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

National Center for Research Resources (NCRR)43 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

IGA Glomerulonephritis

Interventions

enalaprilDRUG

Eligibility

Sex: ALLMin age: 13 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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