Trial Outcomes & Findings for Adrenocorticotropic Hormone (ACTH) for Frequently Relapsing and Steroid Dependent Nephrotic Syndrome (NCT NCT02132195)

NCT ID: NCT02132195

Last Updated: 2019-05-29

Results Overview

Number of participants experienced a relapse of nephrotic syndrome during the initial 6 months of the study.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

31 participants

Primary outcome timeframe

6 months

Results posted on

2019-05-29

Participant Flow

Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.

Participant milestones

Participant milestones
Measure	Adrenocorticotropic Hormone (ACTH) Patients will receive ACTH twice weekly subcutaneously The initial dosing will be based on body surface area (BSA): 80 IU/1.73 m2 The patients will receive the initial dose for 6 months. At 6 months, the dose will be reduced by 50%. Patients who have side effects may have the dose reduced by 50% during the initial 6 months. A second dose reduction would still occur at 6 months (25% of initial dose). ACTH: Patients will receive ACTH twice weekly for 6 months, with a 50% dose reduction allowed for side effects. The dose will be reduce by 50% at 6 months and continued for an additional 6 months.	No Treatment Patients in this treatment arm will receive no treatment to prevent relapses of nephrotic syndrome. A relapse, if it occurs, will be treated with prednisone and the patient will leave the no treatment arm of the study. There is an option for the patient to elect to be placed in the active treatment arm of the trial (rescue therapy).	Rescue Therapy Patients moved from No-treatment group to receive rescue ACTH therapy twice weekly for 6 months, with a 50% dose reduction allowed for side effects. The dose will be reduce by 50% at 6 months and continued for an additional 6 months. Other Names: Acthar Adrenocorticotropic hormone
Initial Assignment STARTED	15	16	0
Initial Assignment COMPLETED	1	16	0
Initial Assignment NOT COMPLETED	14	0	0
Rescue Therapy STARTED	0	0	13
Rescue Therapy COMPLETED	0	0	2
Rescue Therapy NOT COMPLETED	0	0	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Adrenocorticotropic Hormone (ACTH) Patients will receive ACTH twice weekly subcutaneously The initial dosing will be based on body surface area (BSA): 80 IU/1.73 m2 The patients will receive the initial dose for 6 months. At 6 months, the dose will be reduced by 50%. Patients who have side effects may have the dose reduced by 50% during the initial 6 months. A second dose reduction would still occur at 6 months (25% of initial dose). ACTH: Patients will receive ACTH twice weekly for 6 months, with a 50% dose reduction allowed for side effects. The dose will be reduce by 50% at 6 months and continued for an additional 6 months.	Rescue Therapy Patients moved from No-treatment group to receive rescue ACTH therapy twice weekly for 6 months, with a 50% dose reduction allowed for side effects. The dose will be reduce by 50% at 6 months and continued for an additional 6 months. Other Names: Acthar Adrenocorticotropic hormone
Initial Assignment Relapsed	14	0
Rescue Therapy Relapsed	0	7
Rescue Therapy Physician Decision	0	1
Rescue Therapy Withdrawal by Subject	0	1
Rescue Therapy Adverse Event	0	2

Baseline Characteristics

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 6 months

Population: The primary outcome measure was accessed during the initial 6 months based on initial assignment, rescue therapy group was not part of the analysis.

Number of participants experienced a relapse of nephrotic syndrome during the initial 6 months of the study.

Outcome measures

Outcome measures
Measure	Adrenocorticotropic Hormone (ACTH) n=15 Participants Patients will receive ACTH twice weekly subcutaneously The initial dosing will be based on body surface area (BSA): 80 IU/1.73 m2 The patients will receive the initial dose for 6 months. At 6 months, the dose will be reduced by 50%. Patients who have side effects may have the dose reduced by 50% during the initial 6 months. A second dose reduction would still occur at 6 months (25% of initial dose). ACTH: Patients will receive ACTH twice weekly for 6 months, with a 50% dose reduction allowed for side effects. The dose will be reduce by 50% at 6 months and continued for an additional 6 months.	No Treatment n=16 Participants Patients in this treatment arm will receive no treatment to prevent relapses of nephrotic syndrome. A relapse, if it occurs, will be treated with prednisone and the patient will leave the no treatment arm of the study. There is an option for the patient to elect to be placed in the active treatment arm of the trial (rescue therapy).	Rescue Therapy Patients moved from No-treatment group to receive rescue ACTH therapy twice weekly for 6 months, with a 50% dose reduction allowed for side effects. The dose will be reduce by 50% at 6 months and continued for an additional 6 months. Other Names: Acthar Adrenocorticotropic hormon
Number of Participants Experienced a Relapse of Nephrotic Syndrome	14 Participants	15 Participants	—

