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Anemia Management in Chronic Kidney Disease – Adult – Inpatient/Ambulatory

Anemia Management in Chronic Kidney Disease – Adult – Inpatient/Ambulatory - Clinical Hub, UW Health Clinical Tool Search, UW Health Clinical Tool Search, Clinical Practice Guidelines, Urology and Nephrology


1
Anemia Management in Chronic Kidney
Disease – Adult– Inpatient/Ambulatory
Clinical Practice Guideline
Table of Contents
EXECUTIVE SUMMARY ........................................................................................................... 2
SCOPE ...................................................................................................................................... 6
METHODOLOGY ...................................................................................................................... 7
DEFINITIONS (OPTIONAL): ..................................................................................................... 8
INTRODUCTION ....................................................................................................................... 9
RECOMMENDATIONS .............................................................................................................. 9
BENEFITS/HARMS OF IMPLEMENTATION ...........................................................................12
REFERENCES .........................................................................................................................12
APPENDIX A ............................................................................................................................12
CPG Contact for Changes: CPG Contact for Content:
Name: Philip Trapskin, PharmD Name: Sara Shull, PharmD, MBA
Phone Number: 263-1328 Phone Number: 262-1817
Email Address: ptrapskin@uwhealth.org Email Address: ssmith-shull@uwhealth.org
Note: Active Table of Contents
Click to follow link
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2
Guideline Author(s):
Kimberly Holdener, PharmD
Coordinating Team Members:
Katie Cunningham, PharmD, BCPS
Jillian Descourouez, PharmD
David Hager, PharmD, BCPS
Review Individuals/Bodies:
Micah Chan, MD
R. Allan Jhagroo, MD
Arjang Djamali, MD
Committee Approvals/Dates:
Pharmacy and Therapeutics: January 2011, November 2014
Release Date: December 2014
Next Review Date: November 2017
Copyright © 2014 Univ ersity of Wisconsin Hospitals and Clinics Authority
Contact: Lee Vermeulen, CCKM@uwhealth.org Last Revised: 12/2014CCKM@uwhealth.org

3
Executive Summary
Guideline Overview
This document is intended to guide clinicians in the management of anemia due to chronic
kidney disease (CKD) in the ambulatory and inpatient setting.
Key Practice Recommendations
1. Diagnosis of anemia in adults with CKD occurs when the hemoglobin (Hgb)
concentration is5: (Class IIb, Level of Evidence C)
a. Less than 13 g/dL in adult males
b. Less than 12 g/dL in adult females
2. Anemia evaluation in patients with CKD and anemia should include the following5: (Class
IIb, Level of Evidence C)
a. Complete blood count, including hemoglobin concentration, red blood cell
indices, white blood cell count, and differential and platelet count
b. Absolute reticulocyte count
c. Serum ferritin
d. Iron/total iron binding capacity (TIBC) with serum transferring saturation (TSAT)
e. Vitamin B12 and folate
f. Fecal occult blood test
3. Iron Supplementation
a. Indications for iron therapy in CKD patients with anemia6: (Class II, Level of
Evidence C)
i. Transferrin saturation is ≤20% and serum ferritin is ≤100 ng/mL in non-
dialysis (ND) or peritoneal dialysis (PD)
ii. Transferrin saturation is ≤20% and serum ferritin is ≤200 ng/mL in
hemodialysis (HD) patients
b. Iron supplementation should not be given if the transferrin saturation is > 50% or
the ferritin is > 800 ng/mL.8,9,16
c. For CKD ND patients, select the route of iron based on the severity of iron
deficiency, availability of venous access, prior response to iron therapy, prior side
effects, patient compliance, and cost.5 (Class IIb, Level of Evidence C)
d. 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.5,6 (Class IIb, Level of Evidence C)
e. Iron Dosing: (Class IIa, Level of Evidence C)
i. Oral supplementation
a) Patients with iron deficiency should receive iron supplementation
of 65 to 195 mg elemental iron daily (ferrous sulfate 325 mg one
to three times daily)
b) Patients who receive ESAs should receive ferrous sulfate 325
mg by mouth one to two times daily to maintain iron levels within
goal range.
ii. Intravenous supplementation10,11,12,13
a) IV iron may be given on consecutive days if desired
b) Iron sucrose is the preferred agent due to ease of dosing.
