Trial Outcomes & Findings for Acthar for Treatment-Resistant or Treatment-Intolerant Proteinuria (NCT NCT02633046)
NCT ID: NCT02633046
Last Updated: 2021-08-04
Results Overview
Clinically significant changes in laboratory or physical examination findings are counted as adverse events. Descriptive statistics are collected for participants with: 1. death for any reason (all cause mortality) 2. treatment emergent serious adverse events (TESAEs) 3. any non-serious treatment emergent adverse events (TEAEs)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
63 participants
Primary outcome timeframe
within 56 weeks
Results posted on
2021-08-04
Participant Flow
Multiple locations enrolled participants in Argentina (3), Australia (5), Chile (4), Mexico (5), Peru (8), Turkey (13), and the United States (25).
Participant milestones
| Measure |
Acthar Gel
All participants receive open-label treatment with Acthar Gel per protocol regimen:
Acthar Gel, 1 mL (80 U) by subcutaneous injection (SC) 3x/week will be administered to all participants from Week 0 to 50. Tapering of dose to 1 mL SC 2x/week will be allowed for safety and/ tolerability issues. Once the dose is tapered to 1 mL SC 2x/week it must remain at this level. Participants unable to tolerate 1 mL SC 2x/week will be discontinued. All participants will have an End of Study/Early Termination Visit 4 weeks after discontinuing Investigational Medicinal Product.
|
|---|---|
|
Overall Study
STARTED
|
63
|
|
Overall Study
Safety Population
|
63
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
27
|
Reasons for withdrawal
| Measure |
Acthar Gel
All participants receive open-label treatment with Acthar Gel per protocol regimen:
Acthar Gel, 1 mL (80 U) by subcutaneous injection (SC) 3x/week will be administered to all participants from Week 0 to 50. Tapering of dose to 1 mL SC 2x/week will be allowed for safety and/ tolerability issues. Once the dose is tapered to 1 mL SC 2x/week it must remain at this level. Participants unable to tolerate 1 mL SC 2x/week will be discontinued. All participants will have an End of Study/Early Termination Visit 4 weeks after discontinuing Investigational Medicinal Product.
|
|---|---|
|
Overall Study
Adverse Event
|
8
|
|
Overall Study
Physician Decision
|
7
|
|
Overall Study
Withdrawal by Subject
|
8
|
|
Overall Study
Increased proteinuria
|
2
|
|
Overall Study
Participant decided not to continue with open label extension
|
1
|
|
Overall Study
Mutual decision patient and physician
|
1
|
Baseline Characteristics
Acthar for Treatment-Resistant or Treatment-Intolerant Proteinuria
Baseline characteristics by cohort
| Measure |
Acthar Gel
n=63 Participants
All participants receive open-label treatment with Acthar Gel per protocol regimen
|
|---|---|
|
Age, Continuous
|
36.1 years
STANDARD_DEVIATION 13.54 • n=5 Participants
|
|
Age, Customized
18-25 years of age
|
16 Participants
n=5 Participants
|
|
Age, Customized
26-45 years of age
|
29 Participants
n=5 Participants
|
|
Age, Customized
46-65 years of age
|
17 Participants
n=5 Participants
|
|
Age, Customized
greater than 65 years of age
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
13 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Chile
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Peru
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: within 56 weeksPopulation: Safety population
Clinically significant changes in laboratory or physical examination findings are counted as adverse events. Descriptive statistics are collected for participants with: 1. death for any reason (all cause mortality) 2. treatment emergent serious adverse events (TESAEs) 3. any non-serious treatment emergent adverse events (TEAEs)
Outcome measures
| Measure |
Acthar Gel
n=63 Participants
All participants receive open-label treatment with Acthar Gel per protocol regimen
|
|---|---|
|
Number of Participants With Adverse Events
Deaths
|
0 Participants
|
|
Number of Participants With Adverse Events
Serious TEAEs
|
11 Participants
|
|
Number of Participants With Adverse Events
Non-serious TEAEs
|
60 Participants
|
Adverse Events
Acthar Gel
Serious events: 11 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Acthar Gel
n=63 participants at risk
All participants receive open-label treatment with Acthar Gel per protocol regimen
|
|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
3.2%
2/63 • Number of events 2 • within 56 weeks
Treatment emergent adverse events are recorded.