SECONDARY outcome

Timeframe: 6 to 12 months

Population: Three participants who completed 6 months of ACTH Full Dose therapy and then 6 months of Reduced Dose ACTH - inclusive of one subject initially randomized to ACTH and two subjects who received ACTH as rescue treatment

The dose of ACTH will be reduced by 50% after 6 months and the rate of relapse during this period will be evaluated.

Outcome measures

Outcome measures
Measure	Adrenocorticotropic Hormone (ACTH) n=1 Participants Patients will receive ACTH twice weekly subcutaneously The initial dosing will be based on body surface area (BSA): 80 IU/1.73 m2 The patients will receive the initial dose for 6 months. At 6 months, the dose will be reduced by 50%. Patients who have side effects may have the dose reduced by 50% during the initial 6 months. A second dose reduction would still occur at 6 months (25% of initial dose). ACTH: Patients will receive ACTH twice weekly for 6 months, with a 50% dose reduction allowed for side effects. The dose will be reduce by 50% at 6 months and continued for an additional 6 months.	No Treatment Patients in this treatment arm will receive no treatment to prevent relapses of nephrotic syndrome. A relapse, if it occurs, will be treated with prednisone and the patient will leave the no treatment arm of the study. There is an option for the patient to elect to be placed in the active treatment arm of the trial (rescue therapy).	Rescue Therapy n=2 Participants Patients moved from No-treatment group to receive rescue ACTH therapy twice weekly for 6 months, with a 50% dose reduction allowed for side effects. The dose will be reduce by 50% at 6 months and continued for an additional 6 months. Other Names: Acthar Adrenocorticotropic hormon
Number of Participants Experiencing Relapses After Dose Reduction of ACTH	0 Participants	—	0 Participants

SECONDARY outcome

Timeframe: 12 months

Population: 15 pts randomized to receive ACTH, and 16 pts randomized to No-treatment. 13 patients in No-treatment arm elected to receive ACTH as rescue therapy.

Adverse events will be collected (SAEs and AEs)

Outcome measures

Outcome measures
Measure	Adrenocorticotropic Hormone (ACTH) n=15 Participants Patients will receive ACTH twice weekly subcutaneously The initial dosing will be based on body surface area (BSA): 80 IU/1.73 m2 The patients will receive the initial dose for 6 months. At 6 months, the dose will be reduced by 50%. Patients who have side effects may have the dose reduced by 50% during the initial 6 months. A second dose reduction would still occur at 6 months (25% of initial dose). ACTH: Patients will receive ACTH twice weekly for 6 months, with a 50% dose reduction allowed for side effects. The dose will be reduce by 50% at 6 months and continued for an additional 6 months.	No Treatment n=16 Participants Patients in this treatment arm will receive no treatment to prevent relapses of nephrotic syndrome. A relapse, if it occurs, will be treated with prednisone and the patient will leave the no treatment arm of the study. There is an option for the patient to elect to be placed in the active treatment arm of the trial (rescue therapy).	Rescue Therapy n=13 Participants Patients moved from No-treatment group to receive rescue ACTH therapy twice weekly for 6 months, with a 50% dose reduction allowed for side effects. The dose will be reduce by 50% at 6 months and continued for an additional 6 months. Other Names: Acthar Adrenocorticotropic hormon
Number of Adverse Events	12 number of events	4 number of events	17 number of events

Adverse Events

Adrenocorticotropic Hormone (ACTH)

