Trial Outcomes & Findings for Pilot Study of ACTH in the Treatment of Immunoglobulin A (IgA) Nephropathy at High Risk of Progression (NCT NCT02282930)

Last Updated: 2019-06-26

Results Overview

A complete response is defined by \<300 mg proteinuria/24 hours and no greater than a 10% reduction in glomerular filtration rate (GFR) as determined by quantified creatinine clearance. A partial response is defined by \>50% reduction in 24 hour proteinuria and no greater than a 25% reduction in baseline GFR as quantified creatinine clearance. No response is defined by \< or equal to 50% reduction, unchanged or increasing proteinuria over baseline levels and a greater than a 25% reduction in baseline GFR as quantified creatinine clearance.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

20 participants

Primary outcome timeframe

12 Months

Results posted on

2019-06-26

Participant Flow

Participant milestones

Participant milestones
Measure	Acthar (ACTH) Gel Injected does of 80 units subcutaneously twice weekly for 6 months. Acthar (ACTH) Gel: Injected dose of 80 units subcutaneously twice weekly for 6 months.
Overall Study STARTED	20
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study of ACTH in the Treatment of Immunoglobulin A (IgA) Nephropathy at High Risk of Progression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ACTH Gel n=19 Participants Injected does of 80 units subcutaneously twice weekly for 6 months. ACTH (Acthar) Gel: Injected dose of 80 units subcutaneously twice weekly for 6 months.
Age, Continuous	34.5 years STANDARD_DEVIATION 10.5 • n=39 Participants
Sex: Female, Male Female	8 Participants n=39 Participants
Sex: Female, Male Male	11 Participants n=39 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants
Race (NIH/OMB) Asian	5 Participants n=39 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants
Race (NIH/OMB) Black or African American	0 Participants n=39 Participants
Race (NIH/OMB) White	14 Participants n=39 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants
Region of Enrollment United States	19 participants n=39 Participants

PRIMARY outcome

Timeframe: 12 Months

Outcome measures

Outcome measures
Measure	Acthar (ACTH) Gel n=19 Participants Injected does of 80 units subcutaneously twice weekly for 6 months. ACTH (Acthar) Gel: Injected dose of 80 units subcutaneously twice weekly for 6 months.
Number of Subjects With a Complete or Partial Response to Treatment	8 Participants

SECONDARY outcome

Timeframe: 12 months

The number of subjects with infections was defined as the development of pneumonia or complicated urinary tract infection/Pyelonephritis

Outcome measures

Outcome measures
Measure	Acthar (ACTH) Gel n=19 Participants Injected does of 80 units subcutaneously twice weekly for 6 months. ACTH (Acthar) Gel: Injected dose of 80 units subcutaneously twice weekly for 6 months.
Number of Subjects to Develop an Infection	1 Participants

Adverse Events

ACTH Gel

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	ACTH Gel n=19 participants at risk Injected does of 80 units subcutaneously twice weekly for 6 months. ACTH (Acthar) Gel: Injected dose of 80 units subcutaneously twice weekly for 6 months.
Infections and infestations Infection	31.6% 6/19 • Number of events 6 • Adverse events will be collected from baseline until the completion of the final study visit for each subject, approximately 12 months.
General disorders Acne	5.3% 1/19 • Number of events 1 • Adverse events will be collected from baseline until the completion of the final study visit for each subject, approximately 12 months.
General disorders Hot flashes	5.3% 1/19 • Number of events 1 • Adverse events will be collected from baseline until the completion of the final study visit for each subject, approximately 12 months.
General disorders Soreness	5.3% 1/19 • Number of events 1 • Adverse events will be collected from baseline until the completion of the final study visit for each subject, approximately 12 months.
General disorders Anxiety	5.3% 1/19 • Number of events 1 • Adverse events will be collected from baseline until the completion of the final study visit for each subject, approximately 12 months.

Additional Information

Dr. Fernando Fervenza

Mayo Clinic

Phone: 507-266-1045

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place