Trial Outcomes & Findings for Berinert (C1INH) vs Placebo for DGF/IRI (NCT NCT04696146)

NCT ID: NCT04696146

Last Updated: 2024-12-04

Results Overview

The percentage of patients enrolled who require at least one session of dialysis in the first 30 days post transplant.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 45 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2024-12-04

Participant Flow

Participant milestones

Measure	Berinert Berinert 500 units Berinert: Intrarenal dose of 500 U of Berinert	Placebo Normal Saline in identical volume to Berinert Placebo: Normal Saline placebo
Overall Study STARTED	21	24
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Measure	Berinert Berinert 500 units Berinert: Intrarenal dose of 500 U of Berinert	Placebo Normal Saline in identical volume to Berinert Placebo: Normal Saline placebo
Overall Study Transplant Cancelled and did not proceed with study	0	4
Overall Study Off hours issue with product	1	0

Baseline Characteristics

Berinert (C1INH) vs Placebo for DGF/IRI

Baseline characteristics by cohort

Measure	Berinert n=20 Participants Berinert 500 units Berinert: Intrarenal dose of 500 U of Berinert	Placebo n=20 Participants Normal Saline in identical volume to Berinert Placebo: Normal Saline placebo	Total n=40 Participants Total of all reporting groups
Age, Continuous	59 years n=5 Participants	63 years n=7 Participants	59 years n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	4 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	16 Participants n=7 Participants	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

The percentage of patients enrolled who require at least one session of dialysis in the first 30 days post transplant.

Outcome measures

Measure	Berinert n=20 Participants Berinert 500 units Berinert: Intrarenal dose of 500 U of Berinert	Placebo n=20 Participants Normal Saline in identical volume to Berinert Placebo: Normal Saline placebo
Need for Dialysis in the First 30 Days Post-transplant	10 Participants	10 Participants

PRIMARY outcome

Timeframe: 6 months

eGFR at 6M post-transplant

Outcome measures

Measure	Berinert n=20 Participants Berinert 500 units Berinert: Intrarenal dose of 500 U of Berinert	Placebo n=20 Participants Normal Saline in identical volume to Berinert Placebo: Normal Saline placebo
Renal Function 6 Months	54 ml/min/1.73m^2 Standard Deviation 19	42 ml/min/1.73m^2 Standard Deviation 14

PRIMARY outcome

Timeframe: 6 months

Number of participants with graft survival at 6 Months

Outcome measures

Measure	Berinert n=20 Participants Berinert 500 units Berinert: Intrarenal dose of 500 U of Berinert	Placebo n=20 Participants Normal Saline in identical volume to Berinert Placebo: Normal Saline placebo
Graft Survival 6 Months	20 Participants	20 Participants

SECONDARY outcome

Timeframe: Month 6

Number of participants with a rejection episodes by day 180

Outcome measures

Measure	Berinert n=20 Participants Berinert 500 units Berinert: Intrarenal dose of 500 U of Berinert	Placebo n=20 Participants Normal Saline in identical volume to Berinert Placebo: Normal Saline placebo
Rejection Episodes at 6 Months	3 Participants	0 Participants

SECONDARY outcome

Timeframe: Month 6

Number of participants with Donor Specific Antibodies (DSA) at 6 Months

Outcome measures

Measure	Berinert n=20 Participants Berinert 500 units Berinert: Intrarenal dose of 500 U of Berinert	Placebo n=20 Participants Normal Saline in identical volume to Berinert Placebo: Normal Saline placebo
Development of Donor Specific Antibodies (DSA) at 6 Months	1 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 6

Number of participants with an adverse events and serious adverse events

Outcome measures

Measure	Berinert n=20 Participants Berinert 500 units Berinert: Intrarenal dose of 500 U of Berinert	Placebo n=20 Participants Normal Saline in identical volume to Berinert Placebo: Normal Saline placebo
Adverse Events in the Study Population	16 Participants	17 Participants

