Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006137
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-08-03
Brief Title:
Pilot Study of Enalapril and Renal Function in Patients With IgA Nephropathy
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Patients undergo renal function studies every 6-12 months for 5 years Patients undergo renal biopsy at 36-48 months after study entry
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SUMC-GCRC-5R01DK49372 | None | None | None |