CKD5 Stage DialysisPhase 4NCT05243199
Sacubitril/Valsartan for CKD5 Stage Dialysis Patients
A Phase 4 study testing Sacubitril/Valsartan and Irbesartan in people with CKD5 Stage Dialysis and Heart Failure, run by Ruijin Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- CKD5 Stage Dialysis, Heart Failure
- What is being tested?
- Sacubitril/Valsartan and Irbesartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to 8 Mar 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CKD stage 5, starting regular hemodialysis or peritoneal dialysis for more than 1 month.
- NT-proBNP ≥2000pg/ml.
- hypertension
- Voluntary informed consent.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Nephrology, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, Shanghai Municipality
About this study
Official title: Sacubitril/Valsartan for Dialysis Patients With CKD5 Stage Complicated With Hypertension- A Prospective, Randomized, Controlled Multicenter Study
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.
- Conditions
- CKD5 Stage Dialysis, Heart Failure
- Being tested
- Sacubitril/Valsartan, Irbesartan
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacubitril/ValsartanDrug
Also called ARNI
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).
IrbesartanDrug
Also called ARB
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Sacubitril/Valsartan |
| Irbesartan | Active comparator | the maximum tolerated dose of irbesartan was administered Receives: Drug: Irbesartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of ARNI on blood pressure in patients with CKD who are on dialysis
The evaluation indicator include office blood pressure
Measured: 1 year
Secondary outcomes (3)
The effect of ARNI on ambulatory blood pressure
The evaluation indicator include ambulatory blood pressure
Measured: 1 year
The effect of ARNI on cardiac function in patients with CKD who are on dialysis
The evaluation indicators include heart function-related indicators such as NT pro-BNP and EF value
Measured: 1 year
The safety of ARNI in patients with CKD who are on dialysis
The evaluation indicators incidence of death (including death from cardiovascular events or other causes), hyperkalemia and other adverse events.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start1 Aug 2020
- Primary completion1 Mar 2023
- Study completion8 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CKD5 Stage DialysisStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nan Chen,MD, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243199
- Sponsor's protocol ID
- (2020)(137)
- Status last verified
- Mar 2023
- First submitted
- 19 Jan 2022
- Last updated
- 17 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sacubitril/Valsartan for Dialysis Patients With CKD5 Stage Complicated With Hypertension- A Prospective, Randomized, Controlled Multicenter Study
- ClinicalTrials.gov ID
- NCT05243199
- Acronym / sponsor ID
- (2020)(137)
- Conditions
- CKD5 Stage Dialysis, Heart Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 8 Mar 2023 (actual)
- First posted
- 16 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sacubitril/Valsartan | Experimental | Drug: Sacubitril/ValsartanThe 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 |
| Irbesartan | Active comparator | Drug: Irbesartanthe maximum tolerated dose of irbesartan was administered |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- CKD stage 5, starting regular hemodialysis or peritoneal dialysis for more than 1 month.
- NT-proBNP ≥2000pg/ml.
- hypertension
- Voluntary informed consent.
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacubitril/ValsartanAlso: ARNIThe 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). | Drug | Sacubitril/Valsartan |
| IrbesartanAlso: ARBThe 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. | Drug | Irbesartan |
Primary outcome
The effect of ARNI on blood pressure in patients with CKD who are on dialysis
Time frame: 1 year
The evaluation indicator include office blood pressure
3 secondary outcomes
The effect of ARNI on ambulatory blood pressure
Time frame: 1 year
The effect of ARNI on cardiac function in patients with CKD who are on dialysis
Time frame: 1 year
The safety of ARNI in patients with CKD who are on dialysis
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sacubitril/Valsartan and Irbesartan in people with CKD5 Stage Dialysis and Heart Failure, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of ARNI on blood pressure in patients with CKD who are on dialysis (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.