Trial Outcomes & Findings for Idiopathic Focal Segmental Glomerulosclerosis (FSGS) and Treatment With ACTH (NCT NCT01155141)
NCT ID: NCT01155141
Last Updated: 2014-09-01
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
15 participants
Primary outcome timeframe
Baseline - Month 6
Results posted on
2014-09-01
Participant Flow
Participant milestones
| Measure |
H.P. Acthar Gel
Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
H.P. Acthar Gel
Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Screen Failure
|
1
|
Baseline Characteristics
Idiopathic Focal Segmental Glomerulosclerosis (FSGS) and Treatment With ACTH
Baseline characteristics by cohort
| Measure |
H.P. Acthar Gel
n=15 Participants
Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
|
|---|---|
|
Age, Continuous
|
40 years
STANDARD_DEVIATION 15.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
24 hour proteinuria
|
3.6 g/day
STANDARD_DEVIATION 5.7 • n=5 Participants
|
|
Serum Creatinine
|
1.4 mg/dL
STANDARD_DEVIATION 0.9 • n=5 Participants
|
|
Protein/creatinine ratio
|
3.1 unitless
STANDARD_DEVIATION 2.3 • n=5 Participants
|
|
Glucose
|
95 mg/dL
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Weight
|
87.3 kg
STANDARD_DEVIATION 24.3 • n=5 Participants
|
|
Systolic blood pressure
|
128 mm Hg
STANDARD_DEVIATION 15.9 • n=5 Participants
|
|
Diastolic blood pressure
|
82 mm Hg
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Total cholesterol
|
236 mg/dL
STANDARD_DEVIATION 99.5 • n=5 Participants
|
|
eGFR
|
56 mL/min/1.73m^2
STANDARD_DEVIATION 34.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline - Month 6Outcome measures
| Measure |
H.P. Acthar Gel
n=15 Participants
Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
|
|---|---|
|
24 Hour Proteinuria
Baseline (N=15)
|
3.6 g/day
Standard Deviation 5.7
|
|
24 Hour Proteinuria
Week 5 (N=15)
|
3.8 g/day
Standard Deviation 8.6
|
|
24 Hour Proteinuria
Week 16 (N=14)
|
2.2 g/day
Standard Deviation 4.7
|
|
24 Hour Proteinuria
Month 6 (N=12)
|
3.0 g/day
Standard Deviation 3.2
|
PRIMARY outcome
Timeframe: Baseline - Month 6Outcome measures
| Measure |
H.P. Acthar Gel
n=15 Participants
Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
|
|---|---|
|
Serum Creatinine
Baseline (N=15)
|
1.4 mg/dL
Standard Deviation 0.9
|
|
Serum Creatinine
Week 5 (N=15)
|
1.8 mg/dL
Standard Deviation 0.8
|
|
Serum Creatinine
Week 9 (N=14)
|
1.8 mg/dL
Standard Deviation 1
|
|
Serum Creatinine
Week 16 (N=14)
|
1.9 mg/dL
Standard Deviation 0.9
|
|
Serum Creatinine
Month 6 (N=12)
|
2.0 mg/dL
Standard Deviation 1.1
|
PRIMARY outcome
Timeframe: Baseline - Month 6Outcome measures
| Measure |
H.P. Acthar Gel
n=15 Participants
Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
|
|---|---|
|
Protein/Creatinine Ratio
Month 6 (N=11)
|
1.6 unitless
Standard Deviation 1.3
|
|
Protein/Creatinine Ratio
Baseline (N=15)
|
3.1 unitless
Standard Deviation 2.3
|
|
Protein/Creatinine Ratio
Week 5 (N=15)
|
3.1 unitless
Standard Deviation 5.3
|
|
Protein/Creatinine Ratio
Week 16 (N=14)
|
2.4 unitless
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Baseline - Month 6Outcome measures
| Measure |
H.P. Acthar Gel
n=15 Participants
Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
|
|---|---|
|
eGFR
Baseline (N=15)
|
56.0 mL/min/1.73m^2
Standard Deviation 34.8
|
|
eGFR
Week 5 (N=15)
|
44.0 mL/min/1.73m^2
Standard Deviation 37.1
|
|
eGFR
Week 9 (N=14)
|
37.5 mL/min/1.73m^2
Standard Deviation 32.0
|
|
eGFR
Week 16 (N=14)
|
43.0 mL/min/1.73m^2
Standard Deviation 28.0
|
|
eGFR
Month 6 (n=12)
|
38.0 mL/min/1.73m^2
Standard Deviation 33.5
|
SECONDARY outcome
Timeframe: Baseline - Month 6Outcome measures
| Measure |
H.P. Acthar Gel
n=15 Participants
Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
|
|---|---|
|
Weight
Baseline (N=15)
|
87.5 kg
Standard Deviation 24.3
|
|
Weight
Week 5 (N=15)
|
89.8 kg
Standard Deviation 24.7
|
|
Weight
Week 9 (N=13)
|
94.0 kg
Standard Deviation 25.2
|
|
Weight
Week 16 (N=13)
|
93.8 kg
Standard Deviation 26.1
|
|
Weight
Month 6 (N=11)
|
91.3 kg
Standard Deviation 28.2
|
SECONDARY outcome
Timeframe: Baseline - Month 6Outcome measures
| Measure |
H.P. Acthar Gel
n=15 Participants
Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
