Trial Outcomes & Findings for Steroid Treatment for Kidney Disease (NCT NCT00065611)
NCT ID: NCT00065611
Last Updated: 2011-10-28
Results Overview
Complete remission is defined as proteinuria \<0.3 g/d. Partial remission is defined as a 50% fall in proteinuria compared to baseline, proteinuria \<3.5 g/d, and a preserved estimated glomerular filtration rate (eGFR), specified as \>60% of baseline. Limited response is defined as a 50% fall in proteinuria compared to baseline. All other outcomes are described as non-response.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
8 participants
Primary outcome timeframe
48 weeks from baseline
Results posted on
2011-10-28
Participant Flow
8 patients were enrolled in the study, 4 of them are randomized to 2 dose every 2 week arm and 4 of them are randomized to 4 dose every 4 week arm.
Participant milestones
| Measure |
2 Doses Every 2 Weeks Arm
Patients in this arm receive 2 doses every 2 weeks
|
4 Doses Every 4 Weeks Arm
Patients in this arm receive 4 doses every 4 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Steroid Treatment for Kidney Disease
Baseline characteristics by cohort
| Measure |
2 Doses Every 2 Weeks Arm
n=4 Participants
Patients in this arm receive 2 doses every 2 weeks
|
4 Doses Every 4 Weeks Arm
n=3 Participants
Patients in this arm receive 4 doses every 4 weeks
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
38 years
STANDARD_DEVIATION 9 • n=5 Participants
|
30 years
STANDARD_DEVIATION 5 • n=7 Participants
|
35 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Urine Protein
|
11.2 g/d
STANDARD_DEVIATION 7.0 • n=5 Participants
|
10.0 g/d
STANDARD_DEVIATION 1.9 • n=7 Participants
|
10.8 g/d
STANDARD_DEVIATION 5.1 • n=5 Participants
|
|
CKD-EPI eGFR
|
59.2 ml/min/1.73m^2
STANDARD_DEVIATION 13.4 • n=5 Participants
|
76.3 ml/min/1.73m^2
STANDARD_DEVIATION 21.4 • n=7 Participants
|
66.6 ml/min/1.73m^2
STANDARD_DEVIATION 18.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: 48 weeks from baselinePopulation: ITT
Complete remission is defined as proteinuria \<0.3 g/d. Partial remission is defined as a 50% fall in proteinuria compared to baseline, proteinuria \<3.5 g/d, and a preserved estimated glomerular filtration rate (eGFR), specified as \>60% of baseline. Limited response is defined as a 50% fall in proteinuria compared to baseline. All other outcomes are described as non-response.
Outcome measures
| Measure |
2 Doses Every 2 Weeks Arm
n=4 Participants
Patients in this arm receive 2 doses every 2 weeks
|
4 Doses Every 4 Weeks Arm
n=3 Participants
Patients in this arm receive 4 doses every 4 weeks
|
|---|---|---|
|
Remission Status of Patients After Intermittent Oral Dexamethasone Administered Over 48 Weeks
Limited response
|
1 participants
|
1 participants
|
|
Remission Status of Patients After Intermittent Oral Dexamethasone Administered Over 48 Weeks
Non-response
|
2 participants
|
1 participants
|
|
Remission Status of Patients After Intermittent Oral Dexamethasone Administered Over 48 Weeks
Partial remission
|
1 participants
|
1 participants
|
|
Remission Status of Patients After Intermittent Oral Dexamethasone Administered Over 48 Weeks
Complete remission
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 48 weeks from baselineOutcome measures
| Measure |
2 Doses Every 2 Weeks Arm
n=4 Participants
Patients in this arm receive 2 doses every 2 weeks
|
4 Doses Every 4 Weeks Arm
n=3 Participants
Patients in this arm receive 4 doses every 4 weeks
|
|---|---|---|
|
Urine Protein
|
3.6 g/d
Standard Deviation 0.7
|
6.2 g/d
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: 48 weeks from baselineEstimate glomerular filtration rate (eGFR) using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula.
Outcome measures
| Measure |
2 Doses Every 2 Weeks Arm
n=4 Participants
Patients in this arm receive 2 doses every 2 weeks
|
4 Doses Every 4 Weeks Arm
n=3 Participants
Patients in this arm receive 4 doses every 4 weeks
|
|---|---|---|
|
CKD-EPI eGFR
|
60 ml/min/1.73m^2
Standard Deviation 16
|
73 ml/min/1.73m^2
Standard Deviation 20
|
Adverse Events
2 Doses Every 2 Weeks Arm
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
4 Doses Every 4 Weeks Arm
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
2 Doses Every 2 Weeks Arm
n=4 participants at risk
Patients in this arm receive 2 doses every 2 weeks
|
4 Doses Every 4 Weeks Arm
n=4 participants at risk
Patients in this arm receive 4 doses every 4 weeks
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Tendon rupture
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
|
Gastrointestinal disorders
Acute appendicitis, increased intraocular pressure
|
0.00%
0/4
|
50.0%
2/4 • Number of events 2
|
Other adverse events
| Measure |
2 Doses Every 2 Weeks Arm
n=4 participants at risk
Patients in this arm receive 2 doses every 2 weeks
|
4 Doses Every 4 Weeks Arm
n=4 participants at risk
Patients in this arm receive 4 doses every 4 weeks
|
|---|---|---|
|
General disorders
Headache
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
|
General disorders
sleep disturbance
|
25.0%
1/4 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Mood swings
|
50.0%
2/4 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Change in appetite
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Weight gain
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Impaired glucose tolerance
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Cushingoid appearance
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle pains
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
|
Infections and infestations
Infections
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place