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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 weeks (includes 2 weeks period off-treatment period)
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 weeks (includes 2 weeks period off-treatment period)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 weeks (includes 2 weeks period off-treatment period)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in left atrial volume index from baseline to 16 weeks
Secondary study objectives
Adherence to the study drug administration schedule
Adverse Events frequency
Angioedema frequency
+13 moreOther study objectives
All-cause mortality
Change in pre-HD hsTnT from baseline to 16 weeks
Death from cardiovascular causes
+1 moreTrial 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
1,670 Previous Clinical Trials
11,878,166 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,464 Previous Clinical Trials
4,337,353 Total Patients Enrolled
Finnian Mc Causland, MBBCh, MMScPrincipal InvestigatorBrigham and Women's Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on a thrice-weekly hemodialysis schedule.I am scheduled for a kidney transplant within the next 4 months.I produce less than 100 mL of urine daily.I haven't used any experimental drugs or devices in the last 12 weeks.I am 18 or older and started hemodialysis within the last 90 days.I have not taken sacubitril/valsartan in the last 30 days.I am planning to undergo a procedure to improve blood flow to my heart or brain within 4 months.I have a serious heart valve problem or a type of heart muscle disease.I have had fainting spells due to an untreated heart rhythm problem in the last 3 months.I haven't had a heart attack, stroke, or major heart-related surgery in the last month.I haven't taken any ACE inhibitors in the last 36 hours.I am using two effective birth control methods if I can become pregnant.I have had a heart device implanted recently or plan to soon.My blood pressure has been stable and above 110 mmHg before dialysis, without needing medication for low blood pressure.I have a slow heartbeat or heart block without a pacemaker.I am mentally capable of making my own health decisions.I haven't had cancer in the last year, except for certain skin cancers or cervical cancer that's considered cured.I do not have severe liver disease or significantly high liver enzyme levels.
Research Study Groups:
This trial has the following groups:- Group 1: sacubitril/valsartan
- Group 2: placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.