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Anemia Management in Pre-Dialysis Chronic Kidney Disease Patients - Adult - Ambulatory [20]

Anemia Management in Pre-Dialysis Chronic Kidney Disease Patients - Adult - Ambulatory [20] - Clinical Hub, UW Health Clinical Tool Search, UW Health Clinical Tool Search, Delegation/Practice Protocols, Ambulatory Delegation Protocols


Delegation Protocol Number: 20

Delegation Protocol Title:
Anemia Management in Pre-Dialysis Chronic Kidney Disease Patients - Adult - Ambulatory

Delegation Protocol Applies To:
UWHC Kidney Clinic’s Anemia Clinic

Target Patient Population:
Patients with Anemia of Chronic Kidney Disease Stage III, IV, or V in whom the purpose of using
erythropoiesis stimulating agents is to avoid the need for red blood cell transfusions.

Delegation Protocol Champion:
R. Allan Jhagroo, MD - Department of Medicine-Nephrology, Medical Director Kidney Clinic
Arjang Djamali, MD - Department of Medicine-Nephrology

Delegation Protocol Reviewer:
Kimberly Holdener, PharmD - Department of Pharmacy

Responsible Departments:
Department of Pharmacy

Purpose Statement:
To delegate authority from the patient’s nephrology provider to the Pharmacists (RPhs) and
Registered Nurses (RNs) practicing at the Kidney Clinic Anemia Clinic to manage the patient’s anemia
therapy including initiation, patient assessment, dose adjustment and monitoring.

Who May Carry Out This Delegation Protocol:
Pharmacists (RPhs) and Registered Nurses (RNs) in the Kidney Clinic’s Anemia Clinic who have
completed training in the use of this protocol and demonstrated competence with an annual
renewal.

Guidelines for Implementation:
1. The protocol may be initiated by a UW Health provider referral to the Anemia Clinic.
2. Initial patient assessment
2.1. All patients referred to the Anemia Clinic will have an initial assessment done by a Kidney
Clinic nurse or pharmacist.
2.2. The patient will qualify for erythropoiesis stimulating agent (ESA) therapy through the
Anemia Clinic if the following criteria are met:
2.2.1. Hemoglobin (Hgb) less than 9.5 g/dL for at least two consecutive measurements
2.2.2. Iron studies are at goal (Ferritin greater than 100 ng/mL and Transferring Saturation
(TSAT) greater than 20%)
2.2.3. Glomerular Filtration Rate (GRF) is less than 60 mL/min/1.73m²
2.2.4. Patient has Medicare or other insurance, is willing to self-pay, or qualifies for a patient
assistance program
2.3. Patients who qualify for ESA therapy will be scheduled for appointments in the Anemia
Clinic.
Copyright © 2017 University of Wisconsin Hospitals and Clinics Authority
Contact: Lee Vermeulen, CCKM@uwhealth.org Last Revised:
 
11/2017CCKM@uwhealth.org

2.4. Patients who do not qualify for ESA therapy, but who qualify for IV iron replacement based
on the criteria below will have IV iron ordered.
2.5. A Kidney Clinic nurse or pharmacist will evaluate the patient and determine appropriate
starting doses for the ESA and iron supplementation based on the dosing guidelines below.
3. Laboratory monitoring
3.1. Hemoglobin (Hgb) – obtain at least monthly by point-of-care monitoring or by venous blood
draw. Obtain at initial visit unless result available during the previous 30 days.
3.1.1. target value = 9.5 – 11 g/dL
3.2. Serum Creatinine - obtain at initial visit unless result available during the previous 30 days.
3.3. Iron, total iron-binding capacity (TIBC), percent saturation (TSAT) and ferritin – obtain at
least every three months. Obtain at initial visit unless result available during the previous 3
months.
3.3.1. target ferritin value > 100 ng/mL
3.3.2. target TSAT value > 20%
4. Blood pressure monitoring
4.1. Blood pressure will be checked at every patient visit.
4.2. If a patient has a systolic blood pressure reading >180 mmHg, the darbepoetin dose will be
held and the provider contacted.
4.3. If a patient has a SBP <180 mmHg but >160 mmHg at 3 consecutive visits, the provider will
be contacted.
5. General procedure for Anemia Clinic visits
5.1. Patients followed in the Anemia Clinic will have the appropriate laboratory tests performed
prior to or during their appointment.
5.2. At each appointment the ESA dose to be administered will be determined based on the
hemoglobin result as outlined below.
5.3. Follow up appointments in Anemia Clinic are made to coincide with when the next ESA dose
is due.
5.4. The designated health care provider will document each encounter in the electronic medical
record as outlined below.
5.5. Patients who self inject ESA’s at home will not be required to come into the Anemia Clinic
for appointments, but will have regular laboratory tests drawn and ESA dosage adjustments
made over the phone according to section 7 below.
6. Initiating and maintaining iron therapy
6.1. Criteria for iron therapy
6.1.1. All patients receiving epoetin or darbepoetin will be started on oral iron unless the
patient dose not tolerate oral iron, TSAT is greater than 50% or ferritin is greater than
800 ng/mL.
6.1.2. An intravenous (IV) iron load is preferred for any patient with a TSAT or ferritin level
below the target value.
6.1.3. Patients who have ferritin between 100 and 800 ng/mL or TSAT 20% to 50% and are
iron deficient based on clinical assessment of patient response to therapy will have a
trial of IV iron.
6.1.4. IV iron will not be administered to patients with a ferritin greater than 800 ng/mL or a
TSAT greater than 50%.
6.1.5. All patients who qualify for IV iron will be screened for active infection. IV iron will not
be administered to patients who have a significant active infection, e.g. bacteremia,
any infection requiring IV antibiotics, draining wounds, pneumonia, and cellulitis, even
if on oral antibiotics. IV iron may be given in the presence of minor infection, e.g.
urinary tract infections requiring short-term (7-10 days) oral antibiotics.
Copyright © 2017 University of Wisconsin Hospitals and Clinics Authority
Contact: Lee Vermeulen, CCKM@uwhealth.org Last Revised:
 
