Oral Iron in Children With Chronic Kidney Disease (FeTCh-CKD)

Weill Cornell Medicine (WCM)

Status and phase

Enrolling

Phase 4

Conditions

Chronic Kidney Diseases

Chronic Kidney Insufficiency

Treatments

Drug: Ferrous Sulfate

Study type

Interventional

Funder types

Other

Identifiers

NCT03991169

1812019836

Details and patient eligibility

About

This is a pilot clinical trial of oral iron therapy in children with chronic kidney disease (CKD) and mild anemia. Eligible children will be randomized into a standard of care (iron sulfate) arm vs. no iron therapy arm for 3 months. The outcomes will include muscle strength, physical activity, and changes in eating behavior, which will be measured at enrollment and at the end of the study period.

Enrollment

40 estimated patients

Sex

All

Ages

1 to 21 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key inclusion criteria:

Age 1-21 years old (muscle strength will be assessed only in children >3 year old)
Estimated glomerular filtration rate (GFR) < 90 ml/min/1.73m2 by bedside Schwartz formula [height (cm) *0.413 / serum creatinine (mg/dL)]
Hemoglobin (Hb) more or equal than 9.0 at the previous clinic visit
Hb less than 11.5 g/dL in children younger than 5 years Hb less than 12.0 g/dL in children 5-12 years Hb <12.5 g/dL in children 12-15 yrs and females >15 yrs. Hb <13.5 g/dL in males >15 years (all at the previous clinic visit)

Children with transferrin saturation ≤ 20% AND serum ferritin ≤ 100 ng/mL will be randomized into one of the arms

Key exclusion criteria:

Transferrin saturation <5%
Serum ferritin < 10 ng/mL
Iron therapy or erythrocyte stimulating agents (erythropoietin) therapy within 3 months prior to randomization
Blood transfusion within 4 months prior to enrollment
Children on hemodialysis
Rapidly deteriorating kidney function or expectation for transplantation or dialysis in less than 3 months
Pregnancy and breast-feeding