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Renal Anemia of Chronic Kidney DiseaseNCT07136792

A Study of Pegmolesatide of in Dialysis Chronic Kidney Disease (CKD) Patients With Anemia Treated With Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor (HIF-PHI)

A study testing Pegmolesatide 2mg SC, Pegmolesatide 4mg SC and Pegmolesatide 6mg SC in people with Renal Anemia of Chronic Kidney Disease, run by Guangdong Provincial People's Hospital at 24 sites 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

For patients with renal anemia treated with hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), there is a clinical need of switching to long-acting and safe medications. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Renal Anemia of Chronic Kidney Disease
What is being tested?
Pegmolesatide 2mg SC, Pegmolesatide 4mg SC and Pegmolesatide 6mg SC
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
24 sitesChina
Study dates
8 Sep 2025to Dec 2027
Phase
Interventional
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 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age between 18-75 years, regardless of gender;
  • Body weight ≥ 45 kg, and body mass index (BMI) ≥ 18.5 kg/m²;
  • Diagnosis of chronic renal failure, and having undergone a stable regimen of peritoneal dialysis or hemodialysis for at least 12 weeks prior to enrollment (with stable hemofiltration at a frequency of every 2 or 4 weeks if applicable). Stable dialysis frequency and no plans to change the dialysis modality during the trial;
  • An up to standard dialysis adequacy testing result before randomization: spKt/V ≥ 1.2 for hemodialysis, Kt/V ≥ 1.7 for peritoneal dialysis;
  • Roxadustat dose ≤ 360 mg/week within 4 weeks before randomization, with stable dose; [Stable dose is defined as: (the maximum weekly dose within 4 weeks before randomization - the average weekly dose within 4 weeks before randomization) ÷ the maximum weekly dose within 4 weeks before randomization ≤ 30%];
  • Two pre-dialysis HB test values within 4 weeks before randomization of 8.0 - 12.0 g/dl, with an absolute difference between the two Hb values ≤ 1.3 g/dl, and an interval of ≥ 7 days between the two HB tests;
  • Serum ferritin level ≥ 100 μg/L and transferrin saturation (TAST) ≥ 20% at the time of testing before randomization, serum folate ≥ the lower limit of normal, and vitamin B12 ≥ the lower limit of normal;
  • Understanding of the study procedures and voluntary signing of the written informed consent form.

Who cannot join

  • Known autoimmune diseases, hematologic disorders (including congenital and acquired conditions such as thalassemia, Fanconi anemia, pure red cell aplasia, myelodysplastic syndrome, hemolytic anemia, and coagulation disorders), or other causes of anemia apart from CKD (such as gastrointestinal bleeding or hookworm disease).
  • Confirmed diagnosis of acquired immunodeficiency syndrome (AIDS), syphilis, or tuberculosis and currently undergoing treatment.
  • Known allergy to iron agents or polyethylene glycol molecules.
  • Treatment history with ESAs in combination with HIF-PHIs drugs within 8 weeks prior to randomization.
  • Underwent red blood cell or whole blood transfusion within 12 weeks prior to randomization.
  • Poorly controlled blood pressure (uncontrolled hypertension is defined as: during the screening period, systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg in two or more blood pressure measurements, or although the blood pressure values are below the aforementioned criteria, the investigator deems it necessary to adjust antihypertensive medications).
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  • Active hepatitis or any of the following abnormal test results during the screening period (ALT ≥ 2 times the upper limit of normal, AST ≥ 2 times the upper limit of normal, DBIL ≥ 2 times the upper limit of normal, serum albumin < 2.5 g/dl).
  • Participants judged by the investigator to have uncontrolled or symptomatic secondary hyperparathyroidism, or those with blood iPTH > 800 pg/mL during the screening period.
  • C-reactive protein ≥ 30 mg/L during the screening period.
  • Cardiac function assessed as NYHA Class III or IV during the screening period.
  • Pregnant or breastfeeding women, or those planning to become pregnant during the study period.
  • Participants who plan to undergo kidney transplantation during the trial period or have already been kidney donors, or those who plan to undergo elective surgery during the trial period.
  • Participants deemed by the investigator to have any other factors that make them unsuitable for participation in this trial.

