sacubitril/valsartan for Hemodialysis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Hemodialysis
Sacubitril-valsartan - Drug
Eligibility
18+
All Sexes
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Study Summary

This randomized placebo-controlled clinical trial will evaluate the effect of sacubitril/valsartan (compared with placebo) on echocardiographic measures of hypervolemia, preservation of residual renal function, and key safety parameters in incident hemodialysis patients.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 22 Secondary · Reporting Duration: 18 weeks (includes 2 weeks period off-treatment period)

16 weeks
Adherence to the study drug administration schedule
Change in IVC collapsibility index from baseline to 16 weeks
Change in eGFR from baseline to 16 weeks, assessed by 24-hour averaged urien urea and creatinine clearance
Change in left atrial volume index from baseline to 16 weeks
Change in pre-HD hsTnT from baseline to 16 weeks
Change in pre-dialysis NTpro-BNP from baseline to 16 weeks
Changes in SMaRRT-HD and Dialysis Symptom Index questionnaire scores from baseline to 16 weeks
Proportion of participants able to complete the full 16 weeks of treatment
Proportion of participants able to reach maximum dose titration
Pharmaceutical Preparations
18 weeks
All-cause mortality
Death from cardiovascular causes
Heart failure hospitalization/ hospitalization with volume overload
Heart failure
Rates of recruitment, withdrawal, and loss-to-follow-up
Week 18
Adverse Events
Adverse Events frequency
Angioedema
Angioedema frequency
Hyperkalemia (pre-dialysis serum potassium >5.5 mmol/L)
Hyperkalemia
Inter-dialytic hypotension (symptomatic SBP <90 mmHg or hypotension requiring adjustment in blood pressure medications or treatment in an emergency or hospitalized setting)
Inter-dialytic hypotension (symptomatic SBP <90 mmHg or hypotension requiring adjustment in blood pressure medications or treatment in an emergency or hospitalized setting) frequency
Intra-dialytic hypotension (defined as nadir SBP <90 mmHg if pre-HD SBP≤160 mmHg, or nadir SBP <100 mmHg if pre-HD SBP >160 mmHg)
Hypotension
Serious Adverse Events
Serious Adverse Events frequency
Baseline
Reasons for ineligibility

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

sacubitril/valsartan
1 of 2
placebo
1 of 2

Experimental Treatment

Non-Treatment Group

100 Total Participants · 2 Treatment Groups

Primary Treatment: sacubitril/valsartan · Has Placebo Group · Phase 2

sacubitril/valsartan
Drug
Experimental Group · 1 Intervention: Sacubitril-valsartan · Intervention Types: Drug
placeboPlaceboComparator Group · 2 Interventions: Placebo, Sacubitril-valsartan · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 18 weeks (includes 2 weeks period off-treatment period)

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,122 Previous Clinical Trials
4,062,656 Total Patients Enrolled
Brigham and Women's HospitalLead Sponsor
1,472 Previous Clinical Trials
9,735,165 Total Patients Enrolled
Finnian Mc Causland, MBBCh, MMScPrincipal InvestigatorBrigham and Women's Hospital

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have not taken an ACEi for 36 hours prior to randomization.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: November 13th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References