Serious events: 3 serious events

Other events: 4 other events

Deaths: 0 deaths

No Treatment

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Rescue Therapy

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Adrenocorticotropic Hormone (ACTH) n=15 participants at risk Patients will receive ACTH twice weekly subcutaneously The initial dosing will be based on body surface area (BSA): 80 IU/1.73 m2 The patients will receive the initial dose for 6 months. At 6 months, the dose will be reduced by 50%. Patients who have side effects may have the dose reduced by 50% during the initial 6 months. A second dose reduction would still occur at 6 months (25% of initial dose). ACTH: Patients will receive ACTH twice weekly for 6 months, with a 50% dose reduction allowed for side effects. The dose will be reduce by 50% at 6 months and continued for an additional 6 months.	No Treatment n=16 participants at risk Patients in this treatment arm will receive no treatment to prevent relapses of nephrotic syndrome. A relapse, if it occurs, will be treated with prednisone and the patient will leave the no treatment arm of the study.	Rescue Therapy n=13 participants at risk Patients moved from No-treatment group to receive rescue ACTH therapy twice weekly for 6 months, with a 50% dose reduction allowed for side effects. The dose will be reduce by 50% at 6 months and continued for an additional 6 months. Other Names: Acthar Adrenocorticotropic hormon
General disorders Hospitalization for renal disease relapse affecting multiple systems	20.0% 3/15 • Number of events 5 • 1 year	12.5% 2/16 • Number of events 2 • 1 year	15.4% 2/13 • Number of events 2 • 1 year

Other adverse events

Other adverse events
Measure	Adrenocorticotropic Hormone (ACTH) n=15 participants at risk Patients will receive ACTH twice weekly subcutaneously The initial dosing will be based on body surface area (BSA): 80 IU/1.73 m2 The patients will receive the initial dose for 6 months. At 6 months, the dose will be reduced by 50%. Patients who have side effects may have the dose reduced by 50% during the initial 6 months. A second dose reduction would still occur at 6 months (25% of initial dose). ACTH: Patients will receive ACTH twice weekly for 6 months, with a 50% dose reduction allowed for side effects. The dose will be reduce by 50% at 6 months and continued for an additional 6 months.	No Treatment n=16 participants at risk Patients in this treatment arm will receive no treatment to prevent relapses of nephrotic syndrome. A relapse, if it occurs, will be treated with prednisone and the patient will leave the no treatment arm of the study.	Rescue Therapy n=13 participants at risk Patients moved from No-treatment group to receive rescue ACTH therapy twice weekly for 6 months, with a 50% dose reduction allowed for side effects. The dose will be reduce by 50% at 6 months and continued for an additional 6 months. Other Names: Acthar Adrenocorticotropic hormon
Infections and infestations Flu and strep infections	0.00% 0/15 • 1 year	0.00% 0/16 • 1 year	23.1% 3/13 • Number of events 3 • 1 year
Social circumstances Behavioral changes	13.3% 2/15 • Number of events 2 • 1 year	0.00% 0/16 • 1 year	7.7% 1/13 • Number of events 1 • 1 year
Nervous system disorders Sleep disturbances	13.3% 2/15 • Number of events 2 • 1 year	0.00% 0/16 • 1 year	15.4% 2/13 • Number of events 2 • 1 year
Vascular disorders Increase in blood pressure	6.7% 1/15 • Number of events 2 • 1 year	0.00% 0/16 • 1 year	0.00% 0/13 • 1 year
Endocrine disorders Increase in Cushingoid symptoms	0.00% 0/15 • 1 year	6.2% 1/16 • Number of events 1 • 1 year	23.1% 3/13 • Number of events 4 • 1 year
Injury, poisoning and procedural complications Swelling, redness, rash at injection site	6.7% 1/15 • Number of events 1 • 1 year	0.00% 0/16 • 1 year	30.8% 4/13 • Number of events 5 • 1 year
Infections and infestations Rash under arms	0.00% 0/15 • 1 year	6.2% 1/16 • Number of events 1 • 1 year	0.00% 0/13 • 1 year

