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Protocols of iron supplementation in hemodialysis patients with renal anemia treated with enarodustat: a single-center exploratory randomized controlled study

Protocols of iron supplementation in hemodialysis patients with renal anemia treated with enarodustat: a single-center exploratory randomized controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083227
Enrollment
Unknown
Registered
2024-04-18
Start date
2024-05-01
Completion date
Unknown
Last updated
2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal anemia

Interventions

High-Ferritin :Reactive iron supplementation, maintaining ferritin 400ng/ml
Low-Ferritin :Reactive iron supplementation, maintaining ferritin 100ng/ml
Mid-Ferritin :Reactive iron supplementation, maintaining ferritin 200ng/ml

Sponsors

Department of Nephrology, Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1: Receive regular hemodialysis for more than 6 months 2: Adequate dialysis (=3 times per week and =10 hours/week) 3: Use ESA to treat anemia 4: Ferritin 200~500ng/mL 5: Hb 100~120g/L

Exclusion criteria

Exclusion criteria: 1: Iron allergy or previous inability to receive intravenous iron therapy for any reason 2: rHuEPO dosage >300U/Kg/W or Daepotin a>1.5ug/Kg/W 3: There were significant drug-related adverse reactions during enaldostat induction 4: abnormal liver function 5: Previous diagnosis of any type of myeloproliferative disease 6: History of malignant tumor 7: Untreated proliferative retinopathy with fundus hemorrhage 8: Within 3 months of gastrointestinal bleeding 9: Diagnosis of thrombotic, embolic disease within 3 months 10: Pregnancy or lactation

Design outcomes

Primary

MeasureTime frame
Hb/AAD ;

Secondary

MeasureTime frame
control rates of Hb ;Adverse reactions to intravenous iron ;

Countries

China

Contacts

Public ContactNan Hu

Peking University First Hospital

konan112x@163.com+86 138 1050 8646

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026