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A Study of Pegmolesatide of in Dialysis Chronic Kidney Disease (CKD) Patients With Anemia Treated With Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor (HIF-PHI)

NCT07136792 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-01-15

No results posted yet for this study

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.

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.

Conditions

  • Renal Anemia of Chronic Kidney Disease

Interventions

DRUG

Pegmolesatide 2mg SC

All patients will receive pegmolesatide 2mg subcutaneously once every 4 weeks.

DRUG

Pegmolesatide 4mg SC

All patients will receive pegmolesatide 4mg subcutaneously once every 4 weeks.

DRUG

Pegmolesatide 4mg SC

All patients will receive pegmolesatide 4mg subcutaneously once every 4 weeks.

DRUG

Pegmolesatide 6mg SC

All patients will receive pegmolesatide 6mg subcutaneously once every 4 weeks.

Sponsors & Collaborators

  • Guangdong Provincial People's Hospital

    lead OTHER

Principal Investigators

  • Xueqing Yu · Guangdong Provincial People's Hospital

  • Zhiming Ye · Guangdong Provincial People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-08
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07136792 on ClinicalTrials.gov