11/2017CCKM@uwhealth.org

6.2. Oral iron supplementation
6.2.1. Replacement dosing of ferrous sulfate 325 mg tablets, 2 to 4 tablets/day as tolerated
will be recommended for patients whose iron studies are not at goal.
6.2.2. Maintenance dosing of ferrous sulfate 325 mg tablets, 1 to 2 tablets/day as tolerated
will be recommended for patients with adequate iron studies.
6.3. Intravenous iron supplementation
6.3.1. Two doses of iron sucrose 500 mg IV each infused over 3 hours.
6.3.2. For patients who do not tolerate doses of 500mg, three doses of iron sucrose 300 mg IV
each infused over 1.5 hours may be ordered.
6.3.3. When iron sucrose is not available or not tolerated, 4 doses of sodium ferric gluconate
250mg IV each infused over 1 hour will be given.
6.3.4. Doses of IV iron may be scheduled between 1 and 7 days apart.
7. Initiation and maintenance of ESAs
7.1. Darbepoetin alfa
7.1.1. Darbepoetin is the preferred ESA for anemia therapy at UW Kidney clinic.
7.1.2. General dosing guidelines
• Dose increases will not occur more than once a month.
• Syringes are available in the following dosages: 25 mcg, 40 mcg, 60 mcg, 100
mcg, 150 mcg, 200 mcg, 300 mcg, 500 mcg. Doses given to patients will use the
entire syringe (no partial wasting of a syringe should occur).
• The current dose will be continued if the Hgb is stable within the target range.
• The maximum dose that may be administered is 500 mcg every 2 weeks.
• Other dosing regimens may be considered based on clinical assessment and the
patient’s response to therapy or per provider request.
7.1.3. Initial dosing
• The starting dose for patients weighing between 50 and 110 kg is 100mcg
subcutaneous every 4 weeks.
• For patients weighing greater than 110 kg starting dose will be 150 mcg every 4
weeks.
• For patients weighing less than 50 kg starting dose will be 60 mcg every 4 weeks.
7.1.4. Dose increases
• Dose increases are made by changing the dose to the next available higher
syringe strength.
• Alternatively a dose increase can be made by shortening the period between
doses. A frequency rather than syringe strength change may be made based on
patient convenience and current dose, e.g. the patient is already receiving a 500
mcg dose.
• A dosage increase will be made if the Hgb is below the goal range and the
increase in Hgb is less than 1 g/dL in a 4 week period.
7.1.5. Dose decreases
• Dose decreases are made by changing the dose to the next lower syringe
strength.
• Alternatively a dose decrease can be made by lengthening the period between
doses.
• A dosage decrease will be made if the Hgb increase is greater than 1.5 g/dL in a 4
week period.
7.1.6. Holding the dose of ESA
• The darbepoetin dose will be held if the Hgb is greater than 11 g/dL.
Copyright © 2017 University of Wisconsin Hospitals and Clinics Authority
Contact: Lee Vermeulen, CCKM@uwhealth.org Last Revised:
 