Adverse Events

Berinert

Serious events: 6 serious events

Other events: 13 other events

Deaths: 0 deaths

Placebo

Serious events: 4 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	Berinert n=20 participants at risk Berinert 500 units Berinert: Intrarenal dose of 500 U of Berinert	Placebo n=20 participants at risk Normal Saline in identical volume to Berinert Placebo: Normal Saline placebo
Infections and infestations Pneumonia	5.0% 1/20 • Number of events 1 • Adverse Event monitoring occurred from study enrollment to Day 180.	5.0% 1/20 • Number of events 1 • Adverse Event monitoring occurred from study enrollment to Day 180.
Infections and infestations COVID-19	5.0% 1/20 • Number of events 1 • Adverse Event monitoring occurred from study enrollment to Day 180.	0.00% 0/20 • Adverse Event monitoring occurred from study enrollment to Day 180.
Infections and infestations Fever/sepsis	0.00% 0/20 • Adverse Event monitoring occurred from study enrollment to Day 180.	10.0% 2/20 • Number of events 2 • Adverse Event monitoring occurred from study enrollment to Day 180.
Infections and infestations Urinary Tract Infection	0.00% 0/20 • Adverse Event monitoring occurred from study enrollment to Day 180.	5.0% 1/20 • Number of events 1 • Adverse Event monitoring occurred from study enrollment to Day 180.
Renal and urinary disorders Acute Kidney Injury	10.0% 2/20 • Number of events 2 • Adverse Event monitoring occurred from study enrollment to Day 180.	10.0% 2/20 • Number of events 2 • Adverse Event monitoring occurred from study enrollment to Day 180.
General disorders Hyperkalemia	0.00% 0/20 • Adverse Event monitoring occurred from study enrollment to Day 180.	10.0% 2/20 • Number of events 3 • Adverse Event monitoring occurred from study enrollment to Day 180.
Renal and urinary disorders Urinary retention	5.0% 1/20 • Number of events 1 • Adverse Event monitoring occurred from study enrollment to Day 180.	0.00% 0/20 • Adverse Event monitoring occurred from study enrollment to Day 180.
Cardiac disorders Hypertensive urgency	0.00% 0/20 • Adverse Event monitoring occurred from study enrollment to Day 180.	5.0% 1/20 • Number of events 1 • Adverse Event monitoring occurred from study enrollment to Day 180.
Cardiac disorders Hypotension	5.0% 1/20 • Number of events 1 • Adverse Event monitoring occurred from study enrollment to Day 180.	5.0% 1/20 • Number of events 1 • Adverse Event monitoring occurred from study enrollment to Day 180.
Gastrointestinal disorders Recurrent intra-abdominal fluid collection	5.0% 1/20 • Number of events 1 • Adverse Event monitoring occurred from study enrollment to Day 180.	0.00% 0/20 • Adverse Event monitoring occurred from study enrollment to Day 180.
General disorders Generalized weakness	0.00% 0/20 • Adverse Event monitoring occurred from study enrollment to Day 180.	5.0% 1/20 • Number of events 1 • Adverse Event monitoring occurred from study enrollment to Day 180.
Gastrointestinal disorders Partial small bowel obstruction	5.0% 1/20 • Number of events 2 • Adverse Event monitoring occurred from study enrollment to Day 180.	0.00% 0/20 • Adverse Event monitoring occurred from study enrollment to Day 180.
General disorders Visual disturbance (black spots), convulsions	5.0% 1/20 • Number of events 1 • Adverse Event monitoring occurred from study enrollment to Day 180.	0.00% 0/20 • Adverse Event monitoring occurred from study enrollment to Day 180.

Other adverse events

Measure	Berinert n=20 participants at risk Berinert 500 units Berinert: Intrarenal dose of 500 U of Berinert	Placebo n=20 participants at risk Normal Saline in identical volume to Berinert Placebo: Normal Saline placebo
General disorders Hyperkalemia	30.0% 6/20 • Number of events 6 • Adverse Event monitoring occurred from study enrollment to Day 180.	55.0% 11/20 • Number of events 12 • Adverse Event monitoring occurred from study enrollment to Day 180.
Endocrine disorders Hyperglycemia	25.0% 5/20 • Number of events 5 • Adverse Event monitoring occurred from study enrollment to Day 180.	30.0% 6/20 • Number of events 6 • Adverse Event monitoring occurred from study enrollment to Day 180.
Blood and lymphatic system disorders Thrombocytopenia	30.0% 6/20 • Number of events 6 • Adverse Event monitoring occurred from study enrollment to Day 180.	20.0% 4/20 • Number of events 4 • Adverse Event monitoring occurred from study enrollment to Day 180.

Additional Information

Noriko Ammerman

Cedars-Sinai Medical Center

Phone: 3102488186

Email: noriko.ammerman@cshs.org

Results disclosure agreements

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