Cardio-Renal SyndromeNCT05053893
Roxadustat Combined With Sacubitril Valsartan Sodium Tablets in the Treatment of Cardiorenal Anemia Syndrome
A study testing Roxadustat;Sacubitril Valsartan Sodium Tablets; and EPO; ACEI / ARB in people with Cardio-Renal Syndrome, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
A randomized and parallel controlled trial design of comparing the new treatment group of Roxadustat combined with Sacubitril Valsartan Sodium Tablets with the traditional treatment group of recombinant human erythropoietin (EPO) combined with ACEI or ARB in Chinese patients with cardiorenal anemia syndrome. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cardio-Renal Syndrome
- What is being tested?
- Roxadustat;Sacubitril Valsartan Sodium Tablets; and EPO; ACEI / ARB
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 22 Sep 2021to 1 Sep 2022
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed as regular dialysis patients with cardiorenal anemia syndrome
- Hemoglobin 60-110g / L (twice with an interval of at least 4 days);
- Volunteered to participate
Who cannot join
- Anemia caused by diseases other than CKD
- Malignant tumors
- Active liver disease
- Rheumatic immune diseases in active stage
- Hereditary or idiopathic angioedema
- Systolic blood pressure≥180 mmHg;diastolic blood pressure≥110 mmHg
Show all 13Show fewer
- Acute myocardial infarction and unstable angina pectoris
- Severe parathyroidism
- Active peptic ulcer
- taking aliskiren
- Mental disease
- Alcohol and drug abuse
- Allergy to test drugs
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Nephrology, Affiliated Hospital of Qingdao University
Qingdao, Shangdong, 266003
Gungqun Xing, Doctor, 186661802178, gqx99monash@163.com
About this study
Official title: A Randomized, Parallel Controlled Trial of Roxadustat Combined withSacubitril Valsartan Sodium Tablets in the Treatment of Cardiorenal Anemia Syndrome
A randomized and parallel controlled trial design of comparing the new treatment group of Roxadustat combined with Sacubitril Valsartan Sodium Tablets with the traditional treatment group of recombinant human erythropoietin (EPO) combined with ACEI or ARB in Chinese patients with cardiorenal anemia syndrome.
- Conditions
- Cardio-Renal Syndrome
- Being tested
- Roxadustat;Sacubitril Valsartan Sodium Tablets;, EPO; ACEI / ARB
- Medical subject headings
- Cardio-Renal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roxadustat;Sacubitril Valsartan Sodium Tablets;Drug
Also called Entresto®
Select the appropriate dose according to the patient's situation
EPO; ACEI / ARBDrug
Select the appropriate ACEI /ARB according to the subject's situation or follow its previous medication
| Study group | Role | What they receive |
|---|---|---|
| New treatment group(Roxadustat combined with Sacubitril Valsartan Sodium Tablets) | Experimental | Roxadustat(FibroGen, China), 100mg (45-60kg) or 120mg (≥ 60kg) each time, three times a week, orally on an empty stomach in the morning. The initial dose of Sacubitril Valsartan Sodium Tablets(Novartis, China) is 50mg, once a day, taken on an empty stomach in the morning, and gradually titrated from the minimum dose to the maximum tolerated dose. Receives: Drug: Roxadustat;Sacubitril Valsartan Sodium Tablets; |
| Traditional treatment group(EPO combined with ACEI or ARB ) | Experimental | Recombinant human erythropoietin (SEBOR, 10000 units / Branch) was injected subcutaneously once a week; Perindopril tablets (Servier, China), taken on an empty stomach, gradually titrated from the minimum dose to the maximum tolerated dose. Receives: Drug: EPO; ACEI / ARB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of hemoglobin level before and after treatment
By detecting blood routine,calculate the changes of hemoglobin.Change value of hemoglobin level(g/L) = baseline hemoglobin level(g/L) - hemoglobin level after treatment(g/L)
Measured: Day0-Day90
Changes of ejection fraction before and after treatment
Cardiac ejection fraction was measured by cardiac ultrasound before and after treatment，and change of cardiac ejection fraction(%) = baseline cardiac ejection fraction level(%) - post-treatment cardiac ejection fraction level(%)
Measured: Day0-Day90
Incidence of acute heart failure, acute myocardial infarction, severe hyperkalemia and severe anemia during treatment
Incidence rate = number of patients with the events/ total number of patients included in the study in this group.
