OBJECTIVES: This study assessed the measurement properties of the Functional Assessment of Cancer Therapy – Anaemia (FACT-An) for use in patients with anaemia associated with chronic kidney disease (CKD). METHODS: FACT-An data were collected in an open label dose titration, randomised phase 2b clinical trial (study FGCL-4592-041) with non-dialysis CKD patients with anaemic stages 3 and 4.  FACT-An was completed at baseline, and treatment Weeks 9 and 17. RESULTS: Data from 145 patients were analyzed. Average age was 64.4 yrs (SD=11.3), 63% were female.  Average hemoglobin (Hb) level was 9.7 g/dL (SD=0.7), 11.4 (SD=1.2), and 11.7 (SD=1.1) at baseline, Weeks 9 and 17, respectively. Internal consistency and test-retest reliability were >0.70 for all subscales, except the Emotional Well-being subscale (EWB). Convergent validity was shown by correlations between FACT-An Total score, Anaemia subscale, and Fatigue subscale with SF-36v2 Physical Functioning (0.57-0.61) and Vitality (0.73-0.76). Correlations were low between FACT-An Total score, Anaemia subscale, and Fatigue subscale and Hb level at baseline (0.14-0.15), but increased at treatment Weeks 9 (0.16-0.20) and 17 (0.23-0.26). A responder analysis showed that FACT-An Anaemia and Fatigue subscales were responsive in detecting  small but significant  changes in Hb level at week 9.  The FACT-An Total score,  Anaemia subscale, and Fatigue subscale, were able to detect SF-36v2 Vitality score increase of 5 points from baseline to Week 17.  Based on distributional and anchor-based methods, the minimally important difference was estimated as score change of 8-10 for FACT-An Total score, 4-7 for Anaemia subscale, and 3-5 for Fatigue subscale. CONCLUSIONS: This study shows the FACT-An Total score, Anaemia subscale, and Fatigue subscale to be a reliable, valid, and responsive instrument for CKD patients with anaemia.   Results on the ability to detect Hb changes were limited due to the narrow range of Hb values available in this study.