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

This study has been completed.

First Received: August 3, 2000 Last Updated: June 23, 2005 History of Changes

Sponsor:	National Center for Research Resources (NCRR)
Collaborator:	Stanford University
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00006137

Purpose

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	Intervention
IGA Glomerulonephritis	Drug: enalapril

Study Type:	Interventional
Study Design:	Treatment

Resource links provided by NLM:

Drug Information available for: Enalapril Enalapril maleate Enalaprilat

U.S. FDA Resources

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	43
Study Start Date:	May 2000

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

Ages Eligible for Study:	13 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006137

Sponsors and Collaborators

National Center for Research Resources (NCRR)

Stanford University

Investigators

Study Chair:

Bryan D. Myers

Stanford University

More Information

No publications provided

Study ID Numbers:	199/15244, SUMC-GCRC-5R01DK49372
Study First Received:	August 3, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00006137 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

IgA glomerulonephritis
rare disease
renal and genitourinary disorders

Additional relevant MeSH terms:

Glomerulonephritis
Autoimmune Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors

Enalapril
Urologic Diseases
Enalaprilat
Therapeutic Uses
Nephritis
Glomerulonephritis, IGA
Angiotensin-Converting Enzyme Inhibitors
Kidney Diseases

ClinicalTrials.gov processed this record on November 27, 2009