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To examine the impact of different Hgb target strategies on outcomes of CKD patients based on responsiveness to ESA

Researchers
#1
  • Currently, the FDA approved ESA label recommends a 10-11 g/dL target Hgb. This decision was driven by safety signals reported by clinical trials.
  • TREAT indicated that responsiveness to ESA plays an important role in treating anemic CKD patients
  • There is no empirical evidence on appropriate Hgb targets among responders vs. nonresponders.
  • We hypothesis that individualized ESA treatment strategies are needed. Specifically, targeting Hgb higher than 11 g/dL might be beneficial to patients with optimal responsiveness to ESA.
  • Stratified by responsiveness to ESA as defined in CHOIR study, we will emulate CHOIR trial based on CHOIR data and by appropriately controlling for time-dependent confounding between ESA therapy and achieved Hgb level.
#2

@mthamer:

Interesting proposal. Can you elucidate what the CHOIR criteria were, and what you want to emulate?

#3

Here is a link to the paper. http://www.nejm.org/doi/full/10.1056/NEJMoa065485

The key inclusion criteria are below (extracted from the study methods):
We conducted an open-label, randomized trial to study the risks and benefits of the correction of anemia in patients with chronic kidney disease who were not receiving dialysis. We enrolled 1432 patients at 130 sites in the United States. At enrollment, patients had to be at least 18 years of age, have a hemoglobin level of less than 11.0 g per deciliter, and have chronic kidney disease, defined by an estimated glomerular filtration rate (GFR) of 15 to 50 ml per minute per 1.73 m2 of body-surface area, with the use of the Modification of Diet in Renal Disease (MDRD) formula. Key exclusion criteria included the presence of uncontrolled hypertension, active gastrointestinal bleeding, an iron-overload state, a history of frequent transfusions in the previous 6 months, refractory iron-deficiency anemia, active cancer, previous therapy with epoetin alfa, or angina pectoris that was unstable or present at rest.

#4

Thank you Mark for your prompt response to Christian’s question about
CHOIR. We just joined OHDSI and are impressed with how quickly information
is transmitted. We are eager to engage with others interested in similar
research ideas.

Best,
Mae

t