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

This study has been completed.
Sponsor:
Collaborator:
Stanford University
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00006137
First received: August 3, 2000
Last updated: June 23, 2005
Last verified: September 2000

August 3, 2000
June 23, 2005
May 2000
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Complete list of historical versions of study NCT00006137 on ClinicalTrials.gov Archive Site
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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.

Interventional
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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.
 
Completed
43
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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

Both
13 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT00006137
199/15244, SUMC-GCRC-5R01DK49372
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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