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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00006137
Recruitment Status : Completed
First Posted : August 4, 2000
Last Update Posted : June 24, 2005
Information provided by:

August 3, 2000
August 4, 2000
June 24, 2005
May 2000
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No Changes Posted
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Pilot Study of Enalapril and Renal Function in Patients With IgA Nephropathy
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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.

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Primary Purpose: Treatment
IGA Glomerulonephritis
Drug: enalapril
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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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

Sexes Eligible for Study: All
13 Years to 60 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
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National Center for Research Resources (NCRR)
Stanford University
Study Chair: Bryan D. Myers Stanford University
Office of Rare Diseases (ORD)
September 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP