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Pilot Study of Enalapril and Renal Function in Patients With IgA Nephropathy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00006137
Enrollment
43
Registered
2000-08-04
Start date
2000-05-31
Completion date
Unknown
Last updated
2005-06-24

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

Conditions

IGA Glomerulonephritis

Keywords

IgA glomerulonephritis, rare disease, renal and genitourinary disorders

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.

Detailed description

PROTOCOL OUTLINE: Patients receive oral enalapril daily. Treatment continues for 5 years in the absence of unacceptable toxicity. Patients undergo renal function studies every 6-12 months for 5 years. Patients undergo renal biopsy at 36-48 months after study entry.

Interventions

DRUGenalapril

Sponsors

Stanford University
CollaboratorOTHER
National Center for Research Resources (NCRR)
Lead SponsorNIH

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
13 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

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

Outcome results

None listed

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