Hemodialysis.-Induced Hypotension Therapy for End Stage Kidney Disease

NCT05297786 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 1 other identifier: 210633
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Hemodialysis Complication; Hypotension of Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Blood Pressure During Hemodialysis

  Systolic blood pressure pre and post hemodialysis at baseline and at the end of the study

  From the initiation of study until the end (week 6)

Secondary Outcomes (1)

• Hypotensive Episodes

  From the second week of the study until the end (week 6)

Study Arms (2)

Lanadelumab

EXPERIMENTAL

Subjects will receive lanadelumab (300 mg) subcutaneously at the beginning of the study and 14 days later

Drug: Lanadelumab Injection [Takhzyro]

Placebo

PLACEBO COMPARATOR

Subjects will receive placebo subcutaneously at the beginning of the study and 14 days later

Drug: Placebo

Interventions

Placebo DRUG

Placebo injection

Placebo

Lanadelumab Injection [Takhzyro] DRUG

Lanadelumab 300 mg subcutaneous injection

Lanadelumab

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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%
• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Interventions

lanadelumab

Results Point of Contact

• Title: Dr. Jorge Gamboa
• Organization: Vanderbilt University Medical Center

jorge.gamboa@vanderbilt.edu

615-343-4176

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: March 28, 2022
• Study Start: July 27, 2022
• Primary Completion: December 30, 2024
• Study Completion: January 31, 2026
• Last Updated: January 20, 2026
• Results First Posted: January 20, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)