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4
c) Two doses of iron sucrose 500 mg in 250 mL of 0.9% sodium
chloride infused intravenously over 3 hours should be given for
iron deficiency.
d) Iron sucrose may alternatively be given as three doses of 300
mg in 250 mL of 0.9% sodium chloride infused over 90 minutes
based on patient convenience
e) The maximum daily dose of iron sucrose is 500 mg.
f) Ferric gluconate may be given as 4 doses of 250mg IV each
infused over 1 hour for iron deficiency
4. Erythropoiesis stimulating agents (ESAs)
a. If no other source of anemia is discovered, initiation of treatment with ESAs is
indicated if the following criteria are met5,14: (Class II, Level of Evidence A)
i. Hgb is less than 9.5 g/dL (or hematocrit [Hct] less than 28% when the
Hgb is not available) in non-dialysis patients with CKD Stage 3, 4 or 5.
(Class II, Level of Evidence A)
a) Decision for initiation should be individualized based on the rate of
fall in Hgb concentration, prior response to iron therapy,
transfusion risk, ESA risk and current anemia symptoms (Class II,
Level of Evidence A)
ii. Hgb less than 10 g/dL in dialysis patients (Class II, Level of Evidence A)
b. The use of ESAs to intentionally increase the Hgb level greater than 12 g/dL may
be associated with increased risk for cardiovascular events.15,16,17 (Class I, Level
of Evidence A)
c. ESAs should not be administered to any patient with a Hgb >11 g/dL (or Hct
≥33% when the Hgb is not available).14,18 (Class II, Level of Evidence C)
d. ESA therapy should be used with great caution, if at all, in CKD patients with
active malignancy, a history of stroke, or a history of malignancy.5 (Class I, Level
of Evidence A)
e. ESAs should not be administered to patients who have a systolic blood pressure
≥180 mmHg.19 (Class II, Level of Evidence C)
f. ESAs should not be administered to treat active bleeding (Class II, Level of
Evidence C)
g. A medication guide must be provided to patients in accordance with the Food
and Drug Administration risk evaluation and mitigation strategy (REMS) program.
i. Providers must review the content of the medication guide with the
patient and counsel each patient on the risks and benefits prior to initial
administration of ESAs.
h. ESA Dosing:
i. Darbepoetin is the ESA of choice at UWHC.
ii. Initial doses of darbepoetin (for darbepoetin/epoetin alfa therapy naïve
patients):
a) Patients not on dialysis:
a) Darbepoetin 100 mcg subcutaneously every 4 weeks or
60mcg every 2 weeks.
b) Dialysis patients:
a) Initial darbepoetin dose should be calculated from Table 2
b) Round dose up or down to the nearest syringe size
available (25 mcg, 40 mcg, 60 mcg, 100 mcg, 150 mcg
and 200 mcg).
Copyright © 2014 Univ ersity of Wisconsin Hospitals and Clinics Authority
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5
c) Dose frequency may be extended to prevent drug waste
for calculated doses of less than 12.5 mg per week
Table 2. Initial weekly intravenous darbepoetin
dose for dialysis patients
c) Transplant recipients may require higher doses due to
medications that contribute to anemia
iii. Patients on ESAs should be continued on their outpatient dose when
admitted to the hospital.6
iv. Use the lowest dose of ESA that will gradually increase the Hgb
concentration to the lowest level sufficient to avoid the need for red
blood cell transfusion.14 (Class II, Level of Evidence C)
iii. Dose Escalation (Class II, Level of Evidence C)
a) If Hgb is less than 9.5 g/dL and the increase in Hgb is less than 1
g/dL (or increase in Hct is less than 3% over the past 4 weeks
when the Hgb is not available), increase dose to next available
syringe size
b) Do not increase the dose more than once a month
iv. Dose Reduction (Class II, Level of Evidence C)
c) If Hgb is greater than 11 g/dL the ESA should be held
a) Once Hgb is less than 11 g/dL the ESA may be restarted
b) When resuming medication, increase dosing interval by 1-
2 weeks OR decrease dose to next available syringe size
d) If the increase in Hgb is greater than 1.5 g/dL (or increase in Hct is
greater than 4.5% in a 4 week period when the Hgb is not
available), increase dosing interval by 1-2 weeks OR decrease
dose to next available syringe size
v. Epoetin alfa may be converted to darbepoetin (Table 3).
