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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lanadelumab | Experimental | Subjects will receive lanadelumab (300 mg) subcutaneously at the beginning of the study and 14 days later |
|
| Placebo | Placebo Comparator | Subjects will receive placebo subcutaneously at the beginning of the study and 14 days later |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lanadelumab Injection [Takhzyro] | Drug | Lanadelumab 300 mg subcutaneous injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure During Hemodialysis | Systolic blood pressure pre and post hemodialysis at baseline and at the end of the study | Pre-hemodialysis and post-hemodialysis, up to 4.5 hours, at baseline and at the end of the study (week 6) |
| Measure | Description | Time Frame |
|---|---|---|
| Hypotensive Episodes | Number of hypotensive episodes during hemodialysis after the initiation of the treatment | From the first week of the study until the end (week 6) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lanadelumab | Patients received 300 mg of lanadelumab subcutaneously on day 0 (the start of the study) and again on day 14 |
| FG001 | Placebo | Patients received a placebo injection subcutaneously on day 0 (the start of the study) and again on day 14. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lanadelumab | Subjects will receive lanadelumab (300 mg) subcutaneously at the beginning of the study and 14 days later Lanadelumab Injection [Takhzyro]: Lanadelumab 300 mg subcutaneous injection |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Blood Pressure During Hemodialysis | Systolic blood pressure pre and post hemodialysis at baseline and at the end of the study | Two patients in the placebo arm dropped after receiving the first dose of the study drug | Posted | Mean | Standard Deviation | mmHg | Pre-hemodialysis and post-hemodialysis, up to 4.5 hours, at baseline and at the end of the study (week 6) |
|
Six weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lanadelumab | Patients received 300 mg of lanadelumab subcutaneously on day 0 (the start of the study) and again on day 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | Systematic Assessment | Patient required hospitalization due to symptomatic bradicardia |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arterio-venous fistula occlusion | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jorge Gamboa | Vanderbilt University Medical Center | 615-343-4176 | jorge.gamboa@vanderbilt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 16, 2024 | Dec 30, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C000596550 | lanadelumab |
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| Placebo |
| Drug |
Placebo injection |
|
| Physician Decision |
|
| Adverse Event |
|
| Withdrawal by Subject |
|
Subjects will receive placebo subcutaneously at the beginning of the study and 14 days later
Placebo: Placebo injection
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Hypotensive Episodes | Number of hypotensive episodes during hemodialysis after the initiation of the treatment | Posted | Number | numbers of ocurrence | From the first week of the study until the end (week 6) |
|
|
|
| 0 |
| 14 |
| 1 |
| 14 |
| 4 |
| 14 |
| EG001 | Placebo | Patients received a placebo injection subcutaneously on day 0 (the start of the study) and again on day 14. | 0 | 14 | 3 | 14 | 8 | 14 |
|
| Hemorrhage | Blood and lymphatic system disorders | Systematic Assessment | Upper gastrointestinal bleeding |
|
| Hemorrhage | Blood and lymphatic system disorders | Systematic Assessment | Rectal bleeding |
|
| Nausea or vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Headche | Nervous system disorders | Systematic Assessment |
|
| Menstrual cramps | Reproductive system and breast disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Swollen lips | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Syncope | Cardiac disorders | Systematic Assessment |
|
| Dorsalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hypoglycemia | Endocrine disorders | Systematic Assessment |
|
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