← Back to Search

Bradykinin B2 Receptor Inhibitor

Icatibant for Intradialytic Hypotension

Phase 3
Recruiting
Led By Peter Kotanko, MD, FASN
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients adequately hemodialyzed with a Kt/V ≥ 1.2
Patients on hemodialysis with at least 6 IDH episodes during the last 8 weeks based on medical record assessment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-8 week
Awards & highlights

Study Summary

This trial seeks an alternative to current treatments for patients on hemodialysis suffering from recurrent IDH episodes. There is currently no medication available, so medical interventions are the main methods used to maintain blood pressure. New treatments may reduce mortality rate and give clinicians additional options.

Who is the study for?
This trial is for adults aged 18-80 with end-stage renal disease on hemodialysis for at least 6 months, experiencing low blood pressure during treatment. They must have had at least six episodes of this in the last two months and be otherwise stable. Women under 55 must use contraception and not be pregnant.Check my eligibility
What is being tested?
The study tests if Icatibant can prevent drops in systolic blood pressure during dialysis compared to a placebo. It aims to provide an alternative treatment for patients who frequently experience intradialytic hypotension.See study design
What are the potential side effects?
While specific side effects are not listed here, Icatibant may cause reactions at the injection site, nausea, headache, or increase certain liver enzymes based on its known profile.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My kidney dialysis is working well.
Select...
I am on hemodialysis and have had at least 6 episodes of IDH in the last 8 weeks.
Select...
I am a woman under 55, will use birth control during the study, and have a negative pregnancy test.
Select...
My weight is 150 kg or less.
Select...
I am between 18 and 80 years old.
Select...
My blood pressure before dialysis is between 110 and 170 mmHg.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-8 week
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-8 week for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Blood pressure during hemodialysis
Secondary outcome measures
Hypotension events
Symptomatology associated with hypotension

Side effects data

From 2014 Phase 4 trial • 19 Patients • NCT01457430
1%
Dizziness
1%
Fever
1%
Nausea
1%
Fatigue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Icatibant

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: IcatibantExperimental Treatment1 Intervention
153 mL 0.9% saline bag containing 30 mg icatibant acetate (10 mg/ml) IV at each dialysis treatment for four weeks (12 hemodialysis sessions)
Group II: PlaceboPlacebo Group1 Intervention
153 mL 0.9% saline bag IV at each dialysis treatment at each dialysis treatment for four weeks (12 hemodialysis sessions)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Icatibant
2009
Completed Phase 4
~610

Find a Location

Who is running the clinical trial?

Pharvaris Netherlands B.V.Industry Sponsor
4 Previous Clinical Trials
300 Total Patients Enrolled
Vanderbilt University Medical CenterLead Sponsor
857 Previous Clinical Trials
672,167 Total Patients Enrolled
Renal Research InstituteOTHER
34 Previous Clinical Trials
79,388 Total Patients Enrolled

Frequently Asked Questions

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

How many participants are being selected for this investigation?

"Affirmative. Clinicaltrials.gov reveals that this medical inquiry, published on December 11th 2023 and last edited on the fifteenth of the same month is actively seeking participants. 26 patients are required between 1 trial location."

Answered by AI

Is this clinical investigation open to adults older than eighteen?

"This trial will accept participants who are between 18 and 80 years of age."

Answered by AI

Is registration currently available for this experiment?

"Correct. Data hosted on clinicaltrials.gov reveals that this medical experiment, initially posted on December 11th 2023, is presently recruiting participants. Approximately 26 individuals must be recruited from a single centre."

Answered by AI

What potential adverse effects could result from using Icatibant?

"We rate the safety of Icatibant a 3, as it has reached Phase 3 clinical trials and evidence of its efficacy along with multiple rounds of data for safety already exist."

Answered by AI

Who meets the criteria to participate in this clinical trial?

"This clinical trial is enrolling 26 individuals who have experienced intradialytic hypotension and are aged between 18-80. In order to qualify, applicants must fulfill the following criteria: they should be within this age range, have undergone hemodialysis for at least 6 months with 3 sessions a week, been diagnosed with IDH episodes in their medical record during the last 8 weeks, present pre-dialysis systolic blood pressure levels between 110 - 170 mmHg as measured by two consecutive readings; possess adequate hemodialysis (Kt/V ≥ 1.2), not altered any of their treatment regimen in"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 Receptor
Jorge Gamboa 2023. "Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 Receptor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05834777.
~17 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top