Trial locations and contacts

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

Xueqing Yu contact

+86-20-83827812

yuxueqing@gdph.org.cn

Zhiming ye contact

138 2616 1678

yezhiming@gdph.org.cn

24 sites in 1 country

China24 sites, 24 recruiting

  • The First Affiliated Hospital of Baotou Medical College

    Baotou, Neimenggu

    Caili Wang

    Not yet recruiting

  • Beijing Hospital

    Beijing, Beijing Municipality

    Xin Liu

    Not yet recruiting

  • Changsha Central Hospital

    Changsha, Hunan

    Rui Wen

    Not yet recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510080

    Xueqing Yu, +86-20-83827812, yuxueqing@gdph.org.cn

    Zhiming Ye, yezhiming@gdph.org.cn

    Not yet recruiting

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong

    Jie Xiao

    Not yet recruiting

  • Hangzhou Xiaoshan First People's Hospital

    Hangzhou, Zhejiang

    Xiaoyun Zhang

    Not yet recruiting

  • The First Affiliated Hospital of Shandong First Medical University

    Jinan, Shandong

    Xueqing Tang

    Not yet recruiting

  • Jingmen Central Hospital

    Jingmen, Hubei

    Zhengli Quan

    Not yet recruiting

  • Longyan First Hospital

    Longyan, Fujian

    Senchao Wu

    Not yet recruiting

  • Meizhou People's Hospital

    Meizhou, Guangdong

    Shaoqing Xue

    Not yet recruiting

  • Nantong First People's Hospital

    Nantong, Jiangsu

    Lianglan Shen

    Not yet recruiting

  • The Affiliated People's Hospital of Ningbo University

    Ningbo, Zhejiang

    Canxin Zhou

    Not yet recruiting

  • The First Affiliated Hospital of Shantou University Medical College

    Shantou, Guangdong

    Yanqiang Peng

    Not yet recruiting

  • Yuebei People's Hospital

    Shaoguan, Guangdong

    Min He

    Not yet recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning

    Li Yao

    Not yet recruiting

  • CNPG Dongfeng General Hospital

    Shiyan, Hubei

    Huaqian Chen

    Not yet recruiting

  • Tianjin First Center Hospital

    Tianjin, Tianjin Municipality

    Wenxiu Chang

    Not yet recruiting

  • Rui'an People's Hospital

    Wenzhou, Zhejiang

    Zengqi Xue

    Not yet recruiting

  • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei

    Gang Xu

    Recruiting

  • Wuhan Fourth Hospital

    Wuhan, Hubei

    Hua Li

    Not yet recruiting

  • Yibin First People's Hospital

    Yibin, Sichuan

    Wanchao Zhang

    Not yet recruiting

  • Zhangzhou Municipal Hospital of Fujian Province

    Zhangzhou, Fujian

    Shanying Chen

    Not yet recruiting

  • Zhongshan Hospital of Traditional Chinese Medicine

    Zhongshan, Guangdong

    Yanlin Li

    Not yet recruiting

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou

    Xiaoyong Yan

    Not yet recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of Pegmolesatide in Dialysis Chronic Kidney Disease (CKD) Patients With Anemia Treated With Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor (HIF-PHI): a Multi-center, Prospective, Open-label, Randomized Parallel Controlled Trial

For patients with renal anemia treated with hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), there is a clinical need of switching to long-acting and safe medications.

Pegmolesatide, a polyethylene glycol (PEG)-conjugated erythropoiesis-stimulating peptide, is a long-acting erythropoiesis-stimulating agent (ESA) with sustained activity. It was approved for marketing by the National Medical Products Administration (NMPA) in June 2023. Phase III clinical trials have demonstrated its efficacy and safety in dialysis patients with renal anemia who were previously treated with recombinant human erythropoietin (rHuEPO). However, there are currently no data regarding the efficacy and safety of switching from HIF-PHIs to pegmolesatide, and there is a lack of standard for the dose conversion.

Read more

This study is a multi-center, prospective, open-label, randomized parallel-controlled clinical trial, planning to enroll 96 patients.

All enrolled patients will receive 12 weeks of treatment and be followed up for 16 weeks.

Read the detailed description

For patients with renal anemia treated with HIF-PHIs, there is a clinical need of switching to long-acting and safe medications.

Pegmolesatide, a polyethylene glycol (PEG)-conjugated erythropoiesis-stimulating peptide, is a long-acting erythropoiesis-stimulating agent (ESA) with sustained activity. It was approved for marketing by the National Medical Products Administration (NMPA) in June 2023. Phase III clinical trials have demonstrated its efficacy and safety in dialysis patients with renal anemia who were previously treated with recombinant human erythropoietin (rHuEPO). However, there are currently no data regarding the efficacy and safety of switching from HIF-PHIs to pegmolesatide, and there is a lack of standard for the dose conversion.

This study is a multi-center, prospective, open-label, randomized parallel-controlled clinical trial, planning to enroll 96 patients.

Based on the weekly dose of Roxadustat before randomization, patients are divided into two cohorts: the low-dose Roxadustat cohort (weekly dose ≤210 mg) and the high-dose Roxadustat cohort (weekly dose >210 mg and ≤360 mg), with 48 patients in each cohort. Each cohort is stratified by hemoglobin (HB) level, with a 1:1 ratio for HB <10.0 g/dl and HB ≥10.0 g/dl, meaning that there are 24 patients in both cohorts.

