AzTrials
AzTrials

Dialysis; ComplicationsPhase 4PANGU-stepupNCT07045155

Pegmolesatide Treatment for Anemia in Patients Undergoing Long-term Dialysis

A Phase 4 study testing The Pegmolesatide and Roxadustat Combination Therapy Group (Exploratory Group) and The Pegmolesatide Monotherapy Group (Experimental group) in people with Dialysis; Complications and Chronic Kidney Disease 5D, run by Chinese PLA General Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study is a prospective, multicenter, parallel-controlled, open-label clinical trial, planned to be conducted across multiple research centers in various provinces and cities in China. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
The Pegmolesatide and Roxadustat Combination Therapy Group (Exploratory Group) and The Pegmolesatide Monotherapy Group (Experimental group)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteChina
Study dates
1 Aug 2025to 30 Dec 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged ≥18 years and ≤80 years, with no restrictions on gender.
  • Body weight ≥40 kg and body mass index (BMI) ≥18 kg/m².
  • Subjects who have received hemodialysis or peritoneal dialysis for ≥3 months prior to enrollment;
  • Subjects who have been receiving erythropoiesis-stimulating agents (ESAs) for ≥4 weeks prior to randomization, with an average weekly dose >6000 IU in the last 4 weeks (equivalent dose converted to short-acting EPO >6000 IU, calculated as the total amount of short-acting EPO used in the last 4 weeks divided by 4);
  • The most recent Hb value during the screening period and the average Hb value between screening and baseline visits must be ≥70 to <110 g/L;
  • Hemodialysis patients with serum ferritin levels ≥200 μg/L; peritoneal dialysis patients with serum ferritin levels ≥100 μg/L, and the investigator determines that renal transplant is not required during the trial;
  • Understanding the study procedures and voluntarily signing the Informed Consent Form (ICF).

Who cannot join

  • Known to have active malignancy, polycystic kidney disease, hematologic disorders (including congenital and acquired anemias such as thalassemia, Fanconi anemia, pure red cell aplasia, myelodysplastic syndromes, hemolytic anemia, and coagulation disorders), or other causes of anemia (such as gastrointestinal bleeding or hookworm disease);
  • Known to have experienced stroke, transient ischemic attack, myocardial infarction, thromboembolic events (deep vein thrombosis), pulmonary embolism, or other serious cardiopulmonary diseases within the past 6 months;
  • Received anabolic steroid (e.g., androgen) therapy within 12 weeks prior to randomization;
  • Known to have received red blood cell or whole blood transfusion within 12 weeks prior to the study.
  • History of significant infection within 4 weeks before randomization as determined by the investigator.
  • Confirmed blood pressure measurements at rest and in a conscious state using standard measurement methods, with at least three non-consecutive day readings reaching or exceeding systolic blood pressure (SBP) ≥180 mmHg and/or diastolic blood pressure (DBP) ≥110 mmHg within 4 weeks before enrollment, or changes in antihypertensive medication treatment. The primary basis for judgment is clinic-measured blood pressure values, but "white coat hypertension" should be excluded.
Show all 10Show fewer
  • Known allergy to iron agents or polyethylene glycol.
  • Pregnant or breastfeeding women, women of childbearing age with a positive blood β-HCG test result before the trial, or those planning to become pregnant during the study period.
  • Scheduled for elective surgery during the trial period.
  • Presence of any other factors that the investigator deems unsuitable for participation in this trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ping Li, M.D. contact

+8615810136659

liping.8@163.com

China1 site, 1 recruiting

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100000

    Ping Li, M.D., +8615810136659, liping.8@163.com

    Jingyang Ma, +8613383167358, xzc@bnjf.org.cn

    Recruiting

Other trials in China

About this study

Official title: Pegmolesatide for Anemia Treatment：Investigation Upgrade Therapy in rhuEPO Patients Undergoing Dialysis: A Prospective, Multicenter, Parallel-Group, Controlled, Open-Label Study（PANGU-stepup）

This study is a prospective, multicenter, parallel-controlled, open-label clinical trial, planned to be conducted across multiple research centers in various provinces and cities in China.

It will enroll 240 dialysis-dependent chronic kidney disease (DD-CKD) patients with anemia who have been receiving rHuEPO treatment for at least 4 weeks, with hemoglobin (Hb) levels of ≥70 g/L and <110 g/L. After enrollment, participants will be randomly assigned in a 1:1:1 ratio to the experimental group, control group, and exploratory group. The study will involve a 24-week treatment and observation period, divided into three phases: a screening period (Day -28 to Day -1), a treatment period (Week 0 to Week 16), and an extension period (Week 17 to Week 24).

