Hemodialysis ComplicationPhase 2HinderNCT05297786
Hemodialysis.-Induced Hypotension Therapy for End Stage Kidney Disease
A Phase 2 study testing Lanadelumab Injection [Takhzyro] in people with Hemodialysis Complication and Hypotension of Hemodialysis, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Bradykinin is a potent vasodilator that is formed by the activation of the kallikrein-kinin system. We and others have shown that bradykinin increased during hemodialysis; however, the role of bradykinin in dialysis-induced hypotension (DIH) has not been evaluated. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hemodialysis Complication, Hypotension of Hemodialysis
- What is being tested?
- Lanadelumab Injection [Takhzyro]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2022to 26 Sep 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects age 18 to 85 years
- 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
- Subjects with pre-dialytic systolic blood pressure between 110 and 170 mmHg.
- Subjects with a reduction of systolic blood pressure during hemodialysis equal to or greater than 30 mmHg, with associated symptoms such as nausea, vomiting, muscle cramps, dizziness, or anxiety.
- Hypotensive episodes should occur four times or more in four weeks (12 hemodialysis sessions).
Who cannot join
- Subjects with intradialytic hypotension that require the use of pharmacological intervention such as midodrine or vasopressin
- Subjects with pre-dialytic systolic blood pressure greater than 170 mmHg or diastolic blood pressure greater than 110 mmHg
- History of myocardial infarction or cerebrovascular event within 3 months
- History of serious hemorrhage (including cerebral hemorrhage) in the past 6 months
- Advanced liver disease
- Ejection fraction less than 30%
Show all 14Show fewer
- Anticipated live donor kidney transplant
- A history of poor adherence to hemodialysis or medical regimen
- Severe anemia (hemoglobin less than 8 g/dl) requiring blood transfusions
- Use of immunosuppressive drugs within one month before study enrollment
- Active connective tissue disease
- History of acute infections disease within one month before study enrollment
- Inability to provide consent
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Prevention of Dialysis-Induced Hypotension by Inhibiting Plasma Kallikrein
Bradykinin is a potent vasodilator that is formed by the activation of the kallikrein-kinin system. We and others have shown that bradykinin increased during hemodialysis; however, the role of bradykinin in dialysis-induced hypotension (DIH) has not been evaluated. Preliminary results from a pilot clinical trial showed that bradykinin B2 receptor blockade with icatibant prevents excessive blood pressure during hemodialysis. Thus, in this study, we will test the overarching hypothesis that blockade plasma kallikrein with lanadelumab would ameliorate the reduction of blood pressure during hemodialysis in patients who are prone to DIH. For this purpose, we will conduct a parallel arm, double-blind placebo-controlled trial, using lanadelumab to evaluate the occurrence of
- Being tested
- Lanadelumab Injection [Takhzyro], Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lanadelumab Injection [Takhzyro]Drug
Lanadelumab 300 mg subcutaneous injection
PlaceboDrug
Placebo injection
| Study group | Role | What they receive |
|---|---|---|
| Lanadelumab | Experimental | Subjects will receive lanadelumab (300 mg) subcutaneously at the beginning of the study and 14 days later Receives: Drug: Lanadelumab Injection [Takhzyro] |
| Placebo | Placebo comparator | Subjects will receive placebo subcutaneously at the beginning of the study and 14 days later Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure During Hemodialysis
Systolic blood pressure pre and post hemodialysis at baseline and at the end of the study
Measured: Pre-hemodialysis and post-hemodialysis, up to 4.5 hours, at baseline and at the end of the study (week 6)
Secondary outcomes (1)
Episodes
Number of hypotensive episodes during hemodialysis after the initiation of the treatment
Measured: From the first week of the study until the end (week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start27 Jul 2022
- Primary completion26 Sep 2024
- Study completion26 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hemodialysis ComplicationStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Gamboa, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05297786
- Sponsor's protocol ID
- 210633
- Acronym
- Hinder
- Status last verified
- Jul 2026
- First submitted
- 17 Mar 2022
- Last updated
- 19 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Dialysis-Induced Hypotension by Inhibiting Plasma Kallikrein
- ClinicalTrials.gov ID
- NCT05297786
- Acronym / sponsor ID
- Hinder / 210633
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 27 Jul 2022 (actual)
- Primary completion
- 26 Sep 2024 (actual)
- Study completion
- 26 Sep 2024 (actual)
- First posted
- 28 Mar 2022 (actual)
- Results
- Posted 20 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bradykinin is a potent vasodilator that is formed by the activation of the kallikrein-kinin system. We and others have shown that bradykinin increased during hemodialysis; however, the role of bradykinin in dialysis-induced hypotension (DIH) has not been evaluated. Preliminary results from a pilot clinical trial showed that bradykinin B2 receptor blockade with icatibant prevents excessive blood pressure during hemodialysis. Thus, in this study, we will test the overarching hypothesis that blockade plasma kallikrein with lanadelumab would ameliorate the reduction of blood pressure during hemodialysis in patients who are prone to DIH. For this purpose, we will conduct a parallel arm, double-blind placebo-controlled trial, using lanadelumab to evaluate the occurrence of
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lanadelumab | Experimental | Drug: Lanadelumab Injection [Takhzyro]Subjects will receive lanadelumab (300 mg) subcutaneously at the beginning of the study and 14 days later |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will receive placebo subcutaneously at the beginning of the study and 14 days later |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects age 18 to 85 years
- 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
- Subjects with pre-dialytic systolic blood pressure between 110 and 170 mmHg.
- Subjects with a reduction of systolic blood pressure during hemodialysis equal to or greater than 30 mmHg, with associated symptoms such as nausea, vomiting, muscle cramps, dizziness, or anxiety.
Key exclusion criteria (14 listed)
- Subjects with intradialytic hypotension that require the use of pharmacological intervention such as midodrine or vasopressin
- Subjects with pre-dialytic systolic blood pressure greater than 170 mmHg or diastolic blood pressure greater than 110 mmHg
- History of myocardial infarction or cerebrovascular event within 3 months
- History of serious hemorrhage (including cerebral hemorrhage) in the past 6 months
- Advanced liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lanadelumab Injection [Takhzyro]Lanadelumab 300 mg subcutaneous injection | Drug | Lanadelumab |
| PlaceboPlacebo injection | Drug | Placebo |
Primary outcome
Blood Pressure During Hemodialysis
Time frame: Pre-hemodialysis and post-hemodialysis, up to 4.5 hours, at baseline and at the end of the study (week 6)
Systolic blood pressure pre and post hemodialysis at baseline and at the end of the study
1 secondary outcome
Episodes
Time frame: From the first week of the study until the end (week 6)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
Related trials for Hemodialysis Complication
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
Not yet recruitingPhase 1/2
Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis
End Stage Renal Disease, Fatigue
Active, not recruiting
Group Exercise Program Supported By Audiovisual Media During Hemodialysis
Chronic Kidney Failure, Hemodialysis
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lanadelumab Injection [Takhzyro] in people with Hemodialysis Complication and Hypotension of Hemodialysis, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure During Hemodialysis (time frame: Pre-hemodialysis and post-hemodialysis, up to 4.5 hours, at baseline and at the end of the study (week 6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.