Treatment of Patients With Idiopathic Membranous Nephropathy

NCT ID: NCT00135954

Last Updated: 2014-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-07-31
• Study Completion Date: 2008-07-31

Brief Summary

Patients with idiopathic membranous nephropathy at risk for renal failure can be identified in an early stage by measuring urinary low molecular weight proteins and urinary immunoglobulin G (IgG). This study evaluates the possible benefit of early start of immunosuppressive therapy in these high-risk patients.

Detailed Description

Inclusion Criteria:

• patients with idiopathic membranous nephropathy
• nephrotic syndrome
• normal renal function (serum creatinine [Screat] < 1.5 mg/dl)
• elevated urinary beta2-microglobulin and IgG

Immunosuppressive therapy consisting of:

• cyclophosphamide 1.5 mg/kg/day for 12 months
• prednisone orally, 0.5 mg/kg on alternate days for 6 months
• i.v. methylprednisolone 1000 mg on days 1,2,3, 60,61,62, 120,121,122

Study Groups:

• early: immediate start of immunosuppressive therapy at the time patient is identified as high-risk
• late: start of therapy after deterioration of renal function (increase of Screat > 25% and Screat > 1.5 mg/dl)

Main Outcome Parameters:

• serum creatinine
• remission of proteinuria
• period of nephrotic proteinuria
• major side effects: hospitalisations, infections

Conditions

Glomerulonephritis, Membranous

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

late intervention

cyclophosphamide and steroids started at time of renal insufficiency

Group Type: OTHER

Cyclophosphamide and steroids

Intervention Type: DRUG

comparison of difference in time of start of therapy

early intervention

immediate start of cyclophosphamide and steroids

Group Type: EXPERIMENTAL

Cyclophosphamide and steroids

Intervention Type: DRUG

comparison of difference in time of start of therapy

Interventions

Cyclophosphamide and steroids

comparison of difference in time of start of therapy

Intervention Type: DRUG

Other Intervention Names

prednisolone; endoxan

Eligibility Criteria

Inclusion Criteria

• Idiopathic membranous nephropathy
• Serum creatinine < 1.5 mg/dl
• Nephrotic syndrome

Exclusion Criteria

• Infection
• Instable angina
• Systemic disease
• Pregnancy
• Renal vein thrombosis
• Prior therapy with immunosuppressant agents
• Liver dysfunction
• Use of nonsteroidal anti-inflammatory drugs (NSAIDs)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jack F Wetzels, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

Department of Nephrology Radboud University Nijmegen Medical Centre

Nijmegen, , Netherlands

Countries

Netherlands

References

von Groote TC, Williams G, Au EH, Chen Y, Mathew AT, Hodson EM, Tunnicliffe DJ. Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2021 Nov 15;11(11):CD004293. doi: 10.1002/14651858.CD004293.pub4.

Reference Type: DERIVED

PMID: 34778952 (View on PubMed)

Hofstra JM, Branten AJ, Wirtz JJ, Noordzij TC, du Buf-Vereijken PW, Wetzels JF. Early versus late start of immunosuppressive therapy in idiopathic membranous nephropathy: a randomized controlled trial. Nephrol Dial Transplant. 2010 Jan;25(1):129-36. doi: 10.1093/ndt/gfp390. Epub 2009 Aug 8.

Reference Type: DERIVED

PMID: 19666912 (View on PubMed)

Other Identifiers

RUNMN01

Identifier Type: -

Identifier Source: org_study_id