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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 3, 2000 | ||||
| Last Updated Date | June 23, 2005 | ||||
| Start Date ICMJE | May 2000 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00006137 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Pilot Study of Enalapril and Renal Function in Patients With IgA Nephropathy | ||||
| Official Title ICMJE | |||||
| 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 Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | IGA Glomerulonephritis | ||||
| Intervention ICMJE | Drug: enalapril | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 43 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| 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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| Gender | Both | ||||
| Ages | 13 Years to 60 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00006137 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 199/15244, SUMC-GCRC-5R01DK49372 | ||||
| Study Sponsor ICMJE | National Center for Research Resources (NCRR) | ||||
| Collaborators ICMJE | Stanford University | ||||
| Investigators ICMJE |
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| Information Provided By | Office of Rare Diseases (ORD) | ||||
| Verification Date | September 2000 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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