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A randomized controlled trial of iron supplementation in non-dialysis diabetic nephropathy patients with anemia

A randomized controlled trial of iron supplementation in non-dialysis diabetic nephropathy patients with anemia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095169
Enrollment
Unknown
Registered
2025-01-02
Start date
2025-01-06
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Diabetic nephropathy

Interventions

Experimental group:Take polysaccharide iron complex capsules (Hongyuanda, Shanghai Pharmaceutical Group, Qingdao Guofeng Pharmaceutical Co., Ltd., each capsule contains 150mg of iron), 300mg each time
Control group:None

Sponsors

Yaan People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age>=18 years, non-dialysis diabetic nephropathy patients, estimated glomerular filtration rate (GFR) of 15-90 ml/min/1.73 m2 (calculated by MDRD formula); 2. Presence of renal anemia, hemoglobin (hemoglobinHb) level <=120g/L for women and <=130g/L for men; 3. Ferritin (serumferritin SF) < 500 ng/ml and transferrin saturation (TSAT) < 50%; 4. Not treated with iron or erythropoiesis-stimulating agents (ESAs) in the 8 weeks prior to inclusion.

Exclusion criteria

Exclusion criteria: 1. Anemia and active systemic infection caused by any reason other than iron deficiency in CKD; 2. Intolerance to polysaccharide iron complex or any of its components; 3. Pregnant or lactating; 4. Anticipated possible dialysis or transplantation during the study; 5. Positive fecal occult blood test; 6. Chronic liver disease; 7. Hypertension (systolic blood pressure > 180mmHg or diastolic blood pressure >110mmHg) with New York Heart Association class IV heart failure and poor control; 8. Any malignant tumor (except basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) within the past 3 years; 9. There are events that may affect follow-up, such as the presence of drug or alcohol abuse, severe mental disorders, severe respiratory diseases.

Design outcomes

Primary

MeasureTime frame
Hemoglobin;

Countries

China

Contacts

Public ContactHe Yi

Yaan People's Hospital

heyi0835@qq.com+86 187 2816 8907

Outcome results

None listed

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