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

• ClinicalTrials.gov Identifier: NCT00006137
• Recruitment Status: Completed
• First Posted: August 4, 2000
• Last Update Posted: June 24, 2005
• Sponsor: National Center for Research Resources (NCRR)
• Collaborator: Stanford University
• Information provided by: Office of Rare Diseases (ORD)

Tracking Information

• First Submitted Date: August 3, 2000
• First Posted Date: August 4, 2000
• Last Update Posted Date: June 24, 2005
• Study Start Date: May 2000
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Pilot Study of Enalapril and Renal Function in Patients With IgA Nephropathy
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Primary Purpose: Treatment
• Condition: IGA Glomerulonephritis
• Intervention: Drug: enalapril
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: June 23, 2005): 43
• Original Enrollment: Same as current
• Study Completion Date: Not Provided
• Primary Completion Date: Not Provided

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 13 Years to 60 Years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00006137
• Other Study ID Numbers: 199/15244; SUMC-GCRC-5R01DK49372
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: National Center for Research Resources (NCRR)
• Collaborators: Stanford University

Investigators

• Study Chair: Bryan D. Myers; Stanford University

• PRS Account: Office of Rare Diseases (ORD)
• Verification Date: September 2000