Trial Outcomes & Findings for A Prospective Study of Microalbuminuria in Untreated Boys With Alport Syndrome (NCT NCT00622544)
NCT ID: NCT00622544
Last Updated: 2018-07-20
Results Overview
number of subjects developing microalbuminuria during study period
Recruitment status
COMPLETED
Target enrollment
44 participants
Primary outcome timeframe
2007-2009
Results posted on
2018-07-20
Participant Flow
Participant milestones
| Measure |
Observational Study: no Arms - One Group
Observational study of urine albumin and protein excretion in untreated boys with X-linked Alport syndrome
|
|---|---|
|
Overall Study
STARTED
|
44
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Prospective Study of Microalbuminuria in Untreated Boys With Alport Syndrome
Baseline characteristics by cohort
| Measure |
Observational Study: no Arms - One Group
n=35 Participants
Observational study of urine albumin and protein excretion in untreated boys with Alport syndrome
|
|---|---|
|
Age, Categorical
<=18 years
|
35 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
9.9 years
STANDARD_DEVIATION 3.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2007-2009number of subjects developing microalbuminuria during study period
Outcome measures
| Measure |
Observational Study: no Arms - One Group
n=35 Participants
Boys less than 18 years of age with a confirmed diagnosis of Alport syndrome
|
|---|---|
|
Number of Subjects Developing Microalbuminuria During Study Period
|
35 Participants
|
SECONDARY outcome
Timeframe: 2007-2009number of subjects developing proteinuria during the study period
Outcome measures
| Measure |
Observational Study: no Arms - One Group
n=35 Participants
Boys less than 18 years of age with a confirmed diagnosis of Alport syndrome
|
|---|---|
|
Number of Subjects Developing Proteinuria During the Study Period
|
35 Participants
|
Adverse Events
Observational Study: no Arms - One Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place