Pilot Study of Enalapril and Renal Function in Patients With IgA Nephropathy
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ClinicalTrials.gov Identifier: NCT00006137 |
Recruitment Status
:
Completed
First Posted
: August 4, 2000
Last Update Posted
: June 24, 2005
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Tracking Information | ||||
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First Submitted Date ICMJE | August 3, 2000 | |||
First Posted Date ICMJE | August 4, 2000 | |||
Last Update Posted Date | June 24, 2005 | |||
Study Start Date ICMJE | May 2000 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures ICMJE | Not Provided | |||
Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | No Changes Posted | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Pilot Study of Enalapril and Renal Function in Patients With IgA Nephropathy | |||
Official Title ICMJE | Not Provided | |||
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. |
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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. |
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Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Primary Purpose: Treatment | |||
Condition ICMJE | IGA Glomerulonephritis | |||
Intervention ICMJE | Drug: enalapril | |||
Study Arms | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE |
43 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date | Not Provided | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | 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 |
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Sex/Gender |
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Ages | 13 Years to 60 Years (Child, Adult) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00006137 | |||
Other Study ID Numbers ICMJE | 199/15244 SUMC-GCRC-5R01DK49372 |
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Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | National Center for Research Resources (NCRR) | |||
Collaborators ICMJE | Stanford University | |||
Investigators ICMJE |
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PRS Account | Office of Rare Diseases (ORD) | |||
Verification Date | September 2000 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |