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.
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.
24 sites in 1 country
China24 sites, 24 recruiting
- Not yet 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
- Recruiting
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei
Gang Xu
- Not yet 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
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.
- Conditions
- Renal Anemia of Chronic Kidney Disease
- 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 group | Role | What they receive |
|---|---|---|
| Arm A1: Pegmolesatide 2mg SC | Experimental | All 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 SC | Experimental | All 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 SC | Experimental | All 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 SC | Experimental | All 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.
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)
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
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
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
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
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
Average drug dose at each follow-up
Measured: From baseline to 4 weeks, 8 weeks,12 weeks and 16 weeks
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.
- First posted22 Aug 2025
- Study start8 Sep 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Anemia of Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, XueQing Yu, Guangdong Provincial People's Hospital
- Investigators
- Xueqing Yu, Study chair, Guangdong Provincial People's HospitalZhiming Ye, Study director, Guangdong Provincial People's Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07136792
- Acronym / sponsor ID
- KY2025-667-03
- Conditions
- Renal Anemia of Chronic Kidney Disease
- Keywords
- Renal Anemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A1: Pegmolesatide 2mg SC | Experimental | Drug: Pegmolesatide 2mg SCAll patients in low-dose Roxadustat cohort randomised into this group will receive pegmolesatide 2mg subcutaneously once every 4 weeks. |
| Arm A2: Pegmolesatide 4mg SC | Experimental | Drug: Pegmolesatide 4mg SCAll patients in low-dose Roxadustat cohort randomised into this group will receive pegmolesatide 4mg subcutaneously once every 4 weeks. |
| Arm B1: Pegmolesatide 4mg SC | Experimental | Drug: Pegmolesatide 4mg SCAll patients in high-dose Roxadustat cohort randomised into this group will receive pegmolesatide 4mg subcutaneously once every 4 weeks. |
| Arm B2: Pegmolesatide 6mg SC | Experimental | Drug: Pegmolesatide 6mg SCAll patients in high-dose Roxadustat cohort randomised into this group will receive pegmolesatide 6mg subcutaneously once every 4 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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%];
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pegmolesatide 2mg SCAll patients will receive pegmolesatide 2mg subcutaneously once every 4 weeks. | Drug | Arm A1: Pegmolesatide 2mg SC |
| Pegmolesatide 4mg SCAll patients will receive pegmolesatide 4mg subcutaneously once every 4 weeks. | Drug | Arm A2: Pegmolesatide 4mg SC |
| Pegmolesatide 4mg SCAll patients will receive pegmolesatide 4mg subcutaneously once every 4 weeks. | Drug | Arm B1: Pegmolesatide 4mg SC |
| Pegmolesatide 6mg SCAll patients will receive pegmolesatide 6mg subcutaneously once every 4 weeks. | Drug | Arm B2: Pegmolesatide 6mg SC |
Primary outcome
Change of mean HB level
Time frame: from baseline to 12 weeks and 16 weeks
Change of mean HB level from baseline to 12 weeks and 16 weeks
7 secondary outcomes
Change of mean HB level
Time frame: from baseline to 12 weeks and 16 weeks
Changes in red blood cell count
Time frame: from baseline to 4 weeks, 8 weeks, 12 weeks, 16 weeks
Median time to the first HB value reaching 10.0-12.0 g/dl
Time frame: From baseline to 4 weeks, 8 weeks,12 weeks and 16 weeks
Proportion of patients with HB 10.0-12.0 g/dl
Time frame: from baseline to 4 weeks, 8 weeks,12 weeks and 16 weeks
Proportion of patients with HB 11.0-13.0 g/dl
Time frame: from baseline to 4 weeks, 8 weeks, 12 weeks and 16 weeks
Average drug dose at each follow-up
Time frame: From baseline to 4 weeks, 8 weeks,12 weeks and 16 weeks
Adverse Events
Time frame: From the start of study drug to 30 days after the last dose of study drug
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xueqing Yu study chair
Guangdong Provincial People's Hospital
Zhiming Ye study director
Guangdong Provincial People's Hospital
24 sites in 1 country: see every site and its status.
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?
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; AzTrials last refreshed its copy on 8 Nov 2026.