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Angiotensin-Neprilysin Inhibitor

Sacubitril-Valsartan for Hemodialysis Patients

Phase 2
Recruiting
Led By Finnian Mc Causland, MBBCh, MMSc
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults ≥18 years initiating HD (within 90 days of first HD session)
Thrice-weekly HD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 weeks (includes 2 weeks period off-treatment period)
Awards & highlights

Study Summary

This trialwill test how a drug affects people with kidney failure and how safe it is.

Who is the study for?
Adults over 18 who recently started hemodialysis can join this trial. They must have stable blood pressure, not be on certain heart medications, and able to consent. Excluded are those with recent major heart issues, planned transplants, severe liver disease, untreated serious arrhythmias or cancer within the last year.Check my eligibility
What is being tested?
The trial tests if sacubitril-valsartan is better than a placebo for managing fluid overload and preserving kidney function in new hemodialysis patients. It's randomized: participants won't choose which treatment they get.See study design
What are the potential side effects?
Possible side effects include low blood pressure, high potassium levels, worsening kidney function, dizziness or swelling of the face and throat (angioedema), especially in people previously sensitive to similar drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 or older and started hemodialysis within the last 90 days.
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I am on a thrice-weekly hemodialysis schedule.
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My blood pressure has been stable and above 110 mmHg before dialysis, without needing medication for low blood pressure.
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I haven't taken ACE inhibitors in the last 36 hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 weeks (includes 2 weeks period off-treatment period)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 weeks (includes 2 weeks period off-treatment period) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in left atrial volume index from baseline to 16 weeks
Secondary outcome measures
Adherence to the study drug administration schedule
Adverse Events frequency
Angioedema frequency
+13 more
Other outcome measures
All-cause mortality
Change in pre-HD hsTnT from baseline to 16 weeks
Death from cardiovascular causes
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: sacubitril/valsartanExperimental Treatment1 Intervention
Participants will take sacubitril/valsartan, beginning dose of 24/26mg twice daily, with titration to target dose of 97/103 mg twice daily over the first four weeks. Patients will remain on the maximally tolerated dose for the remaining 12 weeks (total on-drug period of 16 weeks) before stopping drug and being followed for a further two weeks (total study time of 18 weeks).
Group II: placeboPlacebo Group2 Interventions
Participants will take equivalent placebo, beginning equivalent dose of 24/26mg twice daily, with titration to target equivalent dose of 97/103 mg twice daily over the first four weeks. Patients will remain on the maximally tolerated dose for the remaining 12 weeks (total on-drug period of 16 weeks) before stopping drug/placebo and being followed for a further two weeks (total study time of 18 weeks).

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,586 Previous Clinical Trials
11,459,514 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,331 Previous Clinical Trials
4,319,005 Total Patients Enrolled
Finnian Mc Causland, MBBCh, MMScPrincipal InvestigatorBrigham and Women's Hospital

Media Library

Sacubitril-valsartan (Angiotensin-Neprilysin Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05498181 — Phase 2
Hemodialysis Research Study Groups: sacubitril/valsartan, placebo
Hemodialysis Clinical Trial 2023: Sacubitril-valsartan Highlights & Side Effects. Trial Name: NCT05498181 — Phase 2
Sacubitril-valsartan (Angiotensin-Neprilysin Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05498181 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this study still have open enrollment?

"Affirmative. Clinicaltrials.gov conveys that the trial, which was initially shared on October 11th 2022 and recently modified on October 23rd 2022, is actively searching for 100 participants from a solitary medical site."

Answered by AI

To what extent is this trial being participated in by individuals?

"Affirmative. Clinicaltrials.gov data confirms that this clinical trial, which was first posted on October 11th 2022 is actively recruiting patients. 100 individuals need to be enrolled from a single site."

Answered by AI

Is sacubitril/valsartan a viable treatment option with minimal risk?

"The safety of sacubitril/valsartan has been rated 2, as the clinical trial is currently in its second phase. At this point there is evidence to demonstrate safety but not efficacy."

Answered by AI
~61 spots leftby Mar 2026