1000/μL)， moderate or severe anemia(hemoglobin<9.0g/dL), Thrombocytopenia (platelet count<100* 10^12/L) or with abnormal hepatic function (Alaninetransaminase(ALT), aspartate Aminotransferase(AST) or bilirubin >2.5*upper limit of normal value and continue to increase for 2 weeks);
- Steroid or immunosuppressive medicine for other diseases within 3 months, such as cyclophosphamide, cyclosporine, tacrolimus, mycophenolate mofetil, tripterygium wilfordii, etc.
- With tumor, severe cardiac failure, severe hepatologic diseases, hematological diseases, or other severe system diseases.
- Patients who are known to be allergic to rituximab;
- History of transplantation, excluding cornea or hair transplantation;
- The attenuated live vaccine was inoculated within 1 month before enrollment;
- Patients who participated in other clinical trials within three months before enrollment;
- Patients are not suitable for inclusion in the trial by any investigator.
The Children's Hospital of Zhejiang University School of Medicineअध्ययन उत्तरदायी पक्ष
Mao Jianhua, मुख्य अन्वेषक, Associate Dean, The Children's Hospital of Zhejiang University School of Medicine
अध्ययन केंद्रीय संपर्क
संपर्क: Jianhua Mao, PHD.MD, 86057186670015, [email protected]
संपर्क: Fei Liu, [email protected]
1 1 देशों में अध्ययन स्थान
Zhejiang
Children's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Li Qiu-Yu, संपर्क, 17794588355, [email protected]
भर्ती जारी