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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

enalapril

About this trial

This is an interventional treatment trial for IGA Glomerulonephritis focused on measuring IgA glomerulonephritis, rare disease, renal and genitourinary disorders

Eligibility Criteria

13 Years - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00006137

First Posted

August 3, 2000

Last Updated

June 23, 2005

Sponsor

National Center for Research Resources (NCRR)

Collaborators

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT00006137

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2000

Overall Recruitment Status

Completed

Study Start Date

May 2000 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

National Center for Research Resources (NCRR)

Collaborators

Stanford University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

IGA Glomerulonephritis

Keywords

IgA glomerulonephritis, rare disease, renal and genitourinary disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Enrollment

43 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

enalapril

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bryan D. Myers

Organizational Affiliation

Stanford University

Official's Role

Study Chair

IGA Glomerulonephritis

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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