Table 3. Dose Conversion from epoetin alfa to darbepoetin17
Previous Epoetin Weekly Dose
(units/week)
Weekly Darbepoetin Dose
(mcg/week)
<2500 6.25
2500 to 4999 12.5
5000 to 10,999 25
11,000 to 17,999 40
18,000 to 33,999 60
34,000 to 89,000 100
>90,000 200
Hemoglobin (g/dL) Starting dose (mcg/kg total body
weight) IV weekly
8 – 9.9 0.45
<8 0.75
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6
Companion Documents
Delegation Protocol: Anemia Management in Pre-dialysis Chronic Kidney Disease Patients
Delegation Protocol: Anemia Management in Abdominal Transplant Recipients
Patient Resources:
HFFY: Anemia of Chronic Kidney Disease
Scope
Disease/Condition(s):
Patients with chronic kidney disease who require anemia management
Clinical Specialty:
Nephrology
Intended Users:
Physicians, Physician Assistants, Nurse Practitioners, Pharmacists
CPG objective(s):
To standardize and provide recommendations for iron and ESA management (dosing,
monitoring, patient assessment) for adult patients across UW Health
Target Population:
Adult ambulatory patients whose iron or ESA therapy is managed by a UW Health primary care
or specialty clinic
Interventions and Practices Considered:
This guideline recommends anemia management for adult patients with chronic kidney disease
in order to help standardize care in the ambulatory setting.
Copyright © 2014 Univ ersity of Wisconsin Hospitals and Clinics Authority
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7
Methodology
Methods Used to Collect/Select the Evidence:
1. Searches of electronic databases (e.g., national and international guidelines for
immunosuppression management)
2. Hand-searches of Published Literature (Primary Sources)
3. Hand-searches of Published Literature (Secondary Sources)
Methods Used to Assess the Quality and Strength of the Evidence:
Weighing according to rating scheme (scheme given below).
Rating Scheme for the Strength of the Evidence:
A modified Grading of Recommendations Assessment, Development and Evaluation (GRADE)
developed by the American Heart Association and American College of Cardiology (Figure 1)
have been used to assess the Quality and Strength of the Evidence in this Clinical Practice
Guideline.1
Figure 1: Quality of Evidence and Strength of Recommendation Grading Matrix*
Copyright © 2014 Univ ersity of Wisconsin Hospitals and Clinics Authority
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8
Methods Used to Analyze the Evidence:
1. Systemic Reviews
2. Expert Opinion
Methods Used to Formulate the Recommendations:
A review of current literature and clinical practice guidelines, survey of provider preferences,
and trends from current practice were all incorporated into the formulation of recommendations.
Definitions:
1. Creatinine Clearance (CrCl): measure of the rate in which creatinine, a byproduct of
protein metabolism, is cleared from the blood by the kidneys2
2. Glomerular Filtration Rate (GFR): quantity of glomerular filtrate formed each minute in
the nephrons located in the kidneys3
3. Chronic Kidney Disease (CKD): glomerular filtration rate [GFR] <60 mL/min/1.73 m2 or
kidney damage for ≥ 3 months4
Table 1. Stages of Chronic Kidney Disease
Stage Description GFR
(ml/min/1.73m2)
1
Kidney damage with
normal or ν GFR > 90
2
Kidney damage with
mild pi GFR 60 – 80
3 Moderate pi GFR 30 – 59
4 Severe pi GFR 15-29
5 Kidney Failure < 15 (or dialysis)
4. Estimated Glomerular Filtration Rate (eGFR): an estimation of the GFR using the
Modification of Diet in Renal Disease (MDRD) equation to aid in the determination of
stage of CKD. The eGFR is reported by the laboratory for all outpatient serum creatinine
values.
