IGA GlomerulonephritisNCT00006137
Pilot Study of Enalapril and Renal Function in Patients With IgA Nephropathy
A study testing enalapril in people with IGA Glomerulonephritis, run by National Center for Research Resources (NCRR).
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- IGA Glomerulonephritis
- What is being tested?
- enalapril
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- May 2000to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
About this study
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.
Read the 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.
- Conditions
- IGA Glomerulonephritis
- Being tested
- enalapril
- Keywords
- IgA glomerulonephritis, rare disease, renal and genitourinary disorders
- Medical subject headings
- Glomerulonephritis, IGA, Rare Diseases, Urogenital Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enalaprilDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2000 (estimated)
- Study startMay 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IGA GlomerulonephritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Enrolment
- 43 participants
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Stanford University
- Investigators
- Bryan D. Myers, Study chair, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006137
- Sponsor's protocol ID
- 199/15244
- Other IDs
- SUMC-GCRC-5R01DK49372
- Status last verified
- Sep 2000
- First submitted
- 3 Aug 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Enalapril and Renal Function in Patients With IgA Nephropathy
- ClinicalTrials.gov ID
- NCT00006137
- Acronym / sponsor ID
- 199/15244
- Conditions
- IGA Glomerulonephritis
- Keywords
- IgA glomerulonephritis, rare disease, renal and genitourinary disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- Collaborators
- Stanford University
- Study start
- May 2000
- First posted
- 4 Aug 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 13 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enalapril | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bryan D. Myers study chair
Stanford University
Questions about this trial
What is this clinical trial studying?
A study testing enalapril in people with IGA Glomerulonephritis, run by National Center for Research Resources (NCRR).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.