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Non-Dialysis-Dependent Chronic Kidney DiseasePhase 3NCT03903809

Study of the Efficacy and Safety of Pegol-Sihematide for Anemia in Patients With NDD-CKD

A Phase 3 study testing Pegol-Sihematide and ESPO in people with Non-Dialysis-Dependent Chronic Kidney Disease, run by Jiangsu Hansoh 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The primary objective of this study is to evaluate the safety and efficacy of Pegol-Sihematide, as compared with recombinant human erythropoietin injection (CHO Cell), ESPO, in anemia treatment in patients with non-dialysis-dependent chronic kidney disease. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Pegol-Sihematide and ESPO
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
175 participants
Where
1 siteChina
Study dates
20 Jun 2019to 31 Dec 2022
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:
  • Males or females ≥ 18 years of age.
  • Females of child-bearing potential who are sexually active had to be willing to practice a highly effective method of birth control for at least 4 weeks prior to randomization, and had to be willing to continue contraception until at least 4 weeks after the last dose of study treatment.
  • CKD with an estimated glomerular filtration rate < 60 mL/min/1.73m2 using Collaborative Group on Epidemiology of Chronic Kidney Diseases (CKD-EPI) formula within 4 weeks prior to randomization, and was not expected to begin dialysis for at least 12 weeks.
  • The patient was not received any erythropoiesis stimulating agents (ESAs) treatment within 12 weeks prior to randomization. And two consecutive hemoglobin values ≥ 6.0 g/dL and < 10.0 g/dL within 4 weeks prior to randomization.
  • At least one transferrin saturation (TSAT) ≥ 20% or one serum ferritin (SF) level ≥ 100 ng/ml within 4 weeks prior to randomization. At least one serum folate level and vitamin B12 level ≥ lower limit of normal during the 4 weeks prior to randomization.
  • Patient was informed of the investigational nature of the study and had given written, informed consent in accordance with institutional, local, and national guidelines.

Who cannot join

  • Subjects who meet any of the following exclusion criteria are not to be enrolled in this study:
  • Females who were pregnant or breast-feeding.
  • Red blood cell (RBC) or whole blood transfusion within 12 weeks prior to randomization.
  • Known intolerance to any ESA, parenteral iron supplementation, or PEGylated molecule.
  • Known hematological disease (including but not limited to myelodysplastic syndrome, hematological malignancy, hemoglobinopathy, pure red cell aplasia, hemolytic syndromes, coagulation disorder, etc.) or cause of anemia other than renal disease（e.g. gastrointestinal bleeding or hookworm disease for stool occult blood positive，etc.）.
  • Known autoimmune diseases（e.g. rheumatoid arthritis, systemic lupus erythematosus, anti-neutrophil cytoplasmic antibody related vasculitis, etc.）.
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  • Obvious infection occurred within 4 weeks prior to randomization，per investigator's clinical judgment.
  • Chronic, uncontrolled, or symptomatic inflammatory disease，per investigator's clinical judgment.
  • Uncontrolled or symptomatic secondary hyperparathyroidism，per investigator's clinical judgment.
  • Poorly controlled hypertension within 4 weeks prior to randomization, per investigator's clinical judgment.
  • Chronic congestive heart failure (New York Heart Association Class III~IV).
  • Active hepatitis or any of the following check exceptions: ALT≥ 2 × upper limit of normal (ULN), AST≥ 2 × upper limit of normal (ULN), DBIL≥ 2 × upper limit of normal (ULN).
  • A positive test for HIV antibody.
  • Significant symptoms or diseases within 6 months prior to randomization，and the investigator judged that these diseases or symptoms may affect evaluation or follow-up.
  • Currently receiving and requiring long-term immunosuppressive therapy.
  • Tumor malignancy（non-melanoma skin cancer and carcinoma in situ that have been resected are excluded）.
  • Expected survival less than 12 months.
  • Elective surgery during the study.
  • Expected conception within 4 weeks after the end of the study treatment.
  • The subject has participated in other clinical trial within the 12 weeks prior to randomization and throughout the trial period.
  • Have any other condition or prior therapy that, in the investigator's opinion, would make the subject unsuitable for the study, or unable or unwilling to comply with the study procedures.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510080

Other trials in China

About this study

Official title: A Phase 3, Randomized, Open-Label, Active-Controlled, Multicenter, Non-Inferiority Study to Evaluate the Efficacy and Safety of Pegol-Sihematide for Anemia in Patients With Non-Dialysis-Dependent Chronic Kidney Disease

The primary objective of this study is to evaluate the safety and efficacy of Pegol-Sihematide, as compared with recombinant human erythropoietin injection (CHO Cell), ESPO, in anemia treatment in patients with non-dialysis-dependent chronic kidney disease.

