Trial Outcomes & Findings for Treatment of Chronic Antibody-mediated Rejection in Kidney Transplant With Acthar (NCT NCT02546492)

Last Updated: 2022-10-06

Results Overview

Participants will be monitored for Serious Adverse Events, as follows (as described in ClinicalTrials.gov) Death, Life-threatening events, Hospitalization (initial or prolonged), Disability and events that requires intervention to prevent permanent impairment or damage. Other (non serious) events which were anticipated or unanticipated (as described in ClinicaTrials.gov) will be monitored. ASSESSMENT: The subjects will be assessed at regular intervals through a questionnaire for Acthar related events, physician evaluation at clinical visits, and self reporting.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

6 participants

Primary outcome timeframe

12 months

Results posted on

2022-10-06

Participant Flow

Participant milestones

Participant milestones
Measure	Acthar The study cohort. In this cohort Acthar gel will be administered to the enrolled patient with chronic antibody-mediated rejection (AMR). Acthar gel: Administration of the study drug in addition to the current maintenance immunosuppressive agents
Overall Study STARTED	6
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Chronic Antibody-mediated Rejection in Kidney Transplant With Acthar

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants Have Biopsy Proven Chronic Antibody Mediated Rejection, and Will Receive Acthar. n=6 Participants In this cohort Acthar gel will be administered to all the enrolled patient with chronic AMR. There is a single arm in this study. Acthar gel: Administration of the study drug in addition to the current maintenance immunosuppressive agents
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	54.5 Years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 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	4 Participants n=5 Participants
Race (NIH/OMB) White	2 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	6 participants n=5 Participants
eGFR (estimated Glomerular Filtration Rate)	49.2 ml/min/1.73 m^2 STANDARD_DEVIATION 14.6 • n=5 Participants
Serum Creatinine	1.75 mg/dl STANDARD_DEVIATION 0.56 • n=5 Participants
Urine Albumin	745 mg/L STANDARD_DEVIATION 771.5 • n=5 Participants
Urine Albumin Creatinine Ratio	722.8 mg/g Creatinine STANDARD_DEVIATION 957.5 • n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: All participants were monitored for adverse events throughout their participation.

Outcome measures

Outcome measures
Measure	Serious Adverse Events (SAE) n=6 Participants All study participants who received the study drug
Safety (Serious Adverse Events)	2 Participants

SECONDARY outcome

Timeframe: 1 year

Population: Study participants who received the study drug

composite of graft loss, death, decrease in eGFR\>10%, and increase in proteinuria

Outcome measures

Outcome measures
Measure	Serious Adverse Events (SAE) n=6 Participants All study participants who received the study drug
Efficacy Outcome Composite outcome	3 Participants
Efficacy Outcome Death	1 Participants
Efficacy Outcome Decreased GFR>10%	1 Participants
Efficacy Outcome Increased proteinuria	1 Participants

Adverse Events

Participants Received Acthar

Serious events: 2 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Participants Received Acthar n=6 participants at risk All participants in the study received Acthar.
Renal and urinary disorders Hospitalized	16.7% 1/6 • Number of events 1 • 12 months
Endocrine disorders Hospitalization	16.7% 1/6 • Number of events 1 • 12 months
General disorders Death	16.7% 1/6 • Number of events 1 • 12 months

Other adverse events

Other adverse events
Measure	Participants Received Acthar n=6 participants at risk All participants in the study received Acthar.
Musculoskeletal and connective tissue disorders Cramps of hands and fingers	16.7% 1/6 • Number of events 1 • 12 months
Nervous system disorders Dizziness and Vertigo	16.7% 1/6 • Number of events 1 • 12 months
Cardiac disorders Tightness of Chest	16.7% 1/6 • Number of events 1 • 12 months
Metabolism and nutrition disorders Weight gain	16.7% 1/6 • Number of events 1 • 12 months
Nervous system disorders Irritablility	16.7% 1/6 • Number of events 1 • 12 months
Endocrine disorders Moon Face (Swelling of face)	16.7% 1/6 • Number of events 1 • 12 months
Vascular disorders Elevated Blood Pressure	16.7% 1/6 • Number of events 1 • 12 months

Additional Information

A Haririan

University of MAryland sSchool of Medicine

Phone: 410-328-5720

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place