The primary objective is to assess the impact of the three treatment regimens on the hemoglobin levels of patients with DD-CKD anemia.

Read the detailed description

title： Pegmolesatide for anemia treatment：investigation upgrade therapy in rhuEPO patients undergoing dialysis: A Prospective, Multicenter, Parallel-Group, Controlled, Open-Label Study（PANGU-upgrade） Introduction: Anemia is a primary complication of chronic kidney disease (CKD). In recent years, there have been many effective strategies for treating anemia in CKD, including erythropoiesis-stimulating agents (ESAs), hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs), and erythropoietin (EPO) mimetic peptides (EMPs) such as Pegmolesatide. This study aims to explore the efficacy and safety of switching patients with anemia of dialysis-dependent chronic kidney disease (DD-CKD), whose hemoglobin (Hb) levels have not reached the target after treatment with recombinant human erythropoietin (rHuEPO), to treatment with pegmolesatide.

Methods:

This study is designed as a prospective, multicenter, parallel-controlled, open-label trial. It plans to enroll 240 participants with anemia of dialysis-dependent chronic kidney disease (DD-CKD) who have been receiving recombinant human erythropoietin (rHuEPO) treatment for at least 4 weeks, with hemoglobin (Hb) levels of ≥70 g/L and <110 g/L. Participants will be randomly assigned in a 1:1:1 ratio to the experimental group, the control group, and the exploratory group. The study will consist of a 24-week treatment and observation period, divided into three phases: the screening period (Day -28 to Day -1), the treatment period (Week 0 to Week 16), and the extension period (Week 17 to Week 24).

This study plans to recruit participants from 20 large tertiary hospitals across multiple provinces and cities in China. The primary endpoint of the study is the change in mean hemoglobin (Hb) levels from baseline at weeks 12 to 16 of treatment in the three groups. The study will observe and evaluate the efficacy and safety of switching patients with anemia of dialysis-dependent chronic kidney disease (DD-CKD) who have not achieved target Hb levels after treatment with recombinant human erythropoietin (rHuEPO) to treatment with pegmolesatide alone or pegmolesatide in combination with roxadustat.

Being tested
The rHuEPO Monotherapy Group (Control Group), The Pegmolesatide and Roxadustat Combination Therapy Group (Exploratory Group), The Pegmolesatide Monotherapy Group (Experimental group)
Keywords
recombinant human erythropoietin, erythropoietin mimetic peptides, Pegmolesatide, Dialysis, renal anemia
Medical subject headings
Bronchiolitis Obliterans Syndrome

What participants receive

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

  • The rHuEPO Monotherapy Group (Control Group)Drug

    Also called Control Group

    The rHuEPO Monotherapy Group (Control Group) will be treated with rHuEPO for the first 16 weeks and then switch to Pegmolesatide treatment for the subsequent 8 weeks.

  • The Pegmolesatide and Roxadustat Combination Therapy Group (Exploratory Group)Drug

    Also called Exploratory Group

    The Pegmolesatide and Roxadustat Combination Therapy Group (Exploratory Group) will receive a combination of Pegmolesatide and roxadustat throughout the entire 24-week treatment period.

  • The Pegmolesatide Monotherapy Group (Experimental group)Drug

    Also called Experimental group

    The Pegmolesatide Monotherapy Group (Experimental Group) will receive Pegmolesatide treatment throughout the entire 24-week period.

Study groups in NCT07045155
Study groupRoleWhat they receive
The Pegmolesatide Monotherapy Group (Experimental Group)ExperimentalThe Pegmolesatide Monotherapy Group (Experimental Group) will receive Pegmolesatide treatment throughout the entire 24-week period.
Receives: Drug: The Pegmolesatide Monotherapy Group (Experimental group)
The rHuEPO Monotherapy Group (Control Group)Active comparatorThe rHuEPO Monotherapy Group (Control Group) will be treated with rHuEPO for the first 16 weeks and then switch to Pegmolesatide treatment for the subsequent 8 weeks.
Receives: Drug: The rHuEPO Monotherapy Group (Control Group)
The Pegmolesatide and Roxadustat Combination Therapy Group (Exploratory Group)Active comparatorThe Pegmolesatide and Roxadustat Combination Therapy Group (Exploratory Group) will receive a combination of Pegmolesatide and roxadustat throughout the entire 24-week treatment period.
Receives: Drug: The Pegmolesatide and Roxadustat Combination Therapy Group (Exploratory Group)

What is being measured

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

  1. The change in mean hemoglobin (Hb) levels from baseline at weeks 12 to 16 of treatment in the three groups.

    Primary efficacy endpoints

    Measured: During weeks 12 to 16 of the study treatment

Secondary outcomes (15)

