NKF-KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Anemia in Chronic Kidney Disease

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NKF-KDOQI Clinical Practice Guidelines and
Clinical Practice Recommendations for Anemia in
Chronic Kidney Disease
UPDATE OF HEMOGLOBIN TARGET Am.J.Kidney.Dis. 50
(3)471-530, 2007.
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KDOQI AnemiaOrganization

• Evidence Review Team
• Tufts New England Medical Center
• Work Group
• 9 Adult Nephrologists
• 2 Pediatric Nephrologists
• 2 Hematologists
• 1 Nurse Practitioner
• 1 Dietician

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CPR and CPG 2.1 Hb TargetIntroduction

• The Hb target is the intended aim of ESA therapy
  for the individual CKD patient. In clinical
  practice, achieved Hb results vary considerably
  from the Hb target.

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CPR 2.1.1Considerations

• In the opinion of the work group, selection of
  the Hb target and selection of the Hb level at
  which ESA therapy is initiated in the individual
  patient should include consideration of potential
  benefits (including improvement in quality of
  life and avoidance of transfusion) and potential
  harms (including the risk of life-threatening
  adverse events). (Clinical Practice
  RECOMMENDATION)

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CPR 2.1.2Selection of the Hb target

• In the opinion of the work group, in dialysis and
  non-dialysis CKD patients receiving ESA therapy,
  the selected Hb target should generally be in the
  range of 11.0 to 12.0 g/dL. (Clinical Practice
  RECOMMENDATION)

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CPG 2.1.3Hb targets to avoid

• In dialysis and non-dialysis CKD patients
  receiving ESA therapy, the Hb target should not
  be above 13.0 g/dL. (Clinical Practice GUIDELINE
  - MODERATELY STRONG EVIDENCE)

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Rationale 2.1.2
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Distinguishing Target Hb from Achieved Hb
Rationale 2.1.2

• Target Hb is the aim of ESA therapy
• Achieved Hb is the result of ESA therapy
• Achieved Hb results vary considerably from the Hb
  target
• Safety of achieved Hb relative to 11-12 g/dL
  target Hb or Hb gt 11 g/dL threshold is
  well-established

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The Hb target should not be above 13.0 g/dL
(Moderately Strong Recommendation)
Rationale 2.1.3

• Evidence from RCTs
• Considered all trials that compared Hb target gt
  13.0 g/dL to lower target
• All these RCTs tested the hypothesis that the
  higher target would prevent adverse
  cardiovascular events or mortality, or all cause
  mortality
• None showed a benefit on those outcomes

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Meta-Analysis

• Performed by Evidence Review Team
• RCTs with 6 months follow-up, no restriction on
  study size
• Statistical model random effects
• Separated dialysis from non-dialysis CKD trials
• Combined all cardiovascular disease events for
  analysis of cardiovascular adverse event risk

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Relative mortality risk for assignment to higher
treatment targets Non-Dialysis-CKD
Rationale 2.1.3
Higher Hb Target
Relative Risk 1.02, 95 CI 0.63-1.61
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Relative risk of cardiovascular events for
assignment to higher targets Non-dialysis CKD
Rationale 2.1.3
Relative Risk 1.24, 95 CI 1.02-1.51
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Relative mortality risk for assignment to higher
treatment targets Dialysis CKD
Rationale 2.1.3
Higher Hb Target
14.0
13.0-14.0
13.5-16.0
13.5-14.5
Relative Risk 1.12, 95 CI 0.91-1.37
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Relative risk of cardiovascular events for
assignment to higher targets Dialysis CKD
Rationale 2.1.3
Higher Hb Target
14.0
13.0-14.0
13.5-14.5
Relative Risk 1.14, 95 CI 0.79-1.64
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The Statement Hb Target should not be above 13
g/dL
Rationale 2.1.3

• Reflects Work Group judgment
• The possibility to cause harm weighs more heavily
  than the potential to improve quality of life and
  reduce the likelihood of transfusions
• Moderately strong, evidence-based, clinical
  practice guideline