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C1 Esterase Inhibitor

Berinert for Kidney Damage

Phase 1 & 2
Waitlist Available
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Recipients who are ABO compatible with donor allograft
Recipients meeting one of the following criteria: a) Recipients of kidney allograft from KDPI >80 donors b) Recipients of kidney allograft from DCD donors c) Recipients of kidney allograft with CIT > 24 hours d) Recipients of kidney allograft from donor on HD/CRRT prior to death/procurement e) Recipients of kidney allograft with donor terminal creatinine SCr ≥3.0 mg/dL f) Patient risk a total risk index score of >/=3
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 6
Awards & highlights

Study Summary

This trial is testing a drug to see if it can prevent kidney damage in people who are at high risk for it. The trial is double-blind, meaning that neither the participants nor the researchers will know who is receiving the drug and who is receiving the placebo.

Who is the study for?
Adults aged 18-70 on dialysis and candidates for high-risk kidney transplants from deceased donors can join. They must understand the study, use birth control if applicable, and match the donor's blood type. Excluded are those with clotting disorders, recent C1INH treatments, certain infections (Hep B/C, HIV), pregnancy or breastfeeding women, preemptive transplant recipients, zero mismatch kidneys recipients.Check my eligibility
What is being tested?
The trial is testing Berinert (C1INH) against a placebo in preventing delayed graft function after high-risk kidney transplants. It's double-blind and randomized: neither doctors nor patients know who gets real treatment versus placebo. The drug/placebo is given directly into the donated kidney before implantation.See study design
What are the potential side effects?
Potential side effects of Berinert may include allergic reactions or mild symptoms like headache or abdominal pain; however specific side effects will be monitored due to its intraoperative administration into the kidney.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My blood type matches the donor's for the transplant.
Select...
I received a kidney transplant that meets specific high-risk criteria.
Select...
I am between 18 and 70 years old, on dialysis, and can receive a kidney transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Graft Survival 6 Months
Need for Dialysis in the First 30 Days Post-transplant
Renal Function 6 Months
Secondary outcome measures
Development of Donor Specific Antibodies (DSA) at 6 Months
Rejection Episodes at 6 Months
Other outcome measures
Adverse Events in the Study Population

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BerinertExperimental Treatment1 Intervention
Berinert 500 units
Group II: PlaceboPlacebo Group1 Intervention
Normal Saline in identical volume to Berinert
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Berinert
2013
Completed Phase 3
~50

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor
499 Previous Clinical Trials
164,812 Total Patients Enrolled
1 Trials studying Kidney Failure
70 Patients Enrolled for Kidney Failure
OneLegacy FoundationUNKNOWN
1 Previous Clinical Trials
15 Total Patients Enrolled

Media Library

Berinert (C1 Esterase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04696146 — Phase 1 & 2
Kidney Failure Research Study Groups: Berinert, Placebo
Kidney Failure Clinical Trial 2023: Berinert Highlights & Side Effects. Trial Name: NCT04696146 — Phase 1 & 2
Berinert (C1 Esterase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04696146 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients over the age of 35 eligible for this study?

"Eligibility for this study includes being between 18-70 years old, as specified in the inclusion criteria."

Answered by AI

Are volunteers needed for this research project?

"No, this specific trial is not currently recruiting patients. According to the clinicaltrials.gov website, this study was first posted on March 3rd 2021 and was last edited on January 5th 2022. There are 625 other trials that are actively enrolling participants."

Answered by AI

Might I be eligible to participate in this research?

"This study is looking for 40 people, aged 18 to 70, who have kidney diseases. Participants must also meet the following criteria:-Women of childbearing potential must have a negative pregnancy test prior to randomization, and must be on an acceptable form of birth control.-Adult men or women (18-70 years of age) who are on chronic dialysis therapy and acceptable candidates for receipt of a kidney transplant.-Recipients who are ABO compatible with donor allograft.-Understand and sign a written inform consent prior to any study specific procedure.In addition, recipients must"

Answered by AI

Is Berinert a common medication in research trials?

"There are two ongoing clinical trials involving Berinert and none of them have reached Phase 3 yet. The majority of the research is being conducted in Los Angeles, California; however, there are four total locations running these trials."

Answered by AI

Is this a new or unique study?

"Takeda sponsored the initial 106 person Phase 2 trial for Berinert in 2021. Since then, 18310 other clinical trials have been completed. Right now, there are two active studies being conducted for Berinert across 1 city and 2 countries."

Answered by AI

How many people are chosen to participate in this trial?

"As of right now, this study is not looking for any more patients. The trial was first posted on March 3rd 2021 and updated January 5th 2022. For those still interested, there are 623 other trials concerning kidney diseases and 2 involving Berinert that are enrolling participants as we speak."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Berinert (C1INH) vs Placebo for DGF/IRI
Stanley Jordan, MD 2021. "Berinert (C1INH) vs Placebo for DGF/IRI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04696146.
~11 spots leftby Apr 2025
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