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Treatment of Patients With Idiopathic Membranous Nephropathy

Treatment of Patients With Idiopathic Membranous Nephropathy at Risk for Renal Insufficiency: Comparison of Early Versus Late Start of Immunosuppressive Therapy

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00135954
Enrollment
29
Registered
2005-08-26
Start date
1997-07-31
Completion date
2008-07-31
Last updated
2014-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glomerulonephritis, Membranous

Keywords

membranous nephropathy, cyclophosphamide, prednisone

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

Interventions

DRUGCyclophosphamide and steroids

comparison of difference in time of start of therapy

Sponsors

Radboud University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
renal function (serum creatinine)
proteinuria
side effects

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026