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Chronic Kidney DiseasesPhase 3NCT03902691

Study of the Efficacy and Safety of Pegol-Sihematide for Anemia in Patients With Chronic Kidney Disease on Dialysis

A Phase 3 study testing Pegol-Sihematide and ESPO in people with Chronic Kidney Diseases, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the effecacy and safety of dialysis centers switching its dialysis patients from using recombinant human erythropoietin injection (CHO Cell) (ESPO) to Pegol-Sihematide injection on hemoglobin levels and other parameters. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Chronic Kidney Diseases
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
372 participants
Where
1 siteChina
Study dates
15 May 2019to 30 May 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 and ≤70 years of age, weight ≥ 45 kilograms (kg).
  • 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.
  • Participants with chronic renal failure on dialysis（hemodialysis/ peritoneal dialysis） for ≥ 3 months prior to randomization，and that the frequency of dialysis was stable and no change in dialysis pattern was observed during the trial.
  • On ESAs treatment for ≥8 weeks prior to screening stage with stable doses and the average doses ≤ 10000 IU/week. And two consecutive hemoglobin values ≥10.0 g/dL and ≤12.0 g/dL within 4 weeks prior to randomization.
  • At least one transferrin saturation (TSAT) ≥ 20% and 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.）.
Show all 21Show fewer
  • 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.
  • Tumor malignancy（non-melanoma skin cancer and carcinoma in situ that have been resected are excluded）.
  • 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.
  • Expected survival less than 12 months.
  • Planed to participate in a kidney transplant or have a kidney donor during the trial.
  • 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, Zhejiang University

    Hangzhou, Zhejiang, 310000

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 Chronic Kidney Disease on Dialysis

The purpose of this study is to evaluate the effecacy and safety of dialysis centers switching its dialysis patients from using recombinant human erythropoietin injection (CHO Cell) (ESPO) to Pegol-Sihematide injection on hemoglobin levels and other parameters.

Read the detailed description

This is a phase 3, randomized, multicenter, open-label, active-controlled, non-inferiority trial to evaluate the efficacy and safety of from ESPO to monthly Pegol-Sihematide injection for the treatment of anemia in participants with chronic kidney disease（CKD）, who are on maintenance dialysis. Study included a period of 4 weeks for screening, 8 weeks for baseline, 16 weeks for dose adjustment, 8 weeks for evaluation, and 28 weeks for extensional treatment period. All patients who passed the screening were received ESPO in baseline period, then, eligible patients were centrally allocated in a 2:1 ratio to receive Pegol-Sihematide or ESPO. 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
Medical subject headings
Renal Insufficiency, Chronic

What participants receive

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

  • Pegol-SihematideDrug

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

  • ESPODrug

    Participants received ESPO by subcutaneous injection or subcutaneous injection weekly. The dose was adjusted throughout the study to maintain a hemoglobin target range of 10.0-12.0 g/dL.

Study groups in NCT03902691
Study groupRoleWhat they receive
Pegol-SihematideExperimentalParticipants received Pegolsihematide by intravenous injection once every 4 weeks.
Receives: Drug: Pegol-Sihematide
ESPO (Recombinant Human Erythropoietin Injection）Active comparatorESPO administration 1 to 3 times 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 defined as the mean of three hemoglobin values: the 4 weeks and 2 weeks recent hemoglobin values taken prior to the day of randomization and the value obtained 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) or every 4 weeks (for the extensional treatment period).

    Measured: Week 17-24

Secondary outcomes (4)

  1. Proportion of Patients Whose Hemoglobin Within ±1.0 g/dL of Baseline during the Evaluation Period

    The hemoglobin value within ±1.0 g/dL of baseline is defined as the difference between the hemoglobin value and the baseline value in the 4 tests in the Evaluation Period was at least 3 times between 1.0g /dL. The Evaluation Period is defined as study weeks 17 through 24.

    Measured: Week 17-24

  2. Mean Dose of Participants With Hemoglobin Within ±1.0 g/dL of Baseline during the Evaluation Period

    Mean dose was calculated at least 3 times from measurements taken during the Evaluation Period (Week 17 to Week 24).

    Measured: Week 17-24

  3. Percentage of Participants With Hemoglobin Within the Target Range of 10.0 to 12.0 g/dL During the Evaluation Period

    The hemoglobin value within the target range of 10.0 to 12.0 g/dL during the evaluation period is defined as HGB values were between 10.0 and 12.0 g/dL in at least 3 of the 4 tests in the efficacy evaluation period.

    Measured: Week 17-24

  4. Average Hemoglobin, RBC, hematokrit and reticulocytes change from baseline

    The baseline hemoglobin value is defined as the mean of three hemoglobin values: the 4 weeks and 2 weeks recent hemoglobin values taken prior to the day of randomization and the value obtained on the day of randomization.

    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 start15 May 2019
  3. Primary completion28 Feb 2021
  4. Study completion30 May 2022

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
372 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03902691
Sponsor's protocol ID
HS-20039-302
Status last verified
Feb 2022
First submitted
13 Mar 2019
Last updated
9 Mar 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhang P, Jiang Y, Xu C, Zhou L, Zheng H, Xie D, Guo M, Huang X, Lu G, Jiang H, Qiu H, Liu B, Li S, Chen Q, Xia Y, Sun B, Yang X, Zhang S, Du S, Sun M, Chen M, Zhong A, Wang X, Zhao Z, Zhou H, Li G, Ren Y, Luo Q, Yang A, Luo P, Tang S, Xu C, Wang Q, Wang X, Yan T, He W, Qin S, Zhang W, Lv L, Wang C, Liu H, Li J, Wu Q, Pan C, Li C, He L, Chen J. Pegmolesatide for the treatment of anemia in patients undergoing dialysis: a randomized clinical trial. EClinicalMedicine. 2023 Oct 28;65:102273. doi: 10.1016/j.eclinm.2023.102273. eCollection 2023 Nov.

    PubMed 37954906

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pegol-Sihematide and ESPO in people with Chronic Kidney Diseases, 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: finished, as of the sponsor's last update on 9 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 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?

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 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 NCT03902691, 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 9 Mar 2023.

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