Kidney Failure, ChronicPhase 3NCT05211167

Phase III Clinical Study of Recombinant Erythropoiesis Stimulating Protein Injection (rESP) in the Treatment of Anemia in Hemodialysis Patients With Chronic Renal Failure

A Phase 3 study testing Human Erythropoiesis Injection (CHO cell) and Recombinant Erythropoiesis Stimulating Protein Injection(CHO cell) in people with Kidney Failure, Chronic and Hemodialysis, run by Shenyang Sunshine Pharmaceutical Co., LTD. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

To verify the efficacy of recombinant erythropoiesis stimulating protein injection (CHO cell) in hemodialysis patients with chronic renal failure anemia maintenance treatment is not inferior to yibio. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Kidney Failure, Chronic, Hemodialysis
What is being tested?: Human Erythropoiesis Injection (CHO cell) and Recombinant Erythropoiesis Stimulating Protein Injection(CHO cell)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 1 siteChina
Study dates: 1 Jul 2021to 30 Dec 2023
Phase: Phase 3
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

Volunteer as a subject must understand the study procedure and sign the informed consent form;
18 years old ≤ age ≤ 75 years old when sign ICF, gender is not limited;
Patients diagnosed with chronic renal failure anemia were receiving maintenance hemodialysis for at least 3 months and 2-3 times a week; The dialysis frequency was stable and there was no change in the dialysis plan throughout the study period;
Before enrollment, patient being treated short-acting EPO stabilization therapy for at least 12 weeks, the average concentration of hemoglobin in the screening period is in the range of 100~120 g/L (including both ends), and the difference is less than 10g/L;
Iron status and dialysis status were evaluated within 4 weeks before enrollment to meet the following requirements:
Transferrin saturation (TSAT) ≥20% and serum ferritin (SF) ≥200 μg/L; Dialysis parameters: urea clearance index spKt/V≥1.2;
Subjects agree to use reliable contraceptives by themselves and their spouses from the screening period to within 3 months after the end of the study;

Who cannot join

Allergic to the investigational drug or any ingredient in the investigational drug or has had a severe allergic reaction to the drug in the past;
Except of renal anemia, there are other diseases that cause chronic anemia (such as sickle cell anemia, myelodysplastic syndrome, hematological malignancies, myeloma, hemolytic anemia, pure red blood cell aplastic anemia), blood systemic disease or coagulopathy;
Patients who have received or plan to have a kidney transplant during the study period, or who plan to have other surgical procedures during the study period (mainly major surgeries, except those with low blood loss that do not affect Hb concentration);
Patients with acute or chronic blood loss (such as upper gastrointestinal bleeding, etc.) within 3 months prior to enrollment were excluded from the scope of hemorrhage caused by minor surgeries such as temporary vascular access required by clinical medical procedures;
Patiernts who was suffering from malignant hypertension or poor control of blood pressure (systolic blood pressure >180 mmHg or diastolic blood pressure >100 mmHg);
The following conditions (including but not limited to) occurred in the laboratory examination during the screening period, and the investigator judged that the participants were not eligible for inclusion: a) Patients who were positive for HBsAg, anti-HIV, anti-HCV, and Treponema pallidum antibodies; b) The aspartate aminotransferase or alanine aminotransferase is greater than 3 times the upper limit of normal; c) Serum albumin < 35g/L;

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Patiernts who was suffering from severe secondary hyperparathyroidism (sustained blood iPTH/PTH >1000 ng/L);
Patients with previous thromboembolic disease (excluding luminal infarction), history of severe hematopoietic system, and high clotting tendency;
Patiernts with severe cardiovascular and cerebrovascular disease, severe or unstable coronary artery disease, heart failure (NYHA class III or IV), temporary vascular access, or myocardial infarction or stroke within 3 months before enrollment;
A history of malignant neoplasms, except for: basal cell or squamous cell carcinoma of the skin determined to be cured or no recurrence within 5 years, with radical excision, or carcinoma in situ at any site;
The researchers identified those with severe infectious disease or chronic, uncontrolled inflammation within the first four weeks of enrollment;
All epilepsy or epilepsy history except of childhood febrile seizures, post-traumatic or abstinence single seizures;
Those who have received androgen therapy or who have received blood transfusion therapy within the past 8 weeks before enrollment;
Patients who had a pacemaker for more than 5 years; If no more than 5 years of cardiac pacemaker working status assessment and test unqualified;
3 months as a subject to participate in other new drug clinical trials or to the group when the withdrawal time is shorter than the five half-life of the test drug (whichever is the longest of the two);
Subjects were in the middle of pregnancy or lactation at the time of enrollment;
Alcohol, drug or drug addicts;
Other conditions that may not be suitable for the study as determined by the investigator.

