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New treatment option for Dialysis; Complications
Official title Pegmolesatide Treatment for Anemia in Patients Undergoing Long-term Dialysis
ClinicalTrials.gov ID: NCT07045155
What this study is testing
What is The rHuEPO Monotherapy Group (Control Group)?
The rHuEPO Monotherapy Group (Control Group) is an investigational medicine, being studied as a potential treatment for dialysis; complications.
Also referred to as Control Group.
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
- 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.
- Phase 4: studies an already-approved treatment
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 80
You may be able to join if
- Aged ≥18 years and ≤80 years, with no restrictions on gender.
- Body weight ≥40 kg and body mass index (BMI) ≥18 kg/m².
- people who have received hemodialysis or peritoneal dialysis for ≥3 months prior to enrollment;
- people who have been receiving erythropoiesis-stimulating agents (ESAs) for ≥4 weeks prior to randomization, with an average weekly dose \>6000 IU in...
- 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;
You likely can't join if
- Known to have active malignancy, polycystic kidney disease, hematologic disorders (including congenital and acquired anemias such as thalassemia...
- Known to have experienced stroke, transient ischemic attack, myocardial infarction, thromboembolic events (deep vein thrombosis), pulmonary embolism...
- 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...
See the full eligibility criteria
- Aged ≥18 years and ≤80 years, with no restrictions on gender.
- Body weight ≥40 kg and body mass index (BMI) ≥18 kg/m².
- people who have received hemodialysis or peritoneal dialysis for ≥3 months prior to enrollment;
- people 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...
- 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).
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
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 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. 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.