BASE-LINE CHARACTERISTICS IN THE MODIFICATION OF DIET IN RENAL-DISEASE STUDY (VOL 3, PG 1819, 1993)

The Modification of Diet in Renal Disease Study is randomized, multice nter, clinical trial designed to determine the effects of three levels of dietary control of protein and phosphorus and two levels of blood pressure control on the rate of decline of kidney function among perso ns with chronic renal disease. Study participants were assigned to one of two studies, Study A or Study B, depending on their GFR just befor e randomization. Within each study, participants were randomly allocat ed to one of two levels of blood pressure control and to one of two di etary interventions according to separate 2 x 2 factorial designs. A t otal of 840 men and women aged 18 to 70 were randomized. This report s ummarizes the demographic, biochemical, and clinical characteristics o f the randomized participants at the time of entry into the trial, ove rviews the protocol and purposes of the baseline period before randomi zation, and evaluates the balance among the treatment intervention gro ups within Studies A and B at the time of randomization. Major indicat ors of renal function were found to be well balanced among the treatme nt groups. Selected baseline characteristics of participants in the Mo dification of Diet in Renal Disease Study are compared with those of o ther renal clinical trials and with those of new cases of treated ESRD reported in the United States Renal Data System.