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

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ClinicalTrials.gov Identifier: NCT00006137
Recruitment Status : Completed
First Posted : August 4, 2000
Last Update Posted : June 24, 2005
Stanford University
Information provided by:
Office of Rare Diseases (ORD)

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.

Condition or disease Intervention/treatment
IGA Glomerulonephritis Drug: enalapril

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Primary Purpose: Treatment
Study Start Date : May 2000

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006137

Sponsors and Collaborators
National Center for Research Resources (NCRR)
Stanford University
Study Chair: Bryan D. Myers Stanford University

ClinicalTrials.gov Identifier: NCT00006137     History of Changes
Other Study ID Numbers: 199/15244
First Posted: August 4, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: September 2000

Keywords provided by Office of Rare Diseases (ORD):
IgA glomerulonephritis
rare disease
renal and genitourinary disorders

Additional relevant MeSH terms:
Glomerulonephritis, IGA
Kidney Diseases
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents