NCT05243199

Brief Summary

Hemodialysis or peritoneal dialysis CKD5 patients were randomly divided into Sacubitril/Valsartan and irbesartan treatment groups. Comparing the blood pressure, survival rates, the cardiac function, renal function,and adverse reactions of two groups, to evaluate whether the efficacy and safety of Sacubitril/Valsartan in the treatment of patients with CKD dialysis combined with heart failure is superior to that of irbesartan.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2020

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 16, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2023

Completed
Last Updated

March 17, 2023

Status Verified

March 1, 2023

Enrollment Period

2.6 years

First QC Date

January 19, 2022

Last Update Submit

March 14, 2023

Conditions

CKD5 Stage DialysisHeart Failure

Outcome Measures

Primary Outcomes (1)

  • The effect of ARNI on blood pressure in patients with CKD who are on dialysis

    The evaluation indicator include office blood pressure

    1 year

Secondary Outcomes (3)

  • The effect of ARNI on ambulatory blood pressure

    1 year

  • The effect of ARNI on cardiac function in patients with CKD who are on dialysis

    1 year

  • The safety of ARNI in patients with CKD who are on dialysis

    1 year

Study Arms (2)

Sacubitril/Valsartan

EXPERIMENTAL

The initial dose of 50mg Qd was increased to 50mg Bid after 1 week and maintained to 100mg Bid after 2 weeks if the patient could tolerate it

Drug: Sacubitril/Valsartan

Irbesartan

ACTIVE COMPARATOR

the maximum tolerated dose of irbesartan was administered

Drug: Irbesartan

Interventions

Sacubitril/ValsartanDRUG

The initial dose of 50mg Qd was increased to 50mg Bid after 1 week and maintained to 100mg Bid after 2 weeks if the patient could tolerate it (no follow-up exit criteria were found).

Also known as: ARNI
Sacubitril/Valsartan
IrbesartanDRUG

The Initial dose of 75 mg Qd with sand, such as patients can tolerate and follow-up exit criteria (not appear, to 75 mg Bid to maintain after 1 week, 2 weeks can still be tolerance is raised to 150 mg Bid.

Also known as: ARB
Irbesartan

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CKD stage 5, starting regular hemodialysis or peritoneal dialysis for more than 1 month.
  • NT-proBNP ≥2000pg/ml.
  • hypertension
  • Voluntary informed consent.

You may not qualify if:

  • Unable to tolerate ACEI/ARB class antihypertensive drugs;
  • History of symptomatic hypotension/systolic blood pressure \<100mmHg at screening;
  • Potassium \>6.0mmol/L;
  • History of angioedema;
  • Abnormal liver function such as ALT and/or AST \>=3 times normal upper limit (ULN), total bilirubin \>= 2 times ULN;
  • Moderate to severe anemia (hemoglobin \<80g/L);
  • Cardiac surgery/intervention/cardiac resynchronization therapy has been performed in the past 3 months or is planned in the next 12 months;
  • Newly found malignant tumor (within 3 years), or undergoing radiotherapy/chemotherapy;
  • Pregnant and lactating women, or those of childbearing age who are unable to guarantee effective contraception;
  • New and serious life-threatening infections;
  • Active infectious diseases such as active tuberculosis, active viral hepatitis and HIV infection;
  • Persons suffering from mental disorders and taking psychotropic drugs;
  • Patients with life expectancy less than 12 months;
  • The doctor assessed that the patient was not easy to follow up or had poor compliance and was not suitable for enrollment;
  • Patients who do not want to sign informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nephrology, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Heart Failure

Interventions

sacubitril and valsartan sodium hydrate drug combinationIrbesartan

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsSpiro CompoundsTetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator,Director,Foreign academicians of the French National Academy of Medical Sciences,Director of institute of Nephrology affiliated to Shanghai Jiao Tong University Medical College

Study Record Dates

First Submitted

January 19, 2022

First Posted

February 16, 2022

Study Start

August 1, 2020

Primary Completion

March 1, 2023

Study Completion

March 8, 2023

Last Updated

March 17, 2023

Record last verified: 2023-03

Locations

CN(1)