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Plasma Kallikrein Blocker

Lanadelumab for Hemodialysis Complications (Hinder Trial)

Phase 2
Recruiting
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
On thrice-weekly hemodialysis for at least six months
Clinically stable, adequately dialyzed (single-pool Kt/V > 1.2), with polysulphone membrane for at least three consecutive months before the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the second week of the study until the end (week 6)
Awards & highlights

Hinder Trial Summary

This trial is testing whether or not a drug called lanadelumab can help to prevent a condition called dialysis-induced hypotension, which is caused by low blood pressure during hemodialysis.

Who is the study for?
This trial is for adults aged 18-85 with end-stage kidney disease who experience significant blood pressure drops during hemodialysis. Participants must have been on hemodialysis for at least six months, have certain pre-dialytic blood pressure levels, and suffer from symptoms like nausea or dizziness during treatment. They should not be taking immunosuppressants, have recent severe bleeding or heart issues, nor expect a kidney transplant soon.Check my eligibility
What is being tested?
The study tests if Lanadelumab Injection can prevent low blood pressure in patients undergoing hemodialysis compared to a placebo. It's a double-blind trial meaning neither the researchers nor participants know who gets the real medicine versus the placebo to ensure unbiased results.See study design
What are the potential side effects?
While specific side effects of Lanadelumab in this context aren't detailed here, common ones may include injection site reactions, pain or bruising; allergic reactions; and possibly increased risk of infections due to its immune system effects.

Hinder Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been on hemodialysis 3 times a week for over 6 months.
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I have been on stable dialysis with a specific filter for over 3 months.
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I experience a significant drop in blood pressure and symptoms like nausea or dizziness during dialysis.
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I am between 18 and 85 years old.

Hinder Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the second week of the study until the end (week 6)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the second week of the study until the end (week 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
Blood Pressure during hemodialysis
Secondary outcome measures
Hypotensive episodes

Hinder Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: LanadelumabExperimental Treatment1 Intervention
Subjects will receive lanadelumab (300 mg) subcutaneously at the beginning of the study and 14 days later
Group II: PlaceboPlacebo Group1 Intervention
Subjects will receive placebo subcutaneously at the beginning of the study and 14 days later

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
853 Previous Clinical Trials
671,036 Total Patients Enrolled

Media Library

Lanadelumab Injection [Takhzyro] (Plasma Kallikrein Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT05297786 — Phase 2
Hemodialysis Complication Research Study Groups: Lanadelumab, Placebo
Hemodialysis Complication Clinical Trial 2023: Lanadelumab Injection [Takhzyro] Highlights & Side Effects. Trial Name: NCT05297786 — Phase 2
Lanadelumab Injection [Takhzyro] (Plasma Kallikrein Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05297786 — Phase 2

Frequently Asked Questions

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

Who is eligible to enroll in this medical trial?

"To gain admittance to this clinical trial, individuals must be receiving hemodialysis treatments and between the ages of 18-85. The researchers are recruiting approximately 32 participants in total."

Answered by AI

What measures have been taken to guarantee the security of Lanadelumab Injection [Takhzyro] for subjects?

"Takhzyro's safety is rated as a 2 due to its Phase 2 clinical trial status, indicating that while there are some data points supporting its security, there are none affirming the efficacy of this injection."

Answered by AI

Is this trial presently recruiting participants?

"Affirmative. Clinicaltrials.gov has verified that the research initiative, which was initially published on July 27th 2022, is actively recruiting patients. 32 participants are required at a single medical site."

Answered by AI

What is the current population size of this scientific investigation?

"Affirmative. According to the clinicaltrials.gov portal, this medical trial is recruiting participants as of now. The research was initially posted on July 27th 2022 and its details were most recently revised on August 4th 2022 with a requirement for 32 subjects at 1 site."

Answered by AI

Does this experiment include elderly citizens within its recruitment plan?

"To qualify for this medical trial, patients must between 18 and 85 years old. There are 8 distinct studies that include minors while 101 other trials cater to elderly participants."

Answered by AI
~3 spots leftby Jun 2024