End-stage renal disease and initiation of hemodialysis (HD) adversely affect health-related quality of life (HRQOL). There are currently no data evaluating the effect of pharmaceutical care (PC) on HRQOL in HD patients. HD patients were randomized to receive PC; one-on-one, in-depth medication reviews conducted by a clinical pharmacist or Standard of Care (SOC); and brief medication reviews conducted by dialysis nurses. The renal quality of life profile (RQLP) was administered at baseline and then at 1 and 2 years after study initiation. The RQLP is a 43-item questionnaire that has 5 dimensions: Eating/Drinking, Physical Activities, Leisure Time, Psychosocial Activities, and Impact of Treatment, where increasing scores reflect worsening of HRQOL. A total of 107 patients were enrolled (SOC: n=46; PC: n=61). Besides gender, there were no differences in the demographics or the baseline total RQLP scores. The mean+/-SD total RQLP scores at Year 1 were significantly worse in SOC compared with PC (88+/-31 vs. 71+/-34, respectively; P=0.03). Significant worsening of Eating and Drinking (5.9+/-3.3 vs. 4.4+/-3.1, respectively; P=0.04), Physical Activities (37+/-13.6 vs. 30+/-16.3, respectively; P=0.04), and Leisure Time scores (8.3+/-3.4 vs. 5.9+/-3.6, respectively; P=0.03) was also observed in the SOC group. After 2 years, only the SOC patients had worsening of Leisure Time (7.5+/-3.0 vs. 5.2+/-3.9, respectively; P=0.04). No other parameters were different between the groups after 2 years. These data indicate that patients who have clinical care provided by pharmacists do not have worsened HRQOL after 1 year and are able to maintain HRQOL for an additional year.