Trial Outcomes & Findings for Adrenocorticotropic Hormone in Membranous Nephropathy (NCT NCT03025828)

Results Overview

Change in proteinuria at baseline versus after 12 months of treatment as measured by urine protein/creatinine ratio

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

5 participants

Primary outcome timeframe

baseline and 12 months

Results posted on

2022-08-15

Participant Flow

Enrollment from March 2018 and June 2019

Participant milestones

Participant milestones
Measure	Acthar Acthar will be administered subcutaneously (SC) 80 units for the first week and then 80 units twice weekly for 6 months
Overall Study STARTED	5
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Acthar Acthar will be administered subcutaneously (SC) 80 units for the first week and then 80 units twice weekly for 6 months
Overall Study Lost to Follow-up	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acthar n=4 Participants Acthar administered subcutaneously (SC) 80 units for the first week and then 80 units twice weekly for 6 months of treatment with a cumulative dose exposure of 3,920 units.
Age, Continuous	53.75 years STANDARD_DEVIATION 8.098 • n=4 Participants
Sex: Female, Male Female	0 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=4 Participants
Serum albumin	3 g/dL STANDARD_DEVIATION 1.01 • n=4 Participants
Serum creatine	0.965 mg/dL STANDARD_DEVIATION 0.118 • n=4 Participants
Negative for Anti-PLA2R Ab	4 Participants n=4 Participants
Urine protein/creatinine ratio (P/C)	6.173 g/g STANDARD_DEVIATION 3.545 • n=4 Participants
Number of Participants with previous treatment	2 Participants n=4 Participants

PRIMARY outcome

Timeframe: baseline and 12 months

Change in proteinuria at baseline versus after 12 months of treatment as measured by urine protein/creatinine ratio

Outcome measures

Outcome measures
Measure	Acthar n=4 Participants Acthar administered subcutaneously (SC) 80 units for the first week and then 80 units twice weekly for 6 months of treatment with a cumulative dose exposure of 3,920 units.
Change in Proteinuria baseline	4.56 ratio Interval 4.41 to 6.32
Change in Proteinuria 12 months	1.36 ratio Interval 1.1 to 1.78

SECONDARY outcome

Timeframe: 12 months

Complete (proteinuria reduction \<500mg/24h) or partial (urinary protein excretion (P/C) \<3.0 g/g (with at least 50% reduction versus baseline) in at least two consecutive visits) remission.

Outcome measures

Outcome measures
Measure	Acthar n=4 Participants Acthar administered subcutaneously (SC) 80 units for the first week and then 80 units twice weekly for 6 months of treatment with a cumulative dose exposure of 3,920 units.
Number of Participants With Complete or Partial Remission complete remission	0 Participants
Number of Participants With Complete or Partial Remission partial remission	4 Participants

SECONDARY outcome

Timeframe: baseline 6 months, 12 months

Change in serum albumin from baseline

Outcome measures

Outcome measures
Measure	Acthar n=4 Participants Acthar administered subcutaneously (SC) 80 units for the first week and then 80 units twice weekly for 6 months of treatment with a cumulative dose exposure of 3,920 units.
Change in Serum Albumin baseline and 6 months	3.0 g/dl Interval 2.03 to 3.98
Change in Serum Albumin baseline and 12 months	3.65 g/dl Interval 3.4 to 4.2

SECONDARY outcome

Timeframe: baseline and 12 months

GFR measures kidney function.

Outcome measures

Outcome measures
Measure	Acthar n=4 Participants Acthar administered subcutaneously (SC) 80 units for the first week and then 80 units twice weekly for 6 months of treatment with a cumulative dose exposure of 3,920 units.
Estimated Glomerular Filtration Rate (GFR) baseline	90.5 mL/min Interval 74.74 to 103.3
Estimated Glomerular Filtration Rate (GFR) 12 months	80.5 mL/min Interval 66.0 to 101.8

SECONDARY outcome

Timeframe: 12 months

Population: Data not collected

Number of anti-PLA2R memory B cells

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: Data not collected

blood levels Number of anti-PLA2R memory B cells

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline and 12 months

blood levels - one single cell subset identified by different markers

Outcome measures

Outcome measures
Measure	Acthar n=4 Participants Acthar administered subcutaneously (SC) 80 units for the first week and then 80 units twice weekly for 6 months of treatment with a cumulative dose exposure of 3,920 units.
Change in CD4+CD25+CD127low T Regulatory Cells/CD4+ T Cell Ratio Baseline	0.04 ratio Interval 0.03 to 0.06
Change in CD4+CD25+CD127low T Regulatory Cells/CD4+ T Cell Ratio 12 Months	0.12 ratio Interval 0.08 to 0.14

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

Dr. Kirk Campbell

Icahn School of Medicine at Mount Sinai

Phone: 212-241-6271

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place