Read the detailed description

This is a phase 3, randomized, multicenter, open-label, active-controlled, non-inferiority trial to evaluate the safety and efficacy of Pegol-Sihematide versus ESPO. Study included a period of 4 weeks for screening, 16 weeks for dose adjustment, 8 weeks for evaluation, and 28 weeks for extensional treatment period. Eligible patients were centrally allocated in a 2:1 ratio to receive Pegol-Sihematide subcutaneously once every 4 weeks, starting at 0.04 mg per kilogram of body weight, or ESPO once every 1 week or 2 weeks, starting dose of 6000 IU per week. Doses of both drugs were adjusted to achieve and maintain hemoglobin levels between 10.0 and 12.0 g per deciliter for 52 weeks or more. The primary efficacy end point was the mean change from the baseline hemoglobin level to the mean level during the evaluation period; non-inferiority was established if the lower limit of the two-sided 95% confidence interval was -1.0 g per deciliter or higher. Cardiovascular safety was evaluated on the basis of an adjudicated composite end point.

Being tested
Pegol-Sihematide, ESPO

What participants receive

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

  • Pegol-SihematideDrug

    Also called HS-20039

    Participants received Pegol-Sihematide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 10.0-12.0 grams per deciliter (g/dL).

  • ESPODrug

    Also called Recombinant Human Erythropoietin Injection

    Participants received ESPO by subcutaneous injection weekly. The starting dose was 6000 IU and was adjusted according to the instruction to maintain a hemoglobin target range of 10.0-12.0 grams per deciliter (g/dL).

Study groups in NCT03903809
Study groupRoleWhat they receive
HS-20039 Pegol-SihematideExperimentalPegol-Sihematide's starting dose of 0.025 milligram per kilogram (mg/kg) administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 13 doses
Receives: Drug: Pegol-Sihematide
ReHuman Erythropoietin InjectionActive comparatorESPO(Recombinant Human Erythropoietin Injection) ESPO's starting dose was 6000 IU per week
Receives: Drug: ESPO

What is being measured

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

  1. The mean change from the baseline hemoglobin level to the mean level during the evaluation period

    The primary efficacy end point is the mean change from the baseline hemoglobin level to the mean level during the evaluation period. The baseline hemoglobin value is the value on the day of randomization. The mean hemoglobin during the evaluation period was calculated as the mean of all available hemoglobin values during that period. Hemoglobin measurements will be performed at baseline and thereafter every 2 weeks (for the dose adjustment and the evaluation periods). Efficacy will be also assessed as the mean change from baseline in hemoglobin levels during 4-week intervals.

    Measured: Week 17-24

Secondary outcomes (5)

  1. The mean change from the baseline hemoglobin level to the mean level at each visit

    The mean change from the baseline hemoglobin level to the mean level at each visit point. Hemoglobin measurements will be performed at every 2 weeks during the dose adjustment period (0-16 weeks) and the evaluation period (17-24 weeks) , and every 4 weeks during the extended period (25-52 weeks).

    Measured: Week 0-52

  2. The proportion of patients with hemoglobin within the target range of 10.0 to 12.0 g/dL during the evaluation period

    The proportion of patients achieving a response (hemoglobin maintain in 10.0 to 12.0 g/dL during the previous 4 weeks), will be measured during the evaluation period.

    Measured: Week 17-24

  3. The mean dose of patients with Pegol-Sihematide achieving a target hemoglobin range during the evaluation period

    The mean dose of patients with Pegol-Sihematide will be calculated for achieving a target hemoglobin range (10.0 to 12.0 g/dL) during the evaluation period.

    Measured: Week 17-24

  4. First time for patients achieving a response to hemoglobin during any treatment periods

    First time for patients achieving a response (hemoglobin increase in ≥ 1.0 g/dL) during any trial periods, including the dose adjustment period (0-16 weeks), the evaluation period (17-24 weeks) and the extended period (25-52 weeks).

    Measured: Week 0-52

  5. First time for patients achieving a target hemoglobin range during any trial periods

    First time for patients achieving a target hemoglobin range (hemoglobin maintain in 10.0 to 12.0 g/dL or increase in ≥ 1.0 g/dL) during any trial periods, including the dose adjustment period (0-16 weeks), the evaluation period (17-24 weeks) and the extended period (25-52 weeks).

    Measured: Week 0-52

Timeline

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

  1. First posted4 Apr 2019
  2. Study start20 Jun 2019
  3. Primary completion14 Oct 2021
  4. Study completion31 Dec 2022 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
175 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03903809
Sponsor's protocol ID
HS-20039-301
Status last verified
Aug 2022
First submitted
4 Mar 2019
Last updated
1 Sep 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Xie J, Yang A, Qiu H, Peng X, Lu W, Huang X, Chen Q, Zhong A, Tang S, Wang Q, Li C, He L, Jia X, Ma A, Wang F, Yu X. Randomized Trial of Pegmolesatide for the Treatment of Anemia in Patients With Nondialysis CKD. Kidney Int Rep. 2024 Dec 6;10(3):720-729. doi: 10.1016/j.ekir.2024.12.002. eCollection 2025 Mar.

    PubMed 40225393

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pegol-Sihematide and ESPO in people with Non-Dialysis-Dependent Chronic Kidney Disease, run by Jiangsu Hansoh 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 7 inclusion and 21 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 1 Sep 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?

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 mean change from the baseline hemoglobin level to the mean level during the evaluation period (time frame: Week 17-24). 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 NCT03903809, which also lists 1 linked publication.

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 1 Sep 2022; AzTrials last refreshed its copy on 8 Nov 2026.

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