5. Erythropoiesis-stimulating agent (ESA): Medications used to stimulate the production of
red blood cells such as epoetin alfa and darbepoetin alfa
Copyright © 2014 Univ ersity of Wisconsin Hospitals and Clinics Authority
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9
Introduction
Anemia is common in patients with CKD, and all patients with CKD should have their
hemoglobin (Hgb) measured at least annually or more often as clinically appropriate.5,6 The
risks and benefits of treatment with erythropoiesis-stimulating agents (ESAs) should be
carefully weighed before treatment initiation.
Post transplantation anemia (PTA) is a form of CKD-associated anemia. The management
of anemia in transplant recipients should parallel treatment considerations that are applied
to the general CKD patient population.7
Recommendations
1. Diagnosis of anemia in adults with CKD occurs when the Hgb concentration is5:
(Class IIb, Level of Evidence C)
a. Less than 13 g/dL in adult males
b. Less than 12 g/dL in adult females
2. Anemia evaluation in patients with CKD and anemia should include the following5:
(Class IIb, Level of Evidence C)
a. Complete blood count, including hemoglobin concentration, red blood cell
indices, white blood cell count, and differential and platelet count
b. Absolute reticulocyte count
c. Serum ferritin
d. Iron/TIBC with serum transferring saturation (TSAT)
e. Vitamin B12 and folate
f. Fecal occult blood test
3. Iron Supplementation
a. Indications for iron therapy in CKD patients with anemia6: (Class II, Level of
Evidence C)
i. Transferrin saturation is ≤20% and serum ferritin is ≤100 ng/mL in non-
dialysis (ND) or peritoneal dialysis (PD)
ii. Transferrin saturation is ≤20% and serum ferritin is ≤200 ng/mL in
hemodialysis (HD) patients
b. Iron supplementation should not be given if the transferrin saturation is > 50%
or the ferritin is > 800 ng/mL.8,9,16
c. For CKD ND patients, select the route of iron based on the severity of iron
deficiency, availability of venous access, prior response to iron therapy, prior
side effects, patient compliance, and cost.5 (Class IIb, Level of Evidence C)
d. 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.5,6 (Class IIb, Level of Evidence C)
e. Iron Dosing: (Class IIa, Level of Evidence C)
i. Oral supplementation
Copyright © 2014 Univ ersity of Wisconsin Hospitals and Clinics Authority
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10
a) Patients with iron deficiency should receive iron supplementation
of 65 to 195 mg elemental iron daily (ferrous sulfate 325 mg one
to three times daily)
b) Patients who receive ESAs should receive ferrous sulfate 325
mg by mouth one to two times daily to maintain iron levels within
goal range.
ii. Intravenous supplementation10,11,12,13
a) IV iron may be given on consecutive days if desired
b) Iron sucrose is the preferred agent due to ease of dosing.
c) Two doses of iron sucrose 500 mg in 250 mL of 0.9% sodium
chloride infused intravenously over 3 hours should be given for
iron deficiency.
d) Iron sucrose may alternatively be given as three doses of 300 mg
in 250 mL of 0.9% sodium chloride infused over 90 minutes based
on patient convenience
e) The maximum daily dose of iron sucrose is 500 mg.