|
|---|---|
|
Systolic Blood Pressure
Baseline (N=15)
|
128.0 mm Hg
Standard Deviation 15.9
|
|
Systolic Blood Pressure
Week 5 (N=15)
|
136.0 mm Hg
Standard Deviation 15.2
|
|
Systolic Blood Pressure
Week 9 (N=13)
|
136.0 mm Hg
Standard Deviation 18.3
|
|
Systolic Blood Pressure
Week 16 (N=14)
|
134.0 mm Hg
Standard Deviation 18.6
|
|
Systolic Blood Pressure
Month 6 (N=11)
|
128.0 mm Hg
Standard Deviation 15.6
|
SECONDARY outcome
Timeframe: Baseline - Month 6Outcome measures
| Measure |
H.P. Acthar Gel
n=15 Participants
Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
|
|---|---|
|
Diastolic Blood Pressure
Baseline (N=15)
|
82.0 mm Hg
Standard Deviation 9.8
|
|
Diastolic Blood Pressure
Week 5 (N=15)
|
85.0 mm Hg
Standard Deviation 11.1
|
|
Diastolic Blood Pressure
Week 9 (N=13)
|
80.0 mm Hg
Standard Deviation 10.1
|
|
Diastolic Blood Pressure
Week 16 (N=14)
|
78.0 mm Hg
Standard Deviation 12.1
|
|
Diastolic Blood Pressure
Month 6 (N=11)
|
77.0 mm Hg
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: Baseline - Month 6Outcome measures
| Measure |
H.P. Acthar Gel
n=15 Participants
Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
|
|---|---|
|
Glucose
Baseline (N=15)
|
95 mg/dL
Standard Deviation 8.4
|
|
Glucose
Week 5 (N=15)
|
92.0 mg/dL
Standard Deviation 14.9
|
|
Glucose
Week 9 (N=14)
|
93.0 mg/dL
Standard Deviation 24.0
|
|
Glucose
Week 16 (N=14)
|
97.0 mg/dL
Standard Deviation 17.2
|
|
Glucose
Month 6 (N=13)
|
88.0 mg/dL
Standard Deviation 14.3
|
SECONDARY outcome
Timeframe: Baseline - Month 6Outcome measures
| Measure |
H.P. Acthar Gel
n=14 Participants
Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
|
|---|---|
|
Total Cholesterol
Baseline (N=15)
|
236.0 mg/dL
Standard Deviation 99.5
|
|
Total Cholesterol
Week 5 (N=14)
|
215.0 mg/dL
Standard Deviation 86.2
|
|
Total Cholesterol
Week 16 (N=13)
|
229.0 mg/dL
Standard Deviation 90.4
|
|
Total Cholesterol
Month 6 (N=13)
|
217.0 mg/dL
Standard Deviation 133.3
|
Adverse Events
H.P. Acthar Gel
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
H.P. Acthar Gel
n=15 participants at risk
Patients were treated with 40 units subcutaneously (SC) weekly for 2 weeks, then dose increased to 80 units SC weekly for 2 weeks followed by 80 units SC twice weekly to complete 16 weeks of therapy.
|
|---|---|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.7%
1/15
|
|
Renal and urinary disorders
Acute Kidney Injury
|
6.7%
1/15
|
Other adverse events
| Measure |
H.P. Acthar Gel
n=15 participants at risk
Patients were treated with 40 units subcutaneously (SC) weekly for 2 weeks, then dose increased to 80 units SC weekly for 2 weeks followed by 80 units SC twice weekly to complete 16 weeks of therapy.
|
|---|---|
|
Vascular disorders
Elevated Blood Pressure
|
13.3%
2/15
|
|
Psychiatric disorders
Altered Mood
|
6.7%
1/15
|
|
Metabolism and nutrition disorders
Increased Energy
|
26.7%
4/15
|
|
Ear and labyrinth disorders
Vertigo
|
6.7%
1/15
|
|
Skin and subcutaneous tissue disorders
Slow Wound Healing
|
6.7%
1/15
|
|
Injury, poisoning and procedural complications
Bruising at Injection Site
|
6.7%
1/15
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15
|
|
Metabolism and nutrition disorders
Increased Appetite
|
6.7%
1/15
|
|
Infections and infestations
Cold
|
6.7%
1/15
|
|
General disorders
Fatigue
|
13.3%
2/15
|
|
Investigations
Weight Gain
|
13.3%
2/15
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramps
|
6.7%
1/15
|
|
Nervous system disorders
Headache
|
6.7%
1/15
|
|
Renal and urinary disorders
Polyuria
|
6.7%
1/15
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
1/15
|
|
General disorders
Facial Swelling
|
6.7%
1/15
|
|
General disorders
Leg Swelling
|
13.3%
2/15
|
|
Skin and subcutaneous tissue disorders
Acne
|
20.0%
3/15
|
|
Endocrine disorders
Cushingoid
|
6.7%
1/15
|
|
Renal and urinary disorders
Nephrotic Syndrome
|
6.7%
1/15
|
|
Nervous system disorders
Felt Faint after Injection
|
6.7%
1/15
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.7%
1/15
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
1/15
|
|
Eye disorders
Blurred Vision
|
6.7%
1/15
|
|
Nervous system disorders
Right Arm Numbness
|
6.7%
1/15
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place