Trial · NCT05297786

Hemodialysis.-Induced Hypotension Therapy for End Stage Kidney Disease

NCT05297786, Phase 2, Completed, Vanderbilt University Medical Center; results first posted 2026-01-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Hemodialysis.-Induced Hypotension Therapy for End Stage Kidney Disease. Trials, record NCT05297786. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05297786

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Hemodialysis.-Induced Hypotension Therapy for End Stage Kidney Disease
NCT number: NCT05297786
Status: Completed
Phases: Phase 2
Enrollment: 28 participants, actual
Lead sponsor: Vanderbilt University Medical Center
Conditions: Hemodialysis Complication, Hypotension of Hemodialysis
Interventions: Lanadelumab Injection [Takhzyro], Placebo
First posted: 2022-03-28
Last updated: 2026-08-19
Results first posted: 2026-01-20

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Blood Pressure During Hemodialysis	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
Secondary	Episodes	From the first week of the study until the end (week 6)	Number of hypotensive episodes during hemodialysis after the initiation of the treatment

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Blood Pressure During Hemodialysis	From the initiation of study until the end (week 6)	Two patients in the placebo arm dropped after receiving the first dose of the study drug	mmHg	MEAN
SECONDARY	Hypotensive Episodes	From the second week of the study until the end (week 6)

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Blood Pressure During Hemodialysis	Lanadelumab	Baseline-Pre hemodialysis	155.9	Standard Deviation 36.3	mmHg
Blood Pressure During Hemodialysis	Placebo	Baseline-Pre hemodialysis	155.1	Standard Deviation 28.8	mmHg
Blood Pressure During Hemodialysis	Lanadelumab	Baseline-Post hemodialysis	136.4	Standard Deviation 26.8	mmHg
Blood Pressure During Hemodialysis	Placebo	Baseline-Post hemodialysis	126.	Standard Deviation 18.3	mmHg
Blood Pressure During Hemodialysis	Lanadelumab	Six-weeks-Pre hemodialysis	136.4	Standard Deviation 18.5	mmHg
Blood Pressure During Hemodialysis	Placebo	Six-weeks-Pre hemodialysis	141.5	Standard Deviation 22.5	mmHg
Blood Pressure During Hemodialysis	Lanadelumab	Six-weeks-Post hemodialysis	131.2	Standard Deviation 15.8	mmHg
Blood Pressure During Hemodialysis	Placebo	Six-weeks-Post hemodialysis	119.0	Standard Deviation 11.2	mmHg

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Lanadelumab	14
Overall Study	STARTED	Placebo	14
Overall Study	COMPLETED	Lanadelumab	9
Overall Study	COMPLETED	Placebo	12
Overall Study	NOT COMPLETED	Lanadelumab	5
Overall Study	NOT COMPLETED	Placebo	2

Source ClinicalTrials.gov

Adverse events24

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Arterio-venous fistula occlusion	Vascular disorders	Lanadelumab	1	14	1
other	Arterio-venous fistula occlusion	Vascular disorders	Placebo	0	9	0
other	Nausea or vomiting	Gastrointestinal disorders	Lanadelumab	2	14	2
other	Nausea or vomiting	Gastrointestinal disorders	Placebo	3	9	3
other	Headche	Nervous system disorders	Lanadelumab	2	14	2
other	Headche	Nervous system disorders	Placebo	0	9	0
other	Menstrual cramps	Reproductive system and breast disorders	Lanadelumab	1	14	1
other	Menstrual cramps	Reproductive system and breast disorders	Placebo	0	9	0
other	Depression	Psychiatric disorders	Lanadelumab	0	14	0
other	Depression	Psychiatric disorders	Placebo	1	9	1

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lanadelumab	0	14
Total, all-cause mortality	Placebo	0	9
Total, other adverse events	Lanadelumab	4	14
Total, other adverse events	Placebo	8	9
Total, serious adverse events	Lanadelumab	1	14
Total, serious adverse events	Placebo	3	9

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Lanadelumab vs Placebo: deaths from any cause	Trial comparisons
Lanadelumab vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT05297786

GET https://conductscience.org/api/trials/v1/NCT05297786/events?page=2

API reference For AI assistants