f) Ferric gluconate may be given as 4 doses of 250mg IV each
infused over 1 hour for iron deficiency
4. Erythropoiesis stimulating agents
a. If no other source of anemia is discovered, initiation of treatment with ESAs is
indicated if the following criteria are met5,14: (Class II, Level of Evidence A)
i. Hgb is less than 9.5 g/dL (or Hct less than 28% when the Hgb is not
available) in non-dialysis patients with CKD Stage 3, 4 or 5. (Class II,
Level of Evidence A)
a) Decision for initiation should be individualized based on the rate of
fall in Hgb concentration, prior response to iron therapy,
transfusion risk, ESA risk and current anemia symptoms (Class II,
Level of Evidence A)
ii. Hgb less than 10 g/dL in dialysis patients (Class II, Level of Evidence A
b. The use of ESAs to intentionally increase the Hgb level greater than 12 g/dL
may be associated with increased risk for cardiovascular events.15,16,17
(Class I, Level of Evidence A)
c. ESAs should not be administered to any patient with a Hgb >11 g/dL (or Hct
≥33% when the Hgb is not available).14,18 (Class II, Level of Evidence C)
d. ESA therapy should be used with great caution, if at all, in CKD patients with
active malignancy, a history of stroke, or a history of malignancy.5 (Class I,
Level of Evidence A)
e. ESAs should not be administered to patients who have a systolic blood
pressure ≥180 mmHg.19 (Class II, Level of Evidence C)
f. ESAs should not be administered to treat active bleeding (Class II, Level of
Evidence C)
g. A medication guide must be provided to patients in accordance with the Food
and Drug Administration risk evaluation and mitigation strategy (REMS)
program.
i. Providers must review the content of the medication guide with the
patient and counsel each patient on the risks and benefits prior to initial
administration of ESAs.
h. Dosing:
i. Darbepoetin is the ESA of choice at UWHC.
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11
ii. Initial doses of darbepoetin (for darbepoetin/epoetin alfa therapy naïve
patients):
1) Patients not on dialysis:
a) Darbepoetin 100 mcg subcutaneously every 4 weeks or
60mcg every 2 weeks.
b) Transplant recipients may require higher doses due to
medications that contribute to anemia
2) Dialysis patients:
a) Initial darbepoetin dose should be calculated from Table 2
b) Round dose up or down to the nearest syringe size available
(25 mcg, 40 mcg, 60 mcg, 100 mcg, 150 mcg and 200 mcg).
c) Dose frequency may be extended to prevent drug waste for
calculated doses of less than 12.5 mg per week
Table 2. Initial weekly intravenous darbepoetin
dose for dialysis patients
iii. Inpatients on ESAs prior to admission should continue their outpatient
dose of darbepoetin.6
iv. Use the lowest dose of ESA that will gradually increase the Hgb
concentration to the lowest level sufficient to avoid the need for red
blood cell transfusion.14 (Class II, Level of Evidence C)
v. Dose Escalation (Class II, Level of Evidence C)
e) If Hgb is less than 9.5 g/dL and the increase in Hgb is less than 1
g/dL (or increase in Hct is less than 3% over the past 4 weeks
when the Hgb is not available), increase dose to next available
syringe size
f) Do not increase the dose more than once a month
vi. Dose Reduction (Class II, Level of Evidence C)
g) If Hgb is greater than 11 g/dL the ESA should be held
a) Once Hgb is less than 11 g/dL the ESA may be restarted
b) When resuming medication, increase dosing interval by 1-
2 weeks OR decrease dose to next available syringe size
h) If the increase in Hgb is greater than 1.5 g/dL (or increase in Hct is
greater than 4.5% in a 4 week period when the Hgb is not
available), increase dosing interval by 1-2 weeks OR decrease
dose to next available syringe size
vii. Epoetin alfa may be converted to darbepoetin (Table 3).
Table 3. Dose Conversion from epoetin alfa to darbepoetin17
Previous Epoetin Weekly Dose
(units/week)
Weekly Darbepoetin Dose
(mcg/week)
<2500 6.25
2500 to 4999 12.5
Hemoglobin (g/dL) Starting dose (mcg/kg total body
weight) IV weekly
8 – 9.9 0.45
<8 0.75
Copyright © 2014 Univ ersity of Wisconsin Hospitals and Clinics Authority
Contact: Lee Vermeulen, CCKM@uwhealth.org Last Revised: 12/2014CCKM@uwhealth.org

12
5000 to 10,999 25
11,000 to 17,999 40
18,000 to 33,999 60
34,000 to 89,000 100
>90,000 200
UW Health Implementation
Potential Benefits/Harms:
This guideline has been developed based on best evidence based recommendations. By
implementing the parameters set forth in the guideline, anemia patients with CKD will receive
iron therapy and ESAs appropriately and safely.
Potential Harms:
Side effects and adverse events associated with medications referenced.
