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Die klinische Studie NCT07087314 für Nephrotisches Syndrom bei Kindern ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
Eine Studie entspricht den Filterkriterien
Kartenansicht
A Study of Anti-CD38 Monoclonal Antibody (SG301) Subcutaneous Injection in Children With Nephrotic Syndrome With Frequent Relapses or Steroid Dependence Phase 2 30 Monoklonale Antikörper
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT07087314 untersucht Behandlung im Zusammenhang mit Nephrotisches Syndrom bei Kindern. Diese interventionsstudie der Phase 2 hat den Status offene rekrutierung und startete am 25. August 2025. Es ist geplant, 30 Teilnehmer aufzunehmen. Durchgeführt von Mao Jianhua wird der Abschluss für 9. Juli 2029 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 27. Februar 2026 aktualisiert.
Kurzbeschreibung
This is an open - label study to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of SG301 Subcutaneous injection in children with frequently relapsing or steroid - dependent nephrotic syndrome.
Ausführliche Beschreibung
This study will recruit children aged 6 - 18 with frequently relapsing or steroid - dependent nephrotic syndrome, who have morning urine protein < 1 + or urine protein / creatinine < 0.2 g/g (<20 mg/mmol) for at least three consecutive days after steroid treatment.
The study will stratify participants into two age groups:≥6 - <12 years and≥12 - <18 years. Recruitment will start with the 12 - 18 - year - old gro...
Mehr anzeigenOffizieller Titel
A Clinical Study to Evaluate the Initial Efficacy and Safety of Anti-CD38 Monoclonal Antibody (SG301) Subcutaneous Injection in Children With Frequent Relapses or Steroid-Dependent Nephrotic Syndrome
Erkrankungen
Nephrotisches Syndrom bei KindernWeitere Studien-IDs
- CSG-301 SC-204
NCT-Nummer
Studienbeginn (tatsächlich)
2025-08-25
Zuletzt aktualisiert
2026-02-27
Studienende (vorauss.)
2029-07-09
Geplante Rekrutierung
30
Studientyp
Interventionsstudie
PHASE
Phase 2
Status
Offene Rekrutierung
Primäres Ziel
Behandlung
Zuteilungsmethode
Nicht zutreffend
Interventionsmodell
Einarmige Studie
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellSG301 Subcutaneous injection full - dose prednisone (60 mg/m²/day, up to 80 mg) for remission induction. After 3 days of negative urine protein, start SG301 Subcutaneous injection with steroid tapering. Taper prednisolone to 60 mg/m² (max 80 mg) every other day, reducing by 1/6 every 2 weeks, and stop after 3 months. | SG301 Subcutaneous injection Subcutaneous injection every weeks (QW\*6),subsequently, administer it once every two weeks for a total of three times (Q2W\*3). The total number of doses is nine. |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Incidence and rate of treatment-Emergent Adverse Events | Number and percentage of adverse events which are calculated by worst CTCAE grade by CTCAE 5.0 | From baseline through study completion, an average of 1 year |
Relapse free survival rate | Relapse free survival rate at 6 and 12 months | Average 1 year per subject |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Relapse frequency in times | Proportion of relapsed participants | From baseline through study completion, an average of 1 year |
Time to Relapse | Time to first relapse after enrollment | From baseline through study completion, an average of 1 year |
Serum creatinine | Serum creatinine(SCr), SCr in mg/dl | From baseline through study completion, an average of 1 year |
estimated glomerular filtration rate | Estimated glomerular filtration rate (eGFR), eGFR in ml/min/1.73m² | From baseline through study completion, an average of 1 year |
Cumulative corticosteroid dose | The total amount of corticosteroids used during the study period, and the total amount of corticosteroids used in the 6 months prior to enrollment | From baseline through study completion, an average of 1 year |
SG301 anti-drug antibodies | Number of subjects positive for anti-SG301 anti-drug antibodies | From baseline through study completion, an average of 1 year |
Neutralizing antibodies against SG301 | the neutralizing antibody titer of anti-SG301 anti-drug antibodies | From baseline through study completion, an average of 1 year |
pharmacokinetics : Ctrough | The trough concentration of SG301 | From baseline through study completion, an average of 1 year |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Kind, Erwachsene
Mindestalter
6 Years
Zugelassene Geschlechter
Alle
- Aged 6 - 18 years.
- Steroid-sensitive nephrotic syndrome with frequent relapses (FRNS) or steroid dependence (SDNS).
- Normal renal function: eGFR≥90 ml/min/1.73m².
- After steroid treatment, morning urine protein<1 + or urine protein/creatinine<0.2 g/g (<20 mg/mmol) for ≥3 consecutive days.
- Within 7 days before enrollment, blood tests (without growth factors or transfusions) must meet: hemoglobin>80 g/L; platelets>75×10⁹/L; neutrophils>1.5×10⁹/L.
- Prothrombin time/INR≤1.5×ULN, unless due to anticoagulation.
- No Tacrolimus, cyclosporine A, mycophenolate mofetil, belimumab, levamisole, azathioprine, or cyclophosphamide in prior 2 months; no rituximab or obinutuzumab in prior 6 months.
- Family history of nephrotic syndrome, chronic glomerulonephritis, or uremia.
- Alanine aminotransferase >2×ULN or total bilirubin>2×ULN with a sustained increase for 2 weeks.
- HBsAg or HBcAb positive with Hepatitis B virus DNA above the lower limit of normal; Hepatitis C virus antibody - positive with Hepatitis C virus RNA positive; HIV antibody - positive.
- Chronic active infections (e.g., Epstein-Barr Virus, Cytomegalovirus, tuberculosis) that may worsen with steroids/ immunosuppressants.
- Acute active infection (excluding onychomycosis) requiring systemic antibiotics/antivirals.
- Secondary nephrotic syndrome (e.g.,immunoglobulin A - associated, lupus nephritis); steroid - resistant nephrotic syndrome (SRNS).
- Other autoimmune diseases, primary immunodeficiency, or malignancy.
- Prior anti - cluster of differentiation 38 (CD38) treatment.
- Live/attenuated vaccine receipt or major surgery (non - diagnostic) within 4 weeks before first dose.
Mao JianhuaVerantwortliche Partei
Mao Jianhua, Prüfsponsor, Professor, The Children's Hospital of Zhejiang University School of Medicine
Zentrale Studienkontakte
Kontakt: Yanyan Jin, Doctor, +86 19357612502, [email protected]
1 Studienstandorte in 1 Ländern
Zhejiang
Children's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310052, China
Jianhua Mao, Docter, Kontakt
Offene Rekrutierung