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Treatment of Patients With Idiopathic Membranous Nephropathy

Sponsor
Radboud University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00135954
Collaborator
(none)
29
Enrollment
1
Location
2
Arms
132
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Cyclophosphamide and steroids
 Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
29 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Treatment of Patients With Idiopathic Membranous Nephropathy at Risk for Renal Insufficiency: Comparison of Early Versus Late Start of Immunosuppressive Therapy
Study Start Date :
Jul 1, 1997
Actual Primary Completion Date :
Jul 1, 2008
Actual Study Completion Date :
Jul 1, 2008

Arms and Interventions

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:
  • prednisolone
  • endoxan

    		•
    Experimental: early intervention

    immediate start of cyclophosphamide and steroids

    Drug: Cyclophosphamide and steroids
    comparison of difference in time of start of therapy
    Other Names:
  • prednisolone
  • endoxan

    		•

    Outcome Measures

    Primary Outcome Measures

    1. renal function (serum creatinine) []

    2. proteinuria []

    3. side effects []

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Nephrology Radboud University Nijmegen Medical Centre Nijmegen Netherlands 6500 HB

    Sponsors and Collaborators

    • Radboud University Medical Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Radboud University Medical Center
    ClinicalTrials.gov Identifier:
    NCT00135954
    Other Study ID Numbers:
    • RUNMN01
    First Posted:
    Aug 26, 2005
    Last Update Posted:
    Jan 28, 2014
    Last Verified:
    Feb 1, 2007
    Keywords provided by Radboud University Medical Center
    membranous nephropathy
    cyclophosphamide
    prednisone
    Additional relevant MeSH terms:
    Kidney Diseases
    Glomerulonephritis
    Glomerulonephritis, Membranous
    Prednisolone
    Cyclophosphamide

    Study Results

    No Results Posted as of Jan 28, 2014