Pilot Study of Enalapril and Renal Function in Patients With IgA Nephropathy
Information source: Office of Rare Diseases (ORD)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: IGA Glomerulonephritis
Intervention: enalapril (Drug)
Phase: N/A
Status: Completed
Sponsored by: National Center for Research Resources (NCRR) Official(s) and/or principal investigator(s):
Bryan D. Myers, Study Chair, Affiliation: Stanford University
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.
Clinical Details
Study design: Treatment
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.
Eligibility
Minimum age: 13 Years.
Maximum age: 60 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: May 2000
Last updated: June 23, 2005
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