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Chronic Renal Failure With HemodialysisPhase 2NCT03950687

Study of rESP Injection for the Treatment of Anemia in Chronic Renal Failure Patients With Hemodialysis

A Phase 2 study testing Recombinant Human Erythropoiesis Injection (CHO cell) and Recombinant Erythropoiesis Stimulating Protein Injection(CHO cell) in people with Chronic Renal Failure With 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 The sponsor has not verified this record for over two years, so it may be out of date.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

A phase 2, randomized, open label, active comparator parallel controlled study to explore the dosage regiment of rESP, and evaluate its efficacy, safety and pharmacokinetic characteristics in the treatment of anemia in chronic renal failure patients with hemodialysis Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chronic Renal Failure With Hemodialysis
What is being tested?
Recombinant 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
150 participants
Where
1 siteChina
Study dates
24 Jun 2019to 30 Dec 2020
Phase
Phase 2
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

  • Patients with chronic renal failure are undergoing maintenance hemodialysis for at least 3 months and at least 2 times a week;
  • 18 years old ≤ age ≤ 75 years old, gender is not limited;
  • Being treated with rHuEPO 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;
  • Evaluation of iron status within 4 weeks, transferrin saturation (TSAT) ≥ 20% and serum ferritin (SF) ≥ 200 μg / L;
  • 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;
  • Volunteer as a subject and sign an informed consent form.

Who cannot join

  • Patients who have received or plan to undergo a kidney transplant during the study period, or who plan to undergo other surgery during the study;
  • 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;
  • There are acute or chronic blood loss within the past 3 months, such as gastrointestinal bleeding;
  • The following circumstances (including but not limited to), the investigators evaluated that it is not suitable for enrollment:
  • Kt/V<1.2 or URR<65%;
  • Abnormal liver function (the aspartate aminotransferase or alanine aminotransferase is greater than 3 times the upper limit of normal);
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  • Patients who were positive for anti-HIV, anti-HCV, and Treponema pallidum antibodies;
  • Patiernts who was suffering from severe secondary hyperparathyroidism (sustained blood iPTH/PTH >1000 ng/L);
  • Patiernts who was suffering from malignant hypertension or poor control of blood pressure (systolic blood pressure >180 mmHg or diastolic blood pressure >100 mmHg);
  • 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;
  • Patients with malignant tumors (excluding non-melanoma skin cancer or excised carcinoma in situ);
  • Patients with a history of severe allergies (including drug allergies), allergic to erythropoietin, or allergic to any component of the test drug (such as human serum albumin);
  • The infection is being treated with systemic antibiotics;
  • Those who have received androgen therapy or who have received blood transfusion therapy within the past 8 weeks;
  • 5 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);
  • All epilepsy or epilepsy history except of childhood febrile seizures, post-traumatic or abstinence single seizures;
  • Pregnant women and lactating women;
  • Alcohol, drug or drug addicts;
  • Other factors investigators believe that they may affect the efficacy judgment or is not suitable for participation.

Trial locations and contacts

1 site in 1 country.

Xiangmei Chen, Medical PhD contact

13501261896

xmchen@126.com

China1 site, 1 recruiting

  • The general hospital of the people's liberation army

    Beijing, Beijing Municipality, 100000

    Peipei Liang, PHD

    Xiangmei Chen, PhD

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Randomized, Open Label, Active Comparator Parallel Controlled Phase 2 Clinical Study on Intravenous Administration of rESP Injection for the Treatment of Anemia in Chronic Renal Failure Patients With Hemodialysis.

A phase 2, randomized, open label, active comparator parallel controlled study to explore the dosage regiment of rESP, and evaluate its efficacy, safety and pharmacokinetic characteristics in the treatment of anemia in chronic renal failure patients with hemodialysis

Read the detailed description

In this phase 2, open label, active comparator parallel controlled study, patients were randomly assigned to three study groups: one active comparator control group (rHu EPO, maintaining the same dose and frequency administrated in the sceening period ), and two experimental groups (0.5μg/kg ,once a week; 1.0μg/kg , 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.

Being tested
Recombinant Human Erythropoiesis Injection (CHO cell), Recombinant Erythropoiesis Stimulating Protein Injection(CHO cell)

What participants receive

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

  • Recombinant Human Erythropoiesis Injection (CHO cell)Drug

    Also called rHuEPO

    rHuEPO 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 NCT03950687
Study groupRoleWhat they receive
Control group AActive comparatorintravenous administration, maintaining the same dose and frequency administrated in the sceening period, for 32 weeks
Receives: Drug: Recombinant Human Erythropoiesis Injection (CHO cell)
Experimental group BExperimentalintravenous administration, 0.5μg/kg, once a week, for 32 weeks
Receives: Drug: Recombinant Erythropoiesis Stimulating Protein Injection(CHO cell)
Experimental group CExperimentalintravenous administration, 1μg/kg, 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.

  1. Primary efficacy index :hemoglobin concentration

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

    Measured: 25th-32nd week

Secondary outcomes (13)

  1. Secondary efficacy index:maintenance rate

    the proportion of subjects whose average Hb concentration remained within the target range during the evaluation period

    Measured: 25th-32nd week

  2. Secondary efficacy index :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

  3. Secondary efficacy index: 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

  4. Secondary efficacy index : average weekly dose

    the average weekly dose of the drug during the evaluation period (normalized by body weight)

    Measured: 25th-32nd week

  5. Secondary efficacy index: EPO dose conversion coefficient of rESP

    the EPO dose conversion coefficient of rESP (the average weekly dose of rESP during the screening period) and the dose correlation

    Measured: for 32 weeks

  6. Secondary efficacy index : mean reticulocyte count

    changes in mean values of reticulocyte compared to baseline values during the evaluation period.

    Measured: 25th-32nd week

  7. Secondary efficacy index : 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

  8. Safety indicator: adverse events

    the type, proportion and severity of adverse events

    Measured: for 32 weeks

  9. Safety indicator: number of dose adjustments

    the number of dose adjustments used by the subject during the treatment and evaluation period

    Measured: for 32 weeks

  10. Safety indicator: the ratio of subjects who are adjusted

    the ratio of subjects who are adjusted during the treatment and evaluation period

    Measured: for 32 weeks

  11. Safety indicator: incidence of erythropoietin (EPO) antibodies and anti-rESP antibodies

    incidence of erythropoietin (EPO) antibodies and anti-rESP antibodies

    Measured: for 32 weeks

  12. Maximum Plasma Concentration (Cmax)

    the Cmax of rESP in patients with long-term medication.

    Measured: for 32 weeks

  13. 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. First posted15 May 2019
  2. Study start24 Jun 2019
  3. Primary completion30 Jun 2020 (estimated)
  4. Study completion30 Dec 2020 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03950687
Sponsor's protocol ID
SYSS-SSS06-HD-II-01
Status last verified
Mar 2020
First submitted
10 May 2019
Last updated
9 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Recombinant Human Erythropoiesis Injection (CHO cell) and Recombinant Erythropoiesis Stimulating Protein Injection(CHO cell) in people with Chronic Renal Failure With Hemodialysis, run by Shenyang Sunshine Pharmaceutical Co., LTD. 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 6 inclusion and 20 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 9 Mar 2020. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Xiangmei Chen, Medical PhD (13501261896, xmchen@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary efficacy index :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 NCT03950687.

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 9 Mar 2020.

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