A Non-Inferiority, Randomized controlled trial of Alternate-Day versus Multiple-Daily-Dose Oral Iron for Iron Deficiency Anemia in Patients with Non-Dialysis Chronic Kidney Disease

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260721005

Enrollment

Registered

2026-07-21

Start date

2026-07-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Iron deficiency anemia in patients with CKD stage III to V. iron deificiency anemia, chronic kidney disease

Interventions

ferrous umarate (200) 3*1 PO OD Monday Wednesday and Friday (9 tablets/week),ferrous umarate (200) 1*3 PO daily (21 tablets/week)

Active Comparator Drug,Active Comparator Drug

Alternate-Day Oral Iron,Multiple-Daily-Dose Oral Iron

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with chronic kidney disease (CKD) stages 3 to 5 with an estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m2 who have not yet initiated kidney replacement therapy (KRT). 2. Hemoglobin less than 12 g/dL in females and less than 13 g/dL in males. 3. Serum ferritin less than 100 ng/mL (micrograms/L) and transferrin saturation (TSAT) less than 40 percent, or serum ferritin 100 to 300 ng/mL (micrograms/L) and TSAT less than 25 percent. 4. Age 18 years or older.

Exclusion criteria

Exclusion criteria: 1. Patients with hematologic disorders or conditions causing pre-existing anemia, including thalassemia (confirmed by hemoglobin typing), hemolytic anemia, bone marrow disorders, or liver cirrhosis (Child-Pugh score 9 or higher). 2. Patients with other inflammatory conditions associated with anemia, including active malignancy or active autoimmune disease. 3. Patients with diseases or conditions associated with impaired nutrient absorption, including inflammatory bowel disease or short bowel syndrome. 4. Hemoglobin less than 7 g/dL. 5. History of blood transfusion within the previous 1 month, iron therapy within the previous 3 months, or erythropoiesis-stimulating agent (ESA) therapy within the previous 1 month. 6. Active bleeding that has not been controlled. 7. Pregnant or breastfeeding women. 8. History of hypersensitivity to iron preparations. 9. Patients expected to require kidney replacement therapy within 3 months.

Design outcomes

Primary

Measure	Time frame
Comparison of the proportion of patients who achieve successful treatment of iron deficiency anemia. 12 weeks Hemoglobin level	—

Secondary

Measure	Time frame
Comparison of Hb change at 4 weeks 4 weeks Hemoglobin level	—

Countries

Thailand

Contacts

Public ContactThananya Achakornlak

Faculty of Medicine Vajira Hospital Navamindradhiraj University

mhaitheswax@gmail.com0832727777

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026