Disclaimer
CPGs are described to assist clinicians by providing a framework for the evaluation and
treatment of patients. This Clinical Practice Guideline outlines the preferred approach for most
patients. It is not intended to replace a clinician’s judgment or to establish a protocol for all
patients. It is understood that some patients will not fit the clinical condition contemplated by a
guideline and that a guideline will rarely establish the only appropriate approach to a problem.
References
1. Tricoci P, Allen J, Kramer J, Califf R, et al. Scientific evidence underlying the
ACC/AHA Clinical Practice Guidelines. JAMA. 2009; 301(8):831-841.
2. MedicineNet. http://www.medterms.com. Updated June 14, 2012. Accessed
February 6, 2014.
3. The Free Dictionary. http://medical-dictionary.thefreedictionary.com. Accessed
February 6, 2014.
4. National Kidney Foundation. K/DOQI Clinical Practice Guidelines for Chronic Kidney
Disease: Evaluation, Classification and Stratification. Am J Kidney Dis. 2002;
39(2)(Supple 1):S1-S266.
5. KDIGO Anemia Work Group. KDIGO Clinical Practice Guideline for Anemia in
Chronic Kidney Disease. Kidney Int Suppl. 2012;2(4):279-335.
6. National Kidney Foundation. KDOQI Clinical Practice Guidelines and Clinical
Practice Recommendations for Anemia in Chronic Kidney Disease. Am J Kidney Dis.
2006; 47(5)(suppl 3):S11-145.
7. National Kidney Foundation. IV. Clinical practice recommendations for anemia in
chronic kidney disease in transplant recipients. Am J Kidney Dis. 2006;47(5)(suppl
3):S109-116.
8. Kapoian T, O’Mara NB, Singh AK, et al. Ferric gluconate reduces epoetin
requirements in hemodialysis patients with elevated ferritin. J Am Soc Nephrol 19:
372-379, 2008.
Copyright © 2014 Univ ersity of Wisconsin Hospitals and Clinics Authority
Contact: Lee Vermeulen, CCKM@uwhealth.org Last Revised: 12/2014CCKM@uwhealth.org

13
9. Coyne DW, Kapoain T, Suki W. Ferric gluconate is highly efficacious in anemic
hemodialysis patients with high serum ferritin and low transferrin saturation: Results
of the dialysis patients’ response to IV iron with elevated ferritin (DRIVE) study. J
Am Soc Nephrol 18: 975-984, 2007.
10. Chandler F, Harchowal J, Macdougall IC. Intravenous Iron Sucrose: Establishing a
Safe Dose. Am J Kidney Dis 2001; 38(5): 988-991
11. 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
12. Vikrant S. Optimum dosage regimen for iron sucrose. Kidney Int. 2007; 72:225
13. Folkert VW, Beckie M, Agarway R, et al. Chronic Use of Sodium Ferric Gluconate
Complex in Hemodialysis Patients: Safety of Higher-Dose (>250 mg) Administration.
Am J Kidney Dis 2003; 41:651-657.
14. Food and Drug Administration Website.
http://www.fda.gov/Drugs/DrugSafety/ucm259639.htm. Accessed July 3, 2014.
15. Drueke TB, Locatelli F, Clyne N, et al: Normalization of hemoglobin level in patients
with chronic kidney disease and anemia. N Engl J Med 355:2071-2084, 2006
16. Singh AK, Szczech L, Tang KL, et al: Correction of anemia with epoetin alfa in
chronic kidney disease. N Engl J Med 355:2085-2098, 2006
17. 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
18. National Kidney Foundation. K/DOQI US Commentary on the 2012 KDIGO Clinical
Practice Guideline for Anemia in CKD. Am J Kidney Dis 2013; 62(5):849-859
19. Aranesp (darbepoetin). [package insert]. Thousand Oaks, CA: Amgen; December
2013.
Copyright © 2014 Univ ersity of Wisconsin Hospitals and Clinics Authority
Contact: Lee Vermeulen, CCKM@uwhealth.org Last Revised: 12/2014CCKM@uwhealth.org