Measured: Day0-Day90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start22 Sep 2021 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardio-Renal SyndromeStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guangqun Xing,MD, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05053893
- Sponsor's protocol ID
- XHASB-001
- Status last verified
- Sep 2021
- First submitted
- 12 Sep 2021
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel Controlled Trial of Roxadustat Combined withSacubitril Valsartan Sodium Tablets in the Treatment of Cardiorenal Anemia Syndrome
- ClinicalTrials.gov ID
- NCT05053893
- Acronym / sponsor ID
- XHASB-001
- Conditions
- Cardio-Renal Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 22 Sep 2021 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 23 Sep 2021 (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.
A randomized and parallel controlled trial design of comparing the new treatment group of Roxadustat combined with Sacubitril Valsartan Sodium Tablets with the traditional treatment group of recombinant human erythropoietin (EPO) combined with ACEI or ARB in Chinese patients with cardiorenal anemia syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New treatment group(Roxadustat combined with Sacubitril Valsartan Sodium Tablets) | Experimental | Drug: Roxadustat;Sacubitril Valsartan Sodium Tablets;Roxadustat(FibroGen, China), 100mg (45-60kg) or 120mg (≥ 60kg) each time, three times a week, orally on an empty stomach in the morning. The initial dose of Sacubitril Valsartan Sodium Tablets(Novartis, China) is 50mg, once a day, taken on an empty stomach in the morning, and gradually titrated from the minimum dose to the maximum tolerated dose. |
| Traditional treatment group(EPO combined with ACEI or ARB ) | Experimental | Drug: EPO; ACEI / ARBRecombinant human erythropoietin (SEBOR, 10000 units / Branch) was injected subcutaneously once a week; Perindopril tablets (Servier, China), taken on an empty stomach, gradually titrated from the minimum dose to the maximum tolerated dose. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosed as regular dialysis patients with cardiorenal anemia syndrome
- Hemoglobin 60-110g / L (twice with an interval of at least 4 days);
- Volunteered to participate
Key exclusion criteria (13 listed)
- Anemia caused by diseases other than CKD
- Malignant tumors
- Active liver disease
- Rheumatic immune diseases in active stage
- Hereditary or idiopathic angioedema
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 |
|---|---|---|
| Roxadustat;Sacubitril Valsartan Sodium Tablets;Also: Entresto®Select the appropriate dose according to the patient's situation | Drug | New treatment group(Roxadustat combined with Sacubitril Valsartan Sodium Tablets) |
| EPO; ACEI / ARBSelect the appropriate ACEI /ARB according to the subject's situation or follow its previous medication | Drug | Traditional treatment group(EPO combined with ACEI or ARB ) |
Primary outcome
Changes of hemoglobin level before and after treatment
Time frame: Day0-Day90
By detecting blood routine,calculate the changes of hemoglobin.Change value of hemoglobin level(g/L) = baseline hemoglobin level(g/L) - hemoglobin level after treatment(g/L)
Changes of ejection fraction before and after treatment
Time frame: Day0-Day90
Cardiac ejection fraction was measured by cardiac ultrasound before and after treatment，and change of cardiac ejection fraction(%) = baseline cardiac ejection fraction level(%) - post-treatment cardiac ejection fraction level(%)
Incidence of acute heart failure, acute myocardial infarction, severe hyperkalemia and severe anemia during treatment
Time frame: Day0-Day90
Incidence rate = number of patients with the events/ total number of patients included in the study in this group.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Roxadustat;Sacubitril Valsartan Sodium Tablets; and EPO; ACEI / ARB in people with Cardio-Renal Syndrome, run by The Affiliated Hospital of Qingdao University 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 3 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 23 Sep 2021. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guangqun Xing, Doctor (18661802178, gqx99monash@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of hemoglobin level before and after treatment (time frame: Day0-Day90). The study lists 3 primary outcomes in all. 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 23 Sep 2021.