11/2017CCKM@uwhealth.org

• A follow up Hgb level will be checked in 2 to 4 weeks based on patient
convenience and Hgb trend.
• When the Hgb is less than 11 g/dL the ESA will be resumed at the next dosage
lower than what was being given at the time the medication was held.
7.2. Epoetin alfa
7.2.1. Epoetin alfa may be used in patients who do not tolerate darbepoetin or who do not
have insurance coverage for darbepoetin.
7.2.2. General dosing guidelines
• Doses will be given with a frequency of weekly to every 2 weeks.
• The current dose should be continued if the Hgb is stable within the target range.
• The starting dose is 10,000 units subcutaneous weekly.
7.2.3. Dose increases
• If the Hgb is below the goal range and the increase in Hgb is less than 1 g/dL in a
4 week period increase the dose by 25%.
7.2.4. Dose decreases
• If the Hgb increase is greater than 1.5 g/dL in a 4 week period decrease the dose
by 25%.
7.2.5. Holding the dose of ESA
• The epoetin dose will be held if the Hgb is greater than 11 g/dL.
• A follow up Hgb level will be checked in 2 to 4 weeks based on patient
convenience and Hgb trend.
• When the Hgb is below 11 g/dL the ESA will be resumed at a dosage 25% lower
than what was being given at the time the medication was held.
8. Documentation
8.1. General documentation guidelines
8.1.1. Point-of-care Hgb results must be recorded in the electronic medical record.
8.1.2. Lab results from outside the UW Health system will be sent to medical records for
scanning.
8.1.3. If IV iron is ordered this must be documented in a note stating that the indication is
anemia of Chronic Kidney Disease (CKD) Stage III, IV or V with iron deficiency.
8.2. Initial referral documentation will include the following:
8.2.1. Completion of anemia of CKD patient education
8.2.2. Patient is being treated for anemia of CKD
8.2.3. Stage of CKD
8.2.4. Initial Hgb value
8.2.5. Iron studies results or that iron studies have been ordered
8.2.6. Initiation of iron therapy if indicated
8.2.7. Dose of ESA to be initiated
8.3. Follow-up appointment documentation in the electronic medical record must include the
following:
8.3.1. Patient is being treated for anemia of CKD
8.3.2. Stage of CKD
8.3.3. Hgb value
8.3.4. Blood pressure
8.3.5. Dose of ESA and if the dose is an increase or decrease from previous appointment
8.3.6. Lot number and expiration date of medication
8.3.7. Desired follow-up appointment schedule

Copyright © 2017 University of Wisconsin Hospitals and Clinics Authority
Contact: Lee Vermeulen, CCKM@uwhealth.org Last Revised:
 
11/2017CCKM@uwhealth.org

References:
1. Kidney Disease: Improving Global Outcomes (KDIGO) Anemia Work Group. KDIGO Clinical
Practice Guideline for Anemia in Chronic Kidney Disease. Kidney inter., Suppl. 2012; 2: 279–335.
2. National Kidney Foundation. K/DOQI Clinical Practice Guidelines and Clinical Practice
Recommendations for Anemia of Chronic Kidney Disease in Adults. Am J Kidney Dis 2006;
47(suppl 3):S11-S145
3. Singh AK, Szczech L, Tant L, et al. Correction of Anemia with Epoetin Alfa in Chronic Kidney
Disease. N Engl J Med 2006; 335:2085-2098
4. Drueke TB, Locatelli F, Clyne N, et al. Normalization of Hemoglobin Level in Patients with Chronic
Kidney Disease and Anemia. N Engl J Med 2006; 355: 2071-2084
5. Pfeffer MA, Burdmann EA, Chen C, et al. A Trial of Darbepoetin Alfa in Type 2 Diabetes and
Chronic Kidney Disease. N Engl J Med 2009; 361:2019-2032
6. Chandler F, Harchowal J, Macdougall IC. Intravenous Iron Sucrose: Establishing a Safe Dose. Am J
Kidney Dis 2001; 38(5): 988-991
7. Blaustein DA, Schwenk MH, Chattopadhyay J, et al. The Safety and Efficacy of an accelerated iron
sucrose dosing regimen in patients with chronic kidney disease. Kidney Int 2003; 64(suppl 87):
S72-77
8. Blaustein DA, Schwenk MH, Chattopadhyay J, et al. Recent experience with high-dose
intravenous iron administration. Kidney Int 2006; 70:S26-29
9. Vikrant S. Optimum dosage regimen for iron sucrose. Kidney Int. 2007; 72:225

Order Mode:
Medications: Protocol/Policy, Without Cosign
Laboratory Orders: Cosign Required, Protocol/Policy

Collateral Documents/Tools:
UW Health Hypertension – Adult - Clinical Practice Guideline
Kidney – Anemia Clinic Smart Set [3258]

Approved By:
UW Health Ambulatory Protocol Committee: November 2013, *October 2015
UW Health Lab Practices Committee: November 2013, *October 2015
UWHC Pharmacy and Therapeutics Committee: November 2013, *November 2015
UWHC Medical Board: December 2013, *November 2015
UW Health Chief Medical Officer: January 2013, *November 2015

Effective Date: November 2015

Scheduled for Review: November 2017
* Expedited Review

Copyright © 2017 University of Wisconsin Hospitals and Clinics Authority
Contact: Lee Vermeulen, CCKM@uwhealth.org Last Revised:
 
11/2017CCKM@uwhealth.org