What is the protocol for managing iron deficiency in patients with Chronic Kidney Disease (CKD)?

Protocol for Managing Iron Deficiency in Chronic Kidney Disease

For patients with CKD, IV iron should be administered when TSAT is ≤30% and ferritin is ≤500 ng/mL, with the goal of increasing hemoglobin without starting ESA therapy or decreasing ESA dose requirements. 1

Initial Assessment and Diagnostic Criteria

Iron Status Parameters

• Definition of iron deficiency in CKD:
  • Absolute iron deficiency: TSAT ≤20% and ferritin ≤100 ng/mL in non-dialysis CKD or ≤200 ng/mL in hemodialysis patients 2
  • Functional iron deficiency: TSAT ≤20% with elevated ferritin levels 2

Monitoring Frequency

• Evaluate iron status (TSAT and ferritin) at least every 3 months during ESA therapy 3
• Test more frequently when:
  • Initiating or increasing ESA dose
  • After blood loss events
  • When monitoring response after iron therapy
  • When iron stores may become depleted 3

Treatment Algorithm

Step 1: Non-Dialysis CKD Patients

1. Initial approach:

   • Trial of oral iron for 1-3 months 3
   • Standard dose: One tablet daily of ferrous sulfate, fumarate, or gluconate 3
   • If not tolerated: Reduce to one tablet every other day or consider IV iron 3

2. Switch to IV iron if:

   • Poor response to oral iron after 1-3 months
   • Intolerance to oral iron
   • Poor compliance
   • Severe iron deficiency requiring rapid repletion 3, 1

Step 2: Hemodialysis CKD Patients

1. Preferred approach: IV iron administration 3, 2

   • Recommended due to:
     • Lower intestinal iron absorption in hemodialysis patients
     • Greater iron losses
     • Higher iron requirements with ESA therapy 4

2. Dosing protocol:

   • Initial course: 100-125 mg IV iron weekly for 8-10 weeks 3
   • If TSAT remains <20% and/or ferritin <100 ng/mL, administer another course 3
   • Maintenance dose: 25-125 mg IV iron weekly once target levels achieved 3

Step 3: Target Iron Parameters

• Target levels:

  • TSAT >20% (minimum) and up to 30% 3, 1
  • Ferritin >100 ng/mL (minimum) and up to 500 ng/mL 3, 1

• Upper limits (withhold iron if exceeded):

  • TSAT >50%
  • Ferritin >800 ng/mL 3

Special Considerations

ESA Therapy and Iron

• Address iron deficiency before initiating ESA therapy 3, 5
• For patients on ESA therapy:
  • Evaluate iron status before and during treatment 5, 6
  • Administer supplemental iron when serum ferritin <100 mcg/L or TSAT <20% 5
  • The majority of CKD patients will require supplemental iron during ESA therapy 5, 6

Safety Precautions

• Monitor patients for 60 minutes after initial IV iron infusion 3
• Ensure resuscitative facilities and trained personnel are available 3
• IV iron dextran requires more stringent monitoring (1B recommendation) compared to non-dextran iron (2C recommendation) 3

Efficacy Considerations

• IV iron is superior to oral iron in hemodialysis patients 7
• For non-dialysis CKD, IV iron shows a small but significant advantage in hemoglobin response compared to oral iron 7
• Ferric carboxymaltose can be rapidly administered in high doses and shows better efficacy and tolerability than oral iron in non-dialysis CKD patients 8

Potential Risks and Monitoring

• Balance benefits against potential risks of IV iron therapy 3, 1
• Some evidence suggests increased risk of serious adverse events with IV iron in non-dialysis CKD patients, including cardiovascular events and infections 9
• Monitor hemoglobin response in the first 4 weeks of oral iron therapy 3
• Continue iron therapy for approximately 3 months after normalization of hemoglobin to ensure adequate replenishment of marrow iron stores 3

This protocol provides a structured approach to managing iron deficiency in CKD patients, balancing the need for effective anemia management with safety considerations.