Trial Outcomes & Findings for Acthar as Rescue Therapy for Transplant Glomerulopathy in Kidney Transplant Recipients (NCT NCT02057523)

NCT ID: NCT02057523

Last Updated: 2020-09-04

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 2 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2020-09-04

Participant Flow

Participant milestones

Measure	Acthar Acthar 80 units twice weekly for 6 months. If endpoint is not reached, duration may be increased to 12 months. Acthar: Those interested will be started on Acthar 80 units twice weekly for 6 months. Those with minor adverse effects such as weight gain, worsening hypertension, or glucose intolerance will have their doses reduced to 40 unit twice weekly. Those with major adverse effects such as allergy or infection will discontinue the medication. If the primary endpoint of 50% reduction in proteinuria or total proteinuria less than 150mg/day is not reached, therapy may be continued for a total of 12 months.
Overall Study STARTED	2
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Acthar Acthar 80 units twice weekly for 6 months. If endpoint is not reached, duration may be increased to 12 months. Acthar: Those interested will be started on Acthar 80 units twice weekly for 6 months. Those with minor adverse effects such as weight gain, worsening hypertension, or glucose intolerance will have their doses reduced to 40 unit twice weekly. Those with major adverse effects such as allergy or infection will discontinue the medication. If the primary endpoint of 50% reduction in proteinuria or total proteinuria less than 150mg/day is not reached, therapy may be continued for a total of 12 months.
Overall Study Withdrawal by Subject	1
Overall Study Lack of Efficacy	1

Baseline Characteristics

Acthar as Rescue Therapy for Transplant Glomerulopathy in Kidney Transplant Recipients

Baseline characteristics by cohort

Measure	Acthar n=2 Participants Acthar 80 units twice weekly for 6 months. If endpoint is not reached, duration may be increased to 12 months. Acthar: Those interested will be started on Acthar 80 units twice weekly for 6 months. Those with minor adverse effects such as weight gain, worsening hypertension, or glucose intolerance will have their doses reduced to 40 unit twice weekly. Those with major adverse effects such as allergy or infection will discontinue the medication. If the primary endpoint of 50% reduction in proteinuria or total proteinuria less than 150mg/day is not reached, therapy may be continued for a total of 12 months.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	2 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Measure

Acthar n=1 Participants Acthar 80 units twice weekly for 6 months. If endpoint is not reached, duration may be increased to 12 months. Acthar: Those interested will be started on Acthar 80 units twice weekly for 6 months. Those with minor adverse effects such as weight gain, worsening hypertension, or glucose intolerance will have their doses reduced to 40 unit twice weekly. Those with major adverse effects such as allergy or infection will discontinue the medication. If the primary endpoint of 50% reduction in proteinuria or total proteinuria less than 150mg/day is not reached, therapy may be continued for a total of 12 months.

50% Reduction in Proteinuria or Proteinuria < 150mg/Day

1 Participants

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure

Acthar n=1 Participants Acthar 80 units twice weekly for 6 months. If endpoint is not reached, duration may be increased to 12 months. Acthar: Those interested will be started on Acthar 80 units twice weekly for 6 months. Those with minor adverse effects such as weight gain, worsening hypertension, or glucose intolerance will have their doses reduced to 40 unit twice weekly. Those with major adverse effects such as allergy or infection will discontinue the medication. If the primary endpoint of 50% reduction in proteinuria or total proteinuria less than 150mg/day is not reached, therapy may be continued for a total of 12 months.

25% Improvement in the MDRD eGFR

1 Participants

Adverse Events

Acthar

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sanjeev Akkina

Loyola University Medical Center

Phone: 7082166389

Email: sanjeev.akkina@lumc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place