New hope for dialysis patients: Long-Acting anemia drug under study
NCT ID NCT07136792
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new long-acting drug called pegmolesatide for anemia in people with chronic kidney disease who are on dialysis. It aims to see if switching from current anemia treatments to this drug is safe and effective. About 96 adults will receive the drug for 12 weeks and be followed for 16 weeks.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 96 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Sep 2025
- Expected to finish
-
Dec 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age between 18-75 years, regardless of gender; 2. Body weight ≥ 45 kg, and body mass index (BMI) ≥ 18.5 kg/m²; 3. 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; 4. An up to standard dialysis adequacy testing result before randomization: spKt/V ≥ 1.2 for hemodialysis, Kt/V ≥ 1.7 for peritoneal dialysis; 5. Roxadustat dose ≤ 360 mg/week within 4 weeks before randomization, with stable dose; \[Stable dose is defined as: (the maximum weekly dose within 4 weeks before randomization - the average weekly dose within 4 weeks before randomization) ÷ the maximum weekly dose within 4 weeks before randomization ≤ 30%\]; 6. 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; 7. 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; 8. Understanding of the study procedures and voluntary signing of the written informed consent form. Exclusion Criteria: 1. 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). 2. Confirmed diagnosis of acquired immunodeficiency syndrome (AIDS), syphilis, or tuberculosis and currently undergoing treatment. 3. Known allergy to iron agents or polyethylene glycol molecules. 4. Treatment history with ESAs in combination with HIF-PHIs drugs within 8 weeks prior to randomization. 5. Underwent red blood cell or whole blood transfusion within 12 weeks prior to randomization. 6. 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). 7. 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). 8. Participants judged by the investigator to have uncontrolled or symptomatic secondary hyperparathyroidism, or those with blood iPTH \> 800 pg/mL during the screening period. 9. C-reactive protein ≥ 30 mg/L during the screening period. 10. Cardiac function assessed as NYHA Class III or IV during the screening period. 11. Pregnant or breastfeeding women, or those planning to become pregnant during the study period. 12. 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. 13. Participants deemed by the investigator to have any other factors that make them unsuitable for participation in this trial.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Renal anemia of chronic kidney disease are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
24 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Affiliated Hospital of Zunyi Medical University
NOT_YET_RECRUITINGZunyi, Guizhou, China
-
Beijing Hospital
NOT_YET_RECRUITINGBeijing, Beijing Municipality, China
-
CNPG Dongfeng General Hospital
NOT_YET_RECRUITINGShiyan, Hubei, China
-
Changsha Central Hospital
NOT_YET_RECRUITINGChangsha, Hunan, China
-
Guangdong Provincial People's Hospital
NOT_YET_RECRUITINGGuangzhou, Guangdong, 510080, China
-
Hangzhou Xiaoshan First People's Hospital
NOT_YET_RECRUITINGHangzhou, Zhejiang, China
-
Jingmen Central Hospital
NOT_YET_RECRUITINGJingmen, Hubei, China
-
Longyan First Hospital
NOT_YET_RECRUITINGLongyan, Fujian, China
-
Meizhou People's Hospital
NOT_YET_RECRUITINGMeizhou, Guangdong, China
-
Nantong First People's Hospital
NOT_YET_RECRUITINGNantong, Jiangsu, China
-
Rui'an People's Hospital
NOT_YET_RECRUITINGWenzhou, Zhejiang, China
-
The Affiliated People's Hospital of Ningbo University
NOT_YET_RECRUITINGNingbo, Zhejiang, China
-
The First Affiliated Hospital of Baotou Medical College
NOT_YET_RECRUITINGBaotou, Neimenggu, China
-
The First Affiliated Hospital of Guangzhou Medical University
NOT_YET_RECRUITINGGuangzhou, Guangdong, China
-
The First Affiliated Hospital of Shandong First Medical University
NOT_YET_RECRUITINGJinan, Shandong, China
-
The First Affiliated Hospital of Shantou University Medical College
NOT_YET_RECRUITINGShantou, Guangdong, China
-
The First Hospital of China Medical University
NOT_YET_RECRUITINGShenyang, Liaoning, China
-
Tianjin First Center Hospital
NOT_YET_RECRUITINGTianjin, Tianjin Municipality, China
-
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
RECRUITINGWuhan, Hubei, China
-
Wuhan Fourth Hospital
NOT_YET_RECRUITINGWuhan, Hubei, China
-
Yibin First People's Hospital
NOT_YET_RECRUITINGYibin, Sichuan, China
-
Yuebei People's Hospital
NOT_YET_RECRUITINGShaoguan, Guangdong, China
-
Zhangzhou Municipal Hospital of Fujian Province
NOT_YET_RECRUITINGZhangzhou, Fujian, China
-
Zhongshan Hospital of Traditional Chinese Medicine
NOT_YET_RECRUITINGZhongshan, Guangdong, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.