Treatment of Patients With Idiopathic Membranous Nephropathy

January 27, 2014 updated by: Radboud University Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Nijmegen, Netherlands, 6500 HB
        • Department of Nephrology Radboud University Nijmegen Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: late intervention
cyclophosphamide and steroids started at time of renal insufficiency
Drug: Cyclophosphamide and steroids
comparison of difference in time of start of therapy
Other Names:
  • endoxan
  • prednisolone
Experimental: early intervention
immediate start of cyclophosphamide and steroids
Drug: Cyclophosphamide and steroids
comparison of difference in time of start of therapy
Other Names:
  • endoxan
  • prednisolone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
side effects
proteinuria
renal function (serum creatinine)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: Jack F Wetzels, MD, PhD, Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1997

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

August 25, 2005

First Submitted That Met QC Criteria

August 25, 2005

First Posted (Estimate)

August 26, 2005

Study Record Updates

Last Update Posted (Estimate)

January 28, 2014

Last Update Submitted That Met QC Criteria

January 27, 2014

Last Verified

February 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RUNMN01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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