Clinical trial NCT00135954: Treatment of Patients With Idiopathic Membranous Nephropathy
Official title: Treatment of Patients With Idiopathic Membranous Nephropathy at Risk for Renal Insufficiency: Comparison of Early Versus Late Start of Immunosuppressive Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glomerulonephritis, Membranous
Keywords: membranous nephropathy
cyclophosphamide
prednisone
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2005-08-26
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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)

Primary outcomes:
measure: renal function (serum creatinine)
measure: proteinuria
measure: side effects
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Department of Nephrology Radboud University Nijmegen Medical Centre
Study officials:
affiliation: Radboud University Medical Center
name: Jack F Wetzels, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.