Within each cohort, patients are randomly assigned to 2 groups at a 1:1 ratio based on the initial treatment dose of pegmolesatide. Specifically, the patients in low-dose Roxadustat cohort are randomized into the Pegmolesatide initial dose 2 mg group or 4 mg group; the patients in high-dose Roxadustat cohort are randomized into the Pegmolesatide initial dose 4 mg group or 6 mg group, with 24 patients in each group entering the trial period. Pegmolesatide is administered subcutaneously once every 4 weeks, and the dosage is adjusted according to the drug's instructions for use. All enrolled patients will receive 12 weeks of treatment and be followed up for 16 weeks.

Being tested
Pegmolesatide 2mg SC, Pegmolesatide 4mg SC, Pegmolesatide 6mg SC
Keywords
Renal Anemia

What participants receive

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

  • Pegmolesatide 2mg SCDrug

    All patients will receive pegmolesatide 2mg subcutaneously once every 4 weeks.

  • Pegmolesatide 4mg SCDrug

    All patients will receive pegmolesatide 4mg subcutaneously once every 4 weeks.

  • Pegmolesatide 4mg SCDrug

    All patients will receive pegmolesatide 4mg subcutaneously once every 4 weeks.

  • Pegmolesatide 6mg SCDrug

    All patients will receive pegmolesatide 6mg subcutaneously once every 4 weeks.

Study groups in NCT07136792
Study groupRoleWhat they receive
Arm A1: Pegmolesatide 2mg SCExperimentalAll patients in low-dose Roxadustat cohort randomised into this group will receive pegmolesatide 2mg subcutaneously once every 4 weeks.
Receives: Drug: Pegmolesatide 2mg SC
Arm A2: Pegmolesatide 4mg SCExperimentalAll patients in low-dose Roxadustat cohort randomised into this group will receive pegmolesatide 4mg subcutaneously once every 4 weeks.
Receives: Drug: Pegmolesatide 4mg SC
Arm B1: Pegmolesatide 4mg SCExperimentalAll patients in high-dose Roxadustat cohort randomised into this group will receive pegmolesatide 4mg subcutaneously once every 4 weeks.
Receives: Drug: Pegmolesatide 4mg SC
Arm B2: Pegmolesatide 6mg SCExperimentalAll patients in high-dose Roxadustat cohort randomised into this group will receive pegmolesatide 6mg subcutaneously once every 4 weeks.
Receives: Drug: Pegmolesatide 6mg SC

What is being measured

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

  1. Change of mean HB level

    Change of mean HB level from baseline to 12 weeks and 16 weeks

    Measured: from baseline to 12 weeks and 16 weeks

Secondary outcomes (7)

  1. Change of mean HB level

    Change in mean HB levels from baseline to 12 weeks and 16 weeks, stratified by different baseline HB levels

    Measured: from baseline to 12 weeks and 16 weeks

  2. Changes in red blood cell count

    Changes in red blood cell count from baseline to each follow-up

    Measured: from baseline to 4 weeks, 8 weeks, 12 weeks, 16 weeks

  3. Median time to the first HB value reaching 10.0-12.0 g/dl

    Median time to the first HB value reaching 10.0-12.0 g/dl

    Measured: From baseline to 4 weeks, 8 weeks,12 weeks and 16 weeks

  4. Proportion of patients with HB 10.0-12.0 g/dl

    Proportion of patients with HB 10.0-12.0 g/dl at each follow-up

    Measured: from baseline to 4 weeks, 8 weeks,12 weeks and 16 weeks

  5. Proportion of patients with HB 11.0-13.0 g/dl

    Proportion of patients with HB11.0-13.0 g/dl at each follow-up

    Measured: from baseline to 4 weeks, 8 weeks, 12 weeks and 16 weeks

  6. Average drug dose at each follow-up

    Measured: From baseline to 4 weeks, 8 weeks,12 weeks and 16 weeks

  7. Adverse Events

    Safety of therapy by Investigator.

    Measured: From the start of study drug to 30 days after the last dose of study drug

Timeline

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

  1. First posted22 Aug 2025
  2. Study start8 Sep 2025
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07136792
Sponsor's protocol ID
KY2025-667-03
Status last verified
Jan 2026
First submitted
31 Jul 2025
Last updated
15 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Pegmolesatide 2mg SC, Pegmolesatide 4mg SC and Pegmolesatide 6mg SC in people with Renal Anemia of Chronic Kidney Disease, run by Guangdong Provincial People's Hospital at 24 sites 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 8 inclusion and 13 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 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites 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.

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 Xueqing Yu (+86-20-83827812, yuxueqing@gdph.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of mean HB level (time frame: from baseline to 12 weeks and 16 weeks). 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 NCT07136792.

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 15 Jan 2026.

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