Trial Outcomes & Findings for Hemodialysis.-Induced Hypotension Therapy for End Stage Kidney Disease (NCT NCT05297786)
NCT ID: NCT05297786
Last Updated: 2026-01-20
Results Overview
Systolic blood pressure pre and post hemodialysis at baseline and at the end of the study
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
From the initiation of study until the end (week 6)
Results posted on
2026-01-20
Participant Flow
Participant milestones
| Measure |
Lanadelumab
Patients received 300 mg of lanadelumab subcutaneously on day 0 (the start of the study) and again on day 14
|
Placebo
Patients received a placebo injection subcutaneously on day 0 (the start of the study) and again on day 14.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
|
Overall Study
COMPLETED
|
9
|
12
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
Lanadelumab
Patients received 300 mg of lanadelumab subcutaneously on day 0 (the start of the study) and again on day 14
|
Placebo
Patients received a placebo injection subcutaneously on day 0 (the start of the study) and again on day 14.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Renal transplantation
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Hemodialysis.-Induced Hypotension Therapy for End Stage Kidney Disease
Baseline characteristics by cohort
| Measure |
Lanadelumab
n=14 Participants
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
|
Placebo
n=14 Participants
Subjects will receive placebo subcutaneously at the beginning of the study and 14 days later
Placebo: Placebo injection
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=37 Participants
|
5 Participants
n=44 Participants
|
12 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=37 Participants
|
9 Participants
n=44 Participants
|
16 Participants
n=40 Participants
|
|
Age, Continuous
|
60.9 years
STANDARD_DEVIATION 15.1 • n=37 Participants
|
58.1 years
STANDARD_DEVIATION 13.9 • n=44 Participants
|
59.5 years
STANDARD_DEVIATION 14.3 • n=40 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=37 Participants
|
7 Participants
n=44 Participants
|
11 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=37 Participants
|
7 Participants
n=44 Participants
|
17 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=37 Participants
|
10 Participants
n=44 Participants
|
21 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=37 Participants
|
3 Participants
n=44 Participants
|
6 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
1 Participants
n=44 Participants
|
1 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=37 Participants
|
14 participants
n=44 Participants
|
28 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: From the initiation of study until the end (week 6)Population: Two patients in the placebo arm dropped after receiving the first dose of the study drug
Systolic blood pressure pre and post hemodialysis at baseline and at the end of the study
Outcome measures
| Measure |
Lanadelumab
n=9 Participants
Patients received 300 mg of lanadelumab subcutaneously on day 0 (the start of the study) and again on day 14
|
Placebo
n=14 Participants
Patients received a placebo injection subcutaneously on day 0 (the start of the study) and again on day 14.
|
|---|---|---|
|
Blood Pressure During Hemodialysis
Baseline-Pre hemodialysis
|
155.9 mmHg
Standard Deviation 36.3
|
155.1 mmHg
Standard Deviation 28.8
|
|
Blood Pressure During Hemodialysis
Baseline-Post hemodialysis
|
136.4 mmHg
Standard Deviation 26.8
|
126. mmHg
Standard Deviation 18.3
|
|
Blood Pressure During Hemodialysis
Six-weeks-Pre hemodialysis
|
136.4 mmHg
Standard Deviation 18.5
|
141.5 mmHg
Standard Deviation 22.5
|
|
Blood Pressure During Hemodialysis
Six-weeks-Post hemodialysis
|
131.2 mmHg
Standard Deviation 15.8
|
119.0 mmHg
Standard Deviation 11.2
|
SECONDARY outcome
Timeframe: From the second week of the study until the end (week 6)Number of hypotensive episodes during hemodialysis after the second week of treatment
Outcome measures
Outcome data not reported
Adverse Events
Lanadelumab
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lanadelumab
n=14 participants at risk
Patients received 300 mg of lanadelumab subcutaneously on day 0 (the start of the study) and again on day 14
|
Placebo
n=9 participants at risk
Patients received a placebo injection subcutaneously on day 0 (the start of the study) and again on day 14.
|
|---|---|---|
|
Cardiac disorders
Bradycardia
|
7.1%
1/14 • Number of events 1 • Six weeks
|
0.00%
0/9 • Six weeks
|
|
Blood and lymphatic system disorders
Hemorrhage
|
0.00%
0/14 • Six weeks
|
11.1%
1/9 • Number of events 1 • Six weeks
|
Other adverse events
| Measure |
Lanadelumab
n=14 participants at risk
Patients received 300 mg of lanadelumab subcutaneously on day 0 (the start of the study) and again on day 14
|
Placebo
n=9 participants at risk
Patients received a placebo injection subcutaneously on day 0 (the start of the study) and again on day 14.
|
|---|---|---|
|
Vascular disorders
Arterio-venous fistula occlusion
|
7.1%
1/14 • Number of events 1 • Six weeks
|
0.00%
0/9 • Six weeks
|
|
Gastrointestinal disorders
Nausea or vomiting
|
14.3%
2/14 • Number of events 2 • Six weeks
|
33.3%
3/9 • Number of events 3 • Six weeks
|
|
Nervous system disorders
Headche
|
14.3%
2/14 • Number of events 2 • Six weeks
|
0.00%
0/9 • Six weeks
|
|
Reproductive system and breast disorders
Menstrual cramps
|
7.1%
1/14 • Number of events 1 • Six weeks
|
0.00%
0/9 • Six weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/14 • Six weeks
|
11.1%
1/9 • Number of events 1 • Six weeks
|
|
Skin and subcutaneous tissue disorders
Swollen lips
|
0.00%
0/14 • Six weeks
|
11.1%
1/9 • Number of events 1 • Six weeks
|
|
Cardiac disorders
Syncope
|
0.00%
0/14 • Six weeks
|
11.1%
1/9 • Number of events 1 • Six weeks
|
|
Musculoskeletal and connective tissue disorders
Dorsalgia
|
0.00%
0/14 • Six weeks
|
11.1%
1/9 • Number of events 1 • Six weeks
|
|
Endocrine disorders
Hypoglycemia
|
0.00%
0/14 • Six weeks
|
11.1%
1/9 • Number of events 1 • Six weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place