|
|
General disorders
Oedema
|
1.6%
1/63 • Number of events 2 • within 56 weeks
Treatment emergent adverse events are recorded.
|
|
General disorders
Pyrexia
|
1.6%
1/63 • Number of events 1 • within 56 weeks
Treatment emergent adverse events are recorded.
|
|
Infections and infestations
Gastroenteritis
|
1.6%
1/63 • Number of events 1 • within 56 weeks
Treatment emergent adverse events are recorded.
|
|
Infections and infestations
Soft tissue infection
|
1.6%
1/63 • Number of events 2 • within 56 weeks
Treatment emergent adverse events are recorded.
|
|
Investigations
Blood creatinine increased
|
1.6%
1/63 • Number of events 1 • within 56 weeks
Treatment emergent adverse events are recorded.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.6%
1/63 • Number of events 1 • within 56 weeks
Treatment emergent adverse events are recorded.
|
|
Psychiatric disorders
Acute psychosis
|
1.6%
1/63 • Number of events 1 • within 56 weeks
Treatment emergent adverse events are recorded.
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
1.6%
1/63 • Number of events 1 • within 56 weeks
Treatment emergent adverse events are recorded.
|
|
Vascular disorders
Hypertensive urgency
|
1.6%
1/63 • Number of events 1 • within 56 weeks
Treatment emergent adverse events are recorded.
|
Other adverse events
| Measure |
Acthar Gel
n=63 participants at risk
All participants receive open-label treatment with Acthar Gel per protocol regimen
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
7.9%
5/63 • Number of events 5 • within 56 weeks
Treatment emergent adverse events are recorded.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.5%
6/63 • Number of events 6 • within 56 weeks
Treatment emergent adverse events are recorded.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.3%
4/63 • Number of events 4 • within 56 weeks
Treatment emergent adverse events are recorded.
|
|
Gastrointestinal disorders
Nausea
|
7.9%
5/63 • Number of events 5 • within 56 weeks
Treatment emergent adverse events are recorded.
|
|
Gastrointestinal disorders
Vomiting
|
6.3%
4/63 • Number of events 4 • within 56 weeks
Treatment emergent adverse events are recorded.
|
|
General disorders
Fatigue
|
7.9%
5/63 • Number of events 6 • within 56 weeks
Treatment emergent adverse events are recorded.
|
|
General disorders
Injection site bruising
|
7.9%
5/63 • Number of events 5 • within 56 weeks
Treatment emergent adverse events are recorded.
|
|
General disorders
Oedema
|
15.9%
10/63 • Number of events 13 • within 56 weeks
Treatment emergent adverse events are recorded.
|
|
General disorders
Oedema peripheral
|
7.9%
5/63 • Number of events 7 • within 56 weeks
Treatment emergent adverse events are recorded.
|
|
Infections and infestations
Nasopharyngitis
|
7.9%
5/63 • Number of events 5 • within 56 weeks
Treatment emergent adverse events are recorded.
|
|
Infections and infestations
Upper respiratory tract infection
|
22.2%
14/63 • Number of events 15 • within 56 weeks
Treatment emergent adverse events are recorded.
|
|
Investigations
Weight increased
|
7.9%
5/63 • Number of events 5 • within 56 weeks
Treatment emergent adverse events are recorded.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
15.9%
10/63 • Number of events 11 • within 56 weeks
Treatment emergent adverse events are recorded.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.3%
4/63 • Number of events 6 • within 56 weeks
Treatment emergent adverse events are recorded.
|
|
Nervous system disorders
Headache
|
9.5%
6/63 • Number of events 6 • within 56 weeks
Treatment emergent adverse events are recorded.
|
|
Psychiatric disorders
Insomnia
|
14.3%
9/63 • Number of events 9 • within 56 weeks
Treatment emergent adverse events are recorded.
|
|
Vascular disorders
Hypertension
|
15.9%
10/63 • Number of events 17 • within 56 weeks
Treatment emergent adverse events are recorded.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place