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Different Immunosuppressive Treatment in iMN

ConditionIdiopathic Membranous Nephropathy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPeking Union Medical College Hospital

About this trial

The primary objective of this study is to compare the 24 month remission of different immunosuppressive therapies in the treatment of idiopathic membranous nephropathy (iMN)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

idiopathic membranous nephropathy

Female, must be post-menopausal, sterile or have effective contraception

must be off steroid or mycophenolate mofetil for >1 month and alkylating agents for or RTX> 6 months

Angiotensin-converting-enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) for ≥ 3 months with controlled blood pressure prior to beginning of immunosuppressive therapy or if patients are intolerant to ACEI/ARB.

Disqualifiers

presence of active infection or a secondary cause of membranous nephropathy

proteinuria associated with diabetic nephropathy

pregnancy or breast feeding

history of resistance to rituximab or alkylating agents or corticosteroid

Trial design

Design model

Parallel

Treatments tested in this trial

  • Prednisone

    Drug

    1mg/kg/d p.o.which will be tapered after 2 months and discontinued over a 6-12 month period.

  • Cyclophosphamide

    Drug

    1-2mg/kg/d p.o. with a target accumulated dose of 12g.

  • Rituximab

    Drug

    1000mg I.V. on D1 and at 6 month. After 6 month, in patients with response but not complete remission, Rituximab could be stopped or repeated with a 6 month-interval (12 month, 18 month, 24 month) until complete remission. Rituximab 1000mg I.V. will be repeated on the 15th day of each Rituximab infusion if CD19+ B cell count\>5/ul.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: cyclophosphamide and prednisoneActive comparator 2 interventions
Group B: RituximabActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

complete or partial remission on 24 month

Complete remission is defined as urine protein \< 0.5g/24h and serum albumin≥ 3.5g/dl. Partial remission is defined as reduction in urine protein≥50% plus urine protein ≤3.5g/24h but \>0.5g/24h

Time frame
24 months

Secondary outcomes

1

complete or partial remission on 6, 12 and 18 month

complete or partial remission on 6, 12 and 18 month

Time frame
6, 12 and 18 months
2

complete remission on 6, 12, 18 and 24 month

complete remission on 6, 12, 18 and 24 month

Time frame
6, 12, 18 and 24 months
3

time to complete or partial remission

time to complete or partial remission

Time frame
from date of treatment until the date of first documented remission, up to 24 months
4

change of estimated glomerular filtration rate (eGFR)

change of estimated glomerular filtration rate (eGFR) from baseline

Time frame
24 months

Other outcomes

Sponsors and contacts

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

Peking Union Medical College Hospital

Lead sponsor

Source ClinicalTrials.gov
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