Additional Information

Dr. Greenbaum

Emory University

Phone: 404-712-6374

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Adrenocorticotropic Hormone (ACTH) n=15 Participants Patients will receive ACTH twice weekly subcutaneously The initial dosing will be based on body surface area (BSA): 80 IU/1.73 m2 The patients will receive the initial dose for 6 months. At 6 months, the dose will be reduced by 50%. Patients who have side effects may have the dose reduced by 50% during the initial 6 months. A second dose reduction would still occur at 6 months (25% of initial dose). ACTH: Patients will receive ACTH twice weekly for 6 months, with a 50% dose reduction allowed for side effects. The dose will be reduce by 50% at 6 months and continued for an additional 6 months.	No Treatment n=16 Participants Patients in this treatment arm will receive no treatment to prevent relapses of nephrotic syndrome. A relapse, if it occurs, will be treated with prednisone and the patient will leave the no treatment arm of the study. There is an option for the patient to elect to be placed in the active treatment arm of the trial (rescue therapy).	Rescue Therapy n=13 Participants There is an option for the patient in no-treatment arm to elect to be placed in the active treatment arm of the trial (rescue therapy).	Total n=44 Participants Total of all reporting groups
Age, Continuous Initial assignment	7.0 years n=15 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.	9.5 years n=16 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.	—	8.6 years n=31 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.
Age, Continuous Rescue therapy	—	—	9.15 years n=13 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.	9.15 years n=13 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.
Sex: Female, Male Initial assignment · Female	5 Participants n=15 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.	4 Participants n=16 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.	0 Participants Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.	9 Participants n=31 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.
Sex: Female, Male Initial assignment · Male	10 Participants n=15 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.	12 Participants n=16 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.	0 Participants Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.	22 Participants n=31 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.
Sex: Female, Male Rescue therapy · Female	—	—	3 Participants n=13 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.	3 Participants n=13 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.
Sex: Female, Male Rescue therapy · Male	—	—	10 Participants n=13 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.	10 Participants n=13 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.
Race (NIH/OMB) Initial assignment · American Indian or Alaska Native	0 Participants n=15 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.	0 Participants n=16 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.	—	0 Participants n=31 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.
Race (NIH/OMB) Initial assignment · Asian	0 Participants n=15 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.	1 Participants n=16 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.	—	1 Participants n=31 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.
Race (NIH/OMB) Initial assignment · Native Hawaiian or Other Pacific Islander	0 Participants n=15 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.	0 Participants n=16 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.	—	0 Participants n=31 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.
Race (NIH/OMB) Initial assignment · Black or African American	2 Participants n=15 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.	1 Participants n=16 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.	—	3 Participants n=31 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.
Race (NIH/OMB) Initial assignment · White	13 Participants n=15 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.	13 Participants n=16 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.	—	26 Participants n=31 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.
Race (NIH/OMB) Initial assignment · More than one race	0 Participants n=15 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.	0 Participants n=16 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.	—	0 Participants n=31 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.
Race (NIH/OMB) Initial assignment · Unknown or Not Reported	0 Participants n=15 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.	1 Participants n=16 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.	—	1 Participants n=31 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.
Race (NIH/OMB) Rescue therapy · American Indian or Alaska Native	—	—	0 Participants n=13 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.	0 Participants n=13 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.
Race (NIH/OMB) Rescue therapy · Asian	—	—	1 Participants n=13 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.	1 Participants n=13 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.
Race (NIH/OMB) Rescue therapy · Native Hawaiian or Other Pacific Islander	—	—	0 Participants n=13 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.	0 Participants n=13 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.
Race (NIH/OMB) Rescue therapy · Black or African American	—	—	0 Participants n=13 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.	0 Participants n=13 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.
Race (NIH/OMB) Rescue therapy · White	—	—	12 Participants n=13 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.	12 Participants n=13 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.
Race (NIH/OMB) Rescue therapy · More than one race	—	—	0 Participants n=13 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.	0 Participants n=13 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.
Race (NIH/OMB) Rescue therapy · Unknown or Not Reported	—	—	0 Participants n=13 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.	0 Participants n=13 Participants • Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.
Region of Enrollment United States · Initial assignment	15 Participants n=15 Participants	16 Participants n=16 Participants	0 Participants n=13 Participants	31 Participants n=44 Participants
Region of Enrollment United States · Rescue therapy	0 Participants n=15 Participants	0 Participants n=16 Participants	13 Participants n=13 Participants	13 Participants n=44 Participants