- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07861204
Combination of Rituximab and Cyclosporine in the Treatment of Primary Membranous Nephropathy
Efficacy and Safety of Rituximab Combined With Cyclosporine for Primary Membranous Nephropathy
High-grade proteinuria is one of the key determinants of adverse renal prognosis in patients with primary membranous nephropathy (PMN).The main purpose of this study is to determine whether Rituximab combined with Cyclosporine is superior to Rituximab monotherapy in inducing remission of proteinuria in patients with PMN.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Primary membranous nephropathy (PMN) is one of the most common causes of nephrotic syndrome among Chinese adults. For patients with high-grade proteinuria , immunosuppressive therapy is needed. B cell-depleting agent Rituximab is a recommended treatment Regimen in maintaining remission but the response to Rituximab is relatively slow. Calcineurin inhibitors lead to earlier reductions in proteinuria but presenting higher relapse rates in the long follow-up period.Combination therapy may provide both earlier proteinuria remission and durable effect. This is a multi-center, randomized, open-label study conducted in adult patients with biopsy-proven PMN. The main purpose of this study is to determine whether Rituximab combined with Cyclosporine is superior to Rituximab monotherapy in inducing remission of proteinuria in patients with PMN.
Studietype
Registrering (Antatt)
Fase
- Fase 2
- Fase 3
Kontakter og plasseringer
Studiekontakt
- Navn: Fang Wang, Doctor
- Telefonnummer: 01083572388
- E-post: wangfang@bjmu.edu.cn
Studiesteder
-
-
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Beijing, Kina
- Rekruttering
- Peking University First Hospital
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Ta kontakt med:
- Fang Wang
- Telefonnummer: 86-10-83572388
- E-post: wangfang@bjmu.edu.cn
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Age 18-80 years.
- Primary membranous nephropathy confirmed by renal biopsy.
- 24-hour urinary protein quantification > 5.0 g/24h and serum albumin < 30 g/L after at least 3 months of treatment with RAAS blockers.
- eGFR ≥ 40 mL/min/1.73 m².
- Well-controlled blood pressure (≤140/90 mmHg) in the recent 3 months.
- Signed informed consent form.
Exclusion Criteria:
- Secondary causes of membranous nephropathy, such as that secondary to systemic lupus erythematosus, malignant tumors, hepatitis B virus infection, heavy metal poisoning;
- Coexistence of other types of kidney diseases;
- Use of rituximab within the past 12 months;
- Use of corticosteroids, cyclophosphamide, cyclosporine, mycophenolate mofetil, or leflunomide within the past 3 months;
- Active infection: active tuberculosis, HBsAg positivity or HBV-DNA indicating viral replication, positive HCV antibody, HIV infection;
- New-onset cardiovascular or cerebrovascular diseases within the past 3
- Severe liver disease: AST and ALT > 3 times range upper limit ;
- Uncontrolled severe hypertension;
- Newly diagnosed or recurrent malignant tumors within the past 5 years;
- Coexistent autoimmune diseases;
- Pregnancy, lactation, or recent plans for pregnancy;
- Life expectancy less than 12 months;
- Participation in other clinical trials within the past 3 months;
- Unwillingness to sign the informed consent form;
- Any other condition deemed unsuitable for the study by the investigator.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: combination therapy
Rituximab combined with cyclosporine |
The first cycle of rituximab was given at a dose of 1000 mg i.v. on day 1 and day 15.Patients were retreated with rituximab (1000mg ) when CD20 B-cell count was more than 5 cells/ml.Oral cyclosporine will be started at 3 mg/kg/day and continued for 6 months, followed by a 2-month tapering period. |
|
Aktiv komparator: monotherapy
Rituximab |
The first cycle of rituximab was given at a dose of 1000 mg i.v. on day 1 and day 15.Patients were retreated with rituximab (1000mg ) when CD20 B-cell count was more than 5 cells/ml. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Remission Status
Tidsramme: At 3 months after randomization
|
the proportion of subjects to reach the composite of maintaining complete remission or partial remission at 3 months after randomization |
At 3 months after randomization
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Remission at 6 months and 12 months
Tidsramme: From enrollment to the end of follow-up at 12 months
|
The proportions of patients achieving complete remission or partial remission at 6 and 12 months of treatment. |
From enrollment to the end of follow-up at 12 months
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Mannlige urogenitale sykdommer
- Nyresykdommer
- Urologiske sykdommer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Autoimmune sykdommer
- Sykdommer i immunsystemet
- Glomerulonefritt
- Nefritt
- Glomerulonefritt, Membranøs
- Peptider
- Aminosyrer, peptider og proteiner
- Proteiner
- Polysykliske forbindelser
- Antistoffer, monoklonalt
- Antistoffer
- Immunoglobuliner
- Immunoproteiner
- Blodproteiner
- Serumglobuliner
- Globuliner
- Makrosykliske forbindelser
- Antistoffer, monoklonale, murine-avledede
- Peptider, syklisk
- Cyclosporins
- Rituximab
- Syklosporin
Andre studie-ID-numre
- Ricyclo-pMN
Legemiddel- og utstyrsinformasjon, studiedokumenter
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