  1. The proportion of participants in the three groups with mean Hb levels ≥100 g/L and ≤120 g/L at weeks 12 to 16 and weeks 20 to 24 of treatment.

    secondary efficacy endpoints

    Measured: During weeks 12 to 16 and weeks 20 to 24 of the study treatment

  2. The proportion of participants in the three groups with mean Hb levels ≥110 g/L and ≤130 g/L at weeks 12 to 16 and weeks 20 to 24 of treatment.

    secondary efficacy endpoints

    Measured: During weeks 12 to 16 and weeks 20 to 24 of the study treatment

  3. The proportion of participants in the three groups with mean Hb levels ≥100 g/L at weeks 12 to 16 and weeks 20 to 24 of treatment.

    secondary efficacy endpoints

    Measured: During weeks 12 to 16 and weeks 20 to 24 of the study treatment

  4. The proportion of participants in the three groups with mean Hb levels ≥110 g/L at weeks 12 and 24 of treatment.

    secondary efficacy endpoints

    Measured: at weeks 12 and 24 of treatment.

  5. The median time to first reach the target Hb level (110-130 g/L) during the treatment period in the three groups.

    secondary efficacy endpoints

    Measured: up to 24 weeks

  6. The absolute values of hemoglobin (Hb) levels during the treatment period in the three groups.

    secondary efficacy endpoints

    Measured: up to 24 weeks

  7. The absolute values of changes in hemoglobin (Hb) levels from baseline during the treatment period in the three groups.

    secondary efficacy endpoints

    Measured: up to 24 weeks

  8. The absolute values of red blood cell (RBC) count levels during the treatment period in the three groups.

    secondary efficacy endpoints

    Measured: up to 24 weeks

  9. The absolute values of hematocrit levels during the treatment period in the three groups.

    secondary efficacy endpoints

    Measured: up to 24 weeks

  10. The dosage of the study drug used between each pair of consecutive follow-up visits during the treatment period in the three groups.

    secondary efficacy endpoints

    Measured: up to 24 weeks

  11. The average dosage of the study drug used by participants with Hb levels within the target range (100 g/L ≤ Hb ≤ 120 g/L) at each follow-up visit during the treatment period in the three groups.

    secondary efficacy endpoints

    Measured: up to 24 weeks

  12. The average dosage of the study drug used by participants with Hb levels within the target range (110 g/L ≤ Hb ≤ 130 g/L) at each follow-up visit during the treatment period in the three groups.

    secondary efficacy endpoints

    Measured: up to 24 weeks

  13. The total number of dosage adjustments at weeks 12 and 24 in the three groups.

    secondary efficacy endpoints

    Measured: At weeks 12 and 16 of the study treatment

  14. The rate of Hb increase during the first 4 weeks and first 8 weeks of treatment in the three groups.

    secondary efficacy endpoints

    Measured: during the first 4 weeks and first 8 weeks of treatment in the three groups.

  15. The proportion of participants receiving rescue therapy during the treatment period in the three groups.

    secondary efficacy endpoints

    Measured: up to 24 weeks

Timeline

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

  1. First posted1 Jul 2025
  2. Study start1 Aug 2025
  3. Primary completion30 Dec 2027 (estimated)
  4. Study completion30 Dec 2028 (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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07045155
Sponsor's protocol ID
HS-20039-404
Acronym
PANGU-stepup
Status last verified
Sep 2025
First submitted
4 Jun 2025
Last updated
12 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Plan for Public Disclosure of Study Protocol and Statistical Analysis Plan: 1. Timing of Disclosure: The study protocol and statistical analysis plan will be disclosed during or after the completion of the trial (the specific timing will be determined by the researchers). 2. Method or Channel for Sharing: The documents can be obtained by contacting the researchers directly. 3. Ethical Considerations: All shared materials must be approved by the ethics committee. No personal information of the participants will be disclosed.

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

  • 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 4 study testing The Pegmolesatide and Roxadustat Combination Therapy Group (Exploratory Group) and The Pegmolesatide Monotherapy Group (Experimental group) in people with Dialysis; Complications and Chronic Kidney Disease 5D, run by Chinese PLA General Hospital 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 10 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: looking for participants now, as of the sponsor's last update on 12 Sep 2025. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ping Li, M.D. (+8615810136659, liping.8@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change in mean hemoglobin (Hb) levels from baseline at weeks 12 to 16 of treatment in the three groups. (time frame: During weeks 12 to 16 of the study treatment). 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 NCT07045155, which also lists 2 linked publications.

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 12 Sep 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in