NCT00135954

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 1997

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1997

Completed
8.2 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

January 28, 2014

Status Verified

February 1, 2007

Enrollment Period

11 years

First QC Date

August 25, 2005

Last Update Submit

January 27, 2014

Conditions

Glomerulonephritis, Membranous

Keywords

membranous nephropathycyclophosphamideprednisone

Outcome Measures

Primary Outcomes (3)

  • renal function (serum creatinine)

  • proteinuria

  • side effects

Study Arms (2)

late intervention

OTHER

cyclophosphamide and steroids started at time of renal insufficiency

Drug: Cyclophosphamide and steroids

early intervention

EXPERIMENTAL

immediate start of cyclophosphamide and steroids

Drug: Cyclophosphamide and steroids

Interventions

Cyclophosphamide and steroidsDRUG

comparison of difference in time of start of therapy

Also known as: prednisolone, endoxan
early interventionlate intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nephrology Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 34778952DERIVED

  • 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.

    PMID: 19666912DERIVED

MeSH Terms

Conditions

Glomerulonephritis, Membranous

Interventions

CyclophosphamideSteroidsPrednisolone

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsFused-Ring CompoundsPolycyclic CompoundsPregnadienetriolsPregnadienesPregnanes

Study Officials

  • Jack F Wetzels, MD, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2005

First Posted

August 26, 2005

Study Start

July 1, 1997

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

January 28, 2014

Record last verified: 2007-02

Locations

NL(1)