Health TrialsbyHealthPanel

Combination of Rituximab and Cyclosporine in the Treatment of Primary Membranous Nephropathy

ConditionMembranous Nephropathy
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPeking University First Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Rituximab combined with cyclosporine

    Drug

    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.

  • rituximab

    Drug

    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.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: combination therapyActive comparator 1 intervention
Group B: monotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Remission Status

the proportion of subjects to reach the composite of maintaining complete remission or partial remission at 3 months after randomization

Time frame
At 3 months after randomization

Secondary outcomes

1

Remission at 6 months and 12 months

The proportions of patients achieving complete remission or partial remission at 6 and 12 months of treatment.

Time frame
From enrollment to the end of follow-up at 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University First Hospital

Lead sponsor

China Rehabilitation Research Center

Collaborator

Fu Xing Hospital, Capital Medical University

Collaborator

People's Hospital of Beijing Daxing District

Collaborator

Source ClinicalTrials.gov
Apply now