NCT00006137

Brief Summary

OBJECTIVES: I. Determine the most sensitive outcome measures (functional or morphological) of a progressive renal injury in patients with IgA nephropathy. II. Determine which of these patients are destined to progress to further injury in order to target them for therapy. III. Elucidate the determinants of progression in those patients who exhibit evidence of either increasing impairment of ultrafiltration capacity or ongoing destruction of nephrons.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2000

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2000

Completed
Last Updated

June 24, 2005

Status Verified

September 1, 2000

First QC Date

August 3, 2000

Last Update Submit

June 23, 2005

Conditions

Keywords

IgA glomerulonephritisrare diseaserenal and genitourinary disorders

Interventions

Eligibility Criteria

Age13 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Histologically confirmed IgA nephropathy, diagnosed within the past 3 years Clinical presentation of either isolated hematuria/proteinuria for less than 3 years OR Acute nephritic or nephrotic syndrome No secondary forms of IgA nephropathy associated with chronic inflammatory disease of the bowel and liver No end stage renal failure as defined by the following: Glomerular filtration rate less than 15 mL/min AND Extensive glomerulosclerosis and tubulointerstitial damage No systemic lupus erythematosus or systemic (extrarenal) vasculitis (Henoch-Schonlein syndrome) Healthy volunteers will be accrued as a control group No other concurrent medical or psychiatric illness that would preclude study

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Glomerulonephritis, IGARare DiseasesUrogenital Diseases

Interventions

Enalapril

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsMale Urogenital DiseasesAutoimmune DiseasesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DipeptidesOligopeptidesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Bryan D. Myers

    Stanford University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

August 3, 2000

First Posted

August 4, 2000

Study Start

May 1, 2000

Last Updated

June 24, 2005

Record last verified: 2000-09