Trial locations and contacts

1 site in 1 country.

Gang Tong, MD contact

021-60970099

tonggang@3sbio.com

China1 site, 1 recruiting

Chinese PLA General Hospital
Beijing, Beijing Municipality, 200443
XiangMei Chen, MD, 13501261896, Xmchen301@126.com
Recruiting

Other trials in China

About this study

Official title: A Multicenter, Randomized, Parallel-controlled Phase III Trial Comparing the Efficacy and Safety of Recombinant Erythropoiesis Stimulating Protein Injection (CHO Cell) With Ipbio in Maintenance Therapy in Hemodialysis Patients With Anemia in Chronic Renal Failure

Read the detailed description

In this phase 3, open label, active comparator parallel controlled study, patients were randomly assigned to two study groups: one active comparator control group (Human Erythropoietin Injection , maintaining the same dose and frequency administrated in the sceening period ), and experimental groups (50μg, once every two weeks). All the patients were administered intravenously for 32 weeks and were evaluated the efficacy, safety and pharmacokinetic characteristics. During the whole study period, dosage adjustment was not allowed in the first 4 weeks, while in the remaining trial period dosage adjustment was allowed once every two weeks if necessary.

Conditions: Kidney Failure, Chronic, Hemodialysis
Being tested: Human Erythropoiesis Injection (CHO cell), Recombinant Erythropoiesis Stimulating Protein Injection(CHO cell)
Medical subject headings: Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Human Erythropoiesis Injection (CHO cell)Drug
Human Erythropoiesis Injection (CHO cell) is a recombinant human erythropoietin with the same biological effects as natural erythropoietin
Recombinant Erythropoiesis Stimulating Protein Injection(CHO cell)Drug
Also called rESP
rESP is a high glucose medium and long-acting recombinant protein products, containing 165 amino acids by adding 3 glycosylation sites

Study groups in NCT05211167
Study group	Role	What they receive
Group A	Active comparator	Intravenous administration, maintaining the same dose and frequency administrated in the sceening period, for 32 weeks Receives: Drug: Human Erythropoiesis Injection (CHO cell)
Group B	Experimental	Intravenous administration,50μg, once every two weeks, for 32 weeks Receives: Drug: Recombinant Erythropoiesis Stimulating Protein Injection(CHO cell)

What is being measured

The primary outcome is the main question the study is designed to answer.

hemoglobin concentration
the amount of change in mean Hb concentration compared with baseline Hb concentration during the evaluation period
Measured: 25th-32nd week

Secondary outcomes (13)

maintenance rate
the proportion of subjects whose average Hb concentration remained within the target range during the evaluation period
Measured: 25th-32nd week
proportion of subjects
the proportion of subjects whose range of dose adjustments decreased or increased by 25% still did not reach 100-120 g/L (both ends)
Measured: for 32 weeks
proportion of times
the proportion of times the measured Hb concentration remains within the target range during the subject evaluation period
Measured: 25th-32nd week
average weekly dose
the average weekly dose of the drug during the evaluation period
Measured: 25th-32nd week
average hemoglobin concentration
the mean Hb concentration during the evaluation period
Measured: 25th-32nd week
mean reticulocyte count
changes in mean values of reticulocyte compared to baseline values during the evaluation period
Measured: 25th-32nd week
mean red blood cell count
changes in mean values of red blood cell count compared to baseline values during the evaluation period
Measured: 25th-32nd week
adverse events
the type, proportion and severity of adverse events
Measured: for 32 weeks
number of dose adjustments
the number of dose adjustments used by the subject during the treatment and evaluation period
Measured: for 32 weeks
the ratio of subjects who are adjusted
the ratio of subjects who are adjusted during the treatment and evaluation period
Measured: for 32 weeks
incidence of Human Erythropoietin antibodies and anti-rESP antibodies
incidence of Human Erythropoietin antibodies and anti-rESP antibodies
Measured: for 32 weeks
Maximum Plasma Concentration (Cmax)
the Cmax of rESP in patients with long-term medication
Measured: for 32 weeks
Area Under the Curve (AUC)
the AUC of rESP in patients with long-term medication
Measured: for 32 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 202130 Dec 2023

First posted27 Jan 2022
Study start1 Jul 2021
Primary completion30 Jun 2023 (estimated)
Study completion30 Dec 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
More trials run by Shenyang Sunshine Pharmaceutical Co., LTD.The 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 300 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05211167
Sponsor's protocol ID: SYSS-SSS06-HD-III-01
Status last verified: Jan 2022
First submitted: 13 Jan 2022
Last updated: 27 Jan 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

