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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00006137
First Posted: August 4, 2000
Last Update Posted: December 9, 2005
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.
Collaborator:
Stanford University
Information provided by:
Office of Rare Diseases (ORD)
  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: Primary Purpose: Treatment

Resource links provided by NLM:


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

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
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
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
Investigators
Study Chair: Bryan D. Myers Stanford University
  More Information

ClinicalTrials.gov Identifier: NCT00006137     History of Changes
Other Study ID Numbers: 199/15244
SUMC-GCRC-5R01DK49372
First Submitted: August 3, 2000
First Posted: August 4, 2000
Last Update Posted: December 9, 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
Glomerulonephritis, IGA
Nephritis
Kidney Diseases
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Enalapril
Enalaprilat
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents