Evaluate the Efficacy and Safety of HIF-PHI for the Treatment of Anemia and Risks of Cardiovascular and Cerebrovascular Events in ESRD Newly Initiated Dialysis Patients

NCT04134026 | Unknown Phase 4 DMC

• 1 other identifier: CSU-SXH-CT-2019-015
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determin whether HIF-PHI is safe and effective in the treatment of anemia and meanwhile reduces the risk of cardiovascular and cerebrovascular events in patients who have just initiated dialysis.

Conditions

Anemia in Incident Dialysis Patients

Outcome Measures

Primary Outcomes (3)

• Mean Hemoglobin (Hb) change from baseline to average levels from Week 28 to Week 52.

  For participants who did not have an available Hb value during the week 28-52 period, imputation rules were applied.

  Minimum of 52 weeks and maximum of up to 3 years after last subject is randomized

• Proportion of subjects who achieve a Hb response during the first 24 weeks of treatment.

  A Hb response is defined as: Hb ≥11.0g/dL and a Hb increase from baseline by ≥1.0g/dL in subjects whose baseline Hb \>8.0g/dL, or Increase in Hb ≥2.0g/dL in subjects whose baseline Hb ≤8.0g/dL.

  Week 0 to Week 24

• The incidence of cardiovascular and cerebrovascular events within 52 weeks.

  Non fatal myocardial infarction, unstable angina, coronary artery bypass, coronary or peripheral vascular intervention, hospitalization due to heart failure, transient ischemic attack, stroke and death.

  Week 0 to Week 52

Secondary Outcomes (12)

• All cause mortality

  Minimum of 52 weeks and maximum of up to 3 years after last subject is randomized

• BP effect 1: the proportion of subjects with increased hypertension

  Week 0 to Week 27

• BP effect 2

  Week 28 to Week 52

• The change of left ventricular structure

  Weeks 12, 36, 52

• The change of left ventricular systolic function

  Weeks 12, 36, 52

Other Outcomes (1)

• Serum iron level

  Week 0 to Week 27

Study Arms (2)

HIF-PHI

EXPERIMENTAL

HIF-PHI will be dosed orally three times a week.

Drug: HIF-PHI

Epoetin alfa

ACTIVE COMPARATOR

Epoetin alfa wull be disoensed per the package insert or the country-specific product labeling.

Drug: Epoetin Alfa

Interventions

HIF-PHI DRUG

Drug will be dosed orally three times a week.

HIF-PHI

Epoetin Alfa DRUG

The drug will be dispensed per the package insert or the country-specific product labeling.

Also known as: Epogen

Epoetin alfa

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient or his/her legal guardian signs the informed consent
• Age ≥18 years
• Weight: 45-100 kg (included)
• Patients with CKD end-stage renal disease received hemodialysis treatment ≤ 4 weeks, dialysis frequency was stable, kt / V ≥ 1.2, and planned to continue dialysis treatment during the study period
• No iron deficiency.
• No folate or Vitamin B12 deficiency.
• No abnormal liver tests.
• During the screening period, value of Hb is less than 10. 0 g / dl.

You may not qualify if:

• Evidence of any clinically significant infection or active potential infection;
• Active hepatitis or any of the following abnormalities (ALT ≥ 2 times the upper limit of normal value, AST ≥ 2 times the upper limit of normal value, DBIL ≥ 2 times the upper limit of normal value);
• Patients with severe cardiovascular disease have had myocardial infarction, coronary artery bypass or PCI operation within 3 months prior to participating in the study.
• Patients have experienced severe cerebrovascular diseases within 3 months prior to participating in the study: stroke; obvious neurological dysfunction after stroke;
• Patients with active gastrointestinal bleeding occurred within 3 months prior to participating in the study.
• Poor control of hypertension determined by the researchers;
• Previous or current malignancies (except for excised non melanoma skin cancer and carcinoma in situ);
• It is known to have blood system diseases (including congenital and postnatal diseases, such as thalassemia, Fanconi anemia, aplastic anemia, myelodysplastic syndrome, hemolytic anemia, coagulation dysfunction, etc.) or other causes of anemia (such as fecal occult blood positive gastrointestinal hemorrhage or hookworm disease, etc.) ;
• Known autoimmune diseases (such as rheumatoid arthritis, systemic lupus erythematosus, anti neutrophil cytoplasmic antibody associated vasculitis, etc.);
• Any previous functional organ transplant or scheduled organ transplant or no kidney.
• Elective surgery that is expected to result in significant blood loss during the study period.
• Serum albumin \< 25 g / L;
• Within 8 weeks before administration on the first day, the patients were treated with androgen, deferoxamine, deferrone or deferestrol.
• Life expectancy \< 12 months;
• Transfusion within 4 weeks before administration on day 1, or is expected.

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University: lead

Study Sites (1)

Department of Nephrology, Second Xiangya Hospital, Central South University

Changsha, Hunan, 410000, China

Location

Related Publications (1)

• Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.

  PMID: 36005278 DERIVED

MeSH Terms

Interventions

Epoetin Alfa

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Nephrology

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 21, 2019
• Study Start: October 20, 2022
• Primary Completion: October 19, 2023
• Study Completion: October 19, 2024
• Last Updated: May 25, 2021

Record last verified: 2021-05

Locations

CN (1)