Gang Tong, MD

021-60970099

tonggang@3sbio.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Kidney Failure, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Parallel-controlled Phase III Trial Comparing the Efficacy and Safety of Recombinant Erythropoiesis Stimulating Protein Injection (CHO Cell) With Ipbio in Maintenance Therapy in Hemodialysis Patients With Anemia in Chronic Renal Failure
ClinicalTrials.gov ID: NCT05211167
Acronym / sponsor ID: SYSS-SSS06-HD-III-01
Conditions: Kidney Failure, Chronic, Hemodialysis
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 300 participants (estimated)
Lead sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.Industry (pharma, biotech, devices)
Study start: 1 Jul 2021 (actual)
Primary completion: 30 Jun 2023 (estimated)
Study completion: 30 Dec 2023 (estimated)
First posted: 27 Jan 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group A	Active comparator	Drug: Human Erythropoiesis Injection (CHO cell)Intravenous administration, maintaining the same dose and frequency administrated in the sceening period, for 32 weeks
Group B	Experimental	Drug: Recombinant Erythropoiesis Stimulating Protein Injection(CHO cell)Intravenous administration,50μg, once every two weeks, for 32 weeks

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Volunteer as a subject must understand the study procedure and sign the informed consent form;
18 years old ≤ age ≤ 75 years old when sign ICF, gender is not limited;
Patients diagnosed with chronic renal failure anemia were receiving maintenance hemodialysis for at least 3 months and 2-3 times a week; The dialysis frequency was stable and there was no change in the dialysis plan throughout the study period;
Before enrollment, patient being treated short-acting EPO stabilization therapy for at least 12 weeks, the average concentration of hemoglobin in the screening period is in the range of 100~120 g/L (including both ends), and the difference is less than 10g/L;
Iron status and dialysis status were evaluated within 4 weeks before enrollment to meet the following requirements:

Key exclusion criteria (18 listed)

Allergic to the investigational drug or any ingredient in the investigational drug or has had a severe allergic reaction to the drug in the past;
Except of renal anemia, there are other diseases that cause chronic anemia (such as sickle cell anemia, myelodysplastic syndrome, hematological malignancies, myeloma, hemolytic anemia, pure red blood cell aplastic anemia), blood systemic disease or coagulopathy;
Patients who have received or plan to have a kidney transplant during the study period, or who plan to have other surgical procedures during the study period (mainly major surgeries, except those with low blood loss that do not affect Hb concentration);
Patients with acute or chronic blood loss (such as upper gastrointestinal bleeding, etc.) within 3 months prior to enrollment were excluded from the scope of hemorrhage caused by minor surgeries such as temporary vascular access required by clinical medical procedures;
Patiernts who was suffering from malignant hypertension or poor control of blood pressure (systolic blood pressure >180 mmHg or diastolic blood pressure >100 mmHg);

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
Human Erythropoiesis Injection (CHO cell)Human Erythropoiesis Injection (CHO cell) is a recombinant human erythropoietin with the same biological effects as natural erythropoietin	Drug	Group A
Recombinant Erythropoiesis Stimulating Protein Injection(CHO cell)Also: rESPrESP is a high glucose medium and long-acting recombinant protein products, containing 165 amino acids by adding 3 glycosylation sites	Drug	Group B

Primary outcome

hemoglobin concentration
Time frame: 25th-32nd week
the amount of change in mean Hb concentration compared with baseline Hb concentration during the evaluation period

13 secondary outcomes

maintenance rate
Time frame: 25th-32nd week
proportion of subjects
Time frame: for 32 weeks
proportion of times
Time frame: 25th-32nd week
average weekly dose
Time frame: 25th-32nd week
average hemoglobin concentration
Time frame: 25th-32nd week
mean reticulocyte count
Time frame: 25th-32nd week
mean red blood cell count
Time frame: 25th-32nd week
adverse events
Time frame: for 32 weeks
number of dose adjustments
Time frame: for 32 weeks
the ratio of subjects who are adjusted
Time frame: for 32 weeks
incidence of Human Erythropoietin antibodies and anti-rESP antibodies
Time frame: for 32 weeks
Maximum Plasma Concentration (Cmax)
Time frame: for 32 weeks
Area Under the Curve (AUC)
Time frame: for 32 weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
Individual participant dataSharing planned: Undecided

Related trials for Kidney Failure, Chronic

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
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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.

Gang Tong, MD contact

021-60970099

tonggang@3sbio.com

XiangMei Chen, MD principal investigator

Chinese PLA General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 18 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 27 Jan 2022. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Gang Tong, MD (021-60970099, tonggang@3sbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

hemoglobin concentration (time frame: 25th-32nd week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05211167.

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 27 Jan 2022.