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| Sponsors and Collaborators: |
National Center for Research Resources (NCRR) 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 |
| ChemIDplus related topics: | Enalapril Enalapril maleate Enalaprilat |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Estimated Enrollment: | 43 |
| Study Start Date: | May 2000 |
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 |
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| National Center for Research Resources (NCRR) |
| Stanford University |
| Study Chair: | Bryan D. Myers | Stanford University |
More Information
| Study ID Numbers: | 199/15244, SUMC-GCRC-5R01DK49372 |
| First Received: | August 3, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00006137 |
| Health Authority: | United States: Federal Government |
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