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Pegmolesatide Treatment for Anemia in Patients Undergoing Long-term Dialysis

Study acronym: PANGU-stepup
StatusRecruiting
PhasePhase 4
Started2025-08-01
View on ClinicalTrials.gov ↗

Amendment history

2025-09-08
Not Yet Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations, References v2
Trial statusNot Yet Recruiting→Recruiting
Eligibility criteria-327 characters
[...] er. Body weight ≥40 kg and body mass index (BMI) ≥18 kg/m². DiagnosedSubjects withwho chronichave kidney disease (CKD) stage 5 for ≥12 months, and has been onreceived hemodialysis or peritoneal dialysis for ≥3 months prior to enrollment.; HasSubjects who have been receiving rHuEPOerythropoiesis-stimulating treatmentagents (ESAs) for at least ≥4 weeks beforeprior to randomization, with an average weekly dose of >6000 IU overin the pastlast 4 weeks (equivalent dose converted to short-acting EPO >6000 IU, calculated as: the total rHuEPOamount doseof overshort-acting theEPO pastused 4 weeks/4), an [...] [...]
Study sitesdetails revised at 1 of 1 site
Publicationsdetails revised at 2 of 2 entries
2025-07-02
Study Status, Outcome Measures v1
Re-verified, no change to tracked fields
2025-06-22
Original filing
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. After enrollment, participants will be randomly assigned in a 1:1:1 ratio to the experimental group, control group, and exploratory group. The study will involve a 24-week treatment and observation period, divided into three phases: a screening period (Day -28 to Day -1), a treatment period (Week 0 to Week 16), and an extension period (Week 17 to Week 24). The primary objective is to assess the impact of the three treatment regimens on the hemoglobin levels of patients with DD-CKD anemia.
Trial Details
NCT Number NCT07045155
Lead Sponsor Chinese PLA General Hospital
Collaborators: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Conditions Dialysis; Complications, Chronic Kidney Disease 5D, Renal Anemia of Chronic Kidney Disease, Renal Anaemia, Renal Anemia, Chronic
Enrollment 240 participants
Start Date 2025-08-01
Primary Completion 2027-12-30 (estimated)
Study Completion 2028-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-09-12