Clinical trial for Renal Anemia of Chronic Kidney Disease
Official title A Study of Pegmolesatide of in Dialysis Chronic Kidney Disease (CKD) Patients With Anemia Treated With Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor (HIF-PHI)
ClinicalTrials.gov ID: NCT07136792
What this study is testing
What is Pegmolesatide 2mg SC?
Pegmolesatide 2mg SC is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for renal anemia of chronic kidney disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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...
You likely can't join if
- Known autoimmune diseases, hematologic disorders (including congenital and acquired conditions such as thalassemia, Fanconi anemia, pure red cell...
- 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...
See the full eligibility criteria
- 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...
- 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...
- 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.
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Longyan, Fujian, China
- Zhangzhou, Fujian, China
- Guangzhou, Guangdong, China
- Meizhou, Guangdong, China
- Shantou, Guangdong, China
- Shaoguan, Guangdong, China
- Zhongshan, Guangdong, China
- Zunyi, Guizhou, China
- Jingmen, Hubei, China
- Shiyan, Hubei, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Nantong, Jiangsu, China
- Shenyang, Liaoning, China
- Baotou, Neimenggu, China
- Jinan, Shandong, China
- Yibin, Sichuan, China
- Tianjin, Tianjin Municipality, China
- Hangzhou, Zhejiang, China
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Longyan, Fujian, China; Zhangzhou, Fujian, China; Guangzhou, Guangdong, China; Meizhou, Guangdong, China; Shantou, Guangdong, China and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.