Predictors of long-term renal outcome in XXXX trials: lessons learned from the @entity7634 - @entity1988 cohort.

@entity8818 @entity644 @entity1 @entity1988 @entity1011 @entity7634
OBJECTIVE: There is a need to determine which response measures in @entity1988 trials are most predictive of good long-term renal function. We used data from the @entity7634 - @entity1988 Trial to evaluate the performance of @entity644 , serum @entity1011 ( @entity8818 ), and urinary red blood cells (RBCs) as predictors of good long-term renal outcome. METHODS: @entity1 from the @entity7634 - @entity1988 Trial with @entity644 , serum @entity8818 , and urinary RBC measurements at 3, 6, or 12 months and with a minimum of 7 years of followup were included (n   =   76). We assessed the ability of these clinical biomarkers at 3, 6, and 12 months after randomization to predict good long-term renal outcome (defined as a serum @entity8818 value  <=1.0 mg/dl) at 7 years. Receiver operating characteristic curves were generated to assess parameter performance at these time points and to select the best cutoff for individual parameters. Sensitivity and specificity were calculated for the parameters alone and in combination. RESULTS: A @entity644 value of <0.8 gm/day at 12 months after randomization was the single best predictor of good long-term renal function (sensitivity 81% and specificity 78%). The addition of serum @entity8818 to @entity644 as a composite predictor did not improve the performance of the outcome measure; addition of urinary RBCs as a predictor significantly decreased the sensitivity to 47%. CONCLUSION: This study demonstrates that the level of @entity644 at 12 months is the individual best predictor of long-term renal outcome in @entity1 with @entity1988 . Inclusion of urinary RBCs as part of a composite outcome measure actually undermined the predictive value of the trial data. We therefore suggest that urinary RBCs should not be included as a component of clinical trial response criteria in @entity1988 .
