Trial Outcomes & Findings for Use of Acthar in Patients With FSGS That Will be Undergoing Renal Transplantation (NCT NCT02683889)
NCT ID: NCT02683889
Last Updated: 2026-03-23
Results Overview
This will be studied in the renal transplant biopsies
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
15 participants
Primary outcome timeframe
2 years
Results posted on
2026-03-23
Participant Flow
Participant milestones
| Measure |
One Arm
One arm will receive acthar to measure rate of recurrence of FSGS after transplant. There are no other arms. We do have previous data that FSGS recurs in 23% of kidney transplants.
Acthar: patients will receive acthar 80 units twice a week for 6 months and will measure recurrence of FSGS
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Acthar in Patients With FSGS That Will be Undergoing Renal Transplantation
Baseline characteristics by cohort
| Measure |
One Arm
n=15 Participants
One arm will receive acthar to measure rate of recurrence of FSGS after transplant. There are no other arms. We do have previous data that FSGS recurs in 23% of kidney transplants.
Acthar: patients will receive acthar 80 units twice a week for 6 months and will measure recurrence of FSGS.
A total of 15 subjects where enrolled.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=10 Participants
|
|
Age, Continuous
|
43.36 Years
n=10 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 2 yearsThis will be studied in the renal transplant biopsies
Outcome measures
| Measure |
One Arm
n=15 Participants
One arm will receive acthar to measure rate of recurrence of FSGS after transplant. There are no other arms. We do have previous data that FSGS recurs in 23% of kidney transplants.
Acthar: patients will receive acthar 80 units twice a week for 6 months and will measure recurrence of FSGS
|
|---|---|
|
Rate of Recurrence of FSGS as Seen in Renal Transplant Biopsies Proteinuria
|
14 Participants
|
PRIMARY outcome
Timeframe: 2 yearsBy measurement of urine protein and urine creatinine ratio
Outcome measures
| Measure |
One Arm
n=14 Participants
One arm will receive acthar to measure rate of recurrence of FSGS after transplant. There are no other arms. We do have previous data that FSGS recurs in 23% of kidney transplants.
Acthar: patients will receive acthar 80 units twice a week for 6 months and will measure recurrence of FSGS
|
|---|---|
|
Rate of Recurrence of Proteinuria
|
3 Participants
|
SECONDARY outcome
Timeframe: 1 yearBy measurement of the estimated glomerular filtration rate with patient's creatinine
Outcome measures
Outcome data not reported
Adverse Events
One Arm
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
One Arm
n=15 participants at risk
One arm will receive acthar to measure rate of recurrence of FSGS after transplant. There are no other arms. We do have previous data that FSGS recurs in 23% of kidney transplants.
Acthar: patients will receive acthar 80 units twice a week for 6 months and will measure recurrence of FSGS
|
|---|---|
|
Endocrine disorders
Severe hypoglycemia
|
6.7%
1/15 • Number of events 1 • 30 months
|
Other adverse events
| Measure |
One Arm
n=15 participants at risk
One arm will receive acthar to measure rate of recurrence of FSGS after transplant. There are no other arms. We do have previous data that FSGS recurs in 23% of kidney transplants.
Acthar: patients will receive acthar 80 units twice a week for 6 months and will measure recurrence of FSGS
|
|---|---|
|
Renal and urinary disorders
Anuria
|
6.7%
1/15 • Number of events 1 • 30 months
|
|
Renal and urinary disorders
Acute Renal Failure
|
6.7%
1/15 • Number of events 1 • 30 months
|
|
Nervous system disorders
Neuropathy
|
6.7%
1/15 • Number of events 1 • 30 months
|
|
Renal and urinary disorders
Delayed Graft Function
|
6.7%
1/15 • Number of events 1 • 30 months
|
|
Infections and infestations
CMV Viremia
|
6.7%
1/15 • Number of events 1 • 30 months
|
|
Cardiac disorders
Atrial Fibrillation
|
6.7%
1/15 • Number of events 1 • 30 months
|
Additional Information
Assistant Director of Transplant Clinical Research
University of Colorado Denver Anschutz Medical Campus
Phone: 3037246446
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place