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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00006137
Recruitment Status : Completed
First Posted : August 4, 2000
Last Update Posted : June 24, 2005
Sponsor:
Collaborator:
Stanford University
Information provided by:
Office of Rare Diseases (ORD)

Tracking Information
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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE IGA Glomerulonephritis
Intervention  ICMJE Drug: enalapril
Study Arms  ICMJE 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
43
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE 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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE 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
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Center for Research Resources (NCRR)
Collaborators  ICMJE Stanford University
Investigators  ICMJE
Study Chair: Bryan D. Myers Stanford University
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