Original Primary Outcome: Mean total kidney volume assessed by magnetic resonance imaging at 3 timepoints from the first day to the last day on study medication

Current Secondary Outcome:

• Course of Calculated GFR (mL/Min/1.73 m^2) From Month 24 to Month 60 [ Time Frame: Months 24, 36, 48 and 60 ]
  Course of calculated GFR (mL/min/1.73 m^2) at Months 24, 36, 48 and 60
• Calculated GFR, Change From Baseline at Month 60 by Baseline cGFR [ Time Frame: Months 24, 36, 48 and 60 ]
  Change in renal function was assessed by the estimated Glomerular Filtration Rate (eGFR) using the abbreviated (4 variables) Modification of Diet in Renal Disease (MDRD-4) formula which was developed by the MDRD Study Group and has been validated in patients with chronic kidney disease. The MDRD-4 formula used for the eGFR calculation is: eGFR (mL/min/1.73m^2) = 186.3*(C^-1.154)*(A^-0.203)*G*R, where C is the serum concentration of creatinine (mg/dL), A is age (years), G=0.742 when gender is female, otherwise G=1, R=1.21 when race is black, otherwise R=1. The changes in renal function were analyzed via analysis of covariance (ANCOVA) with treatment, pre-transplant hepatitis C virus status and randomization eGFR as covariates. Based on these ANCOVA analyses, the least-squares mean and standard errors of change were reported.
• Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [ Time Frame: Baseline, Months 12 and 24 ]
  Changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP), at baseline and then months 12 and 24
• Calculated GFR (mL/Min/1.73 m^2), Change From Baseline by Visit [ Time Frame: Months 3, 6, 9, 12, 18 and 24 ]
  Change in renal function was assessed by the Glomerular Filtration Rate (GFR) using the abbreviated (4 variables) Modification of Diet in Renal Disease (MDRD-4) formula which was developed by the MDRD Study Group and has been validated in patients with chronic kidney disease. The MDRD-4 formula used for the eGFR calculation is: eGFR (mL/min/1.73m^2) = 186.3*(C^-1.154)*(A^-0.203)*G*R, where C is the serum concentration of creatinine (mg/dL), A is age (years), G=0.742 when gender is female, otherwise G=1, R=1.21 when race is black, otherwise R=1. The changes in renal function were analyzed via analysis of covariance (ANCOVA) with treatment, pre-transplant hepatitis C virus status and randomization eGFR as covariates. Based on these ANCOVA analyses, the least-squares mean and standard errors of change were reported.

Original Secondary Outcome:

• changes in mean cyst and parenchyma volumes assessed by magnetic resonance imaging between the first and last day on study medication.
• changes in renal function assessed by urinalysis at 8 timepoints from the first day to last day on study medication.
• Incidence of newly developing end-stage renal disease (ESRD) assessed by number of patients who require renal replacement therapy during the conduct of the trial
• safety and tolerability of the study drug assessed by monitoring and recording of aderse events, serious adverse events, and all infections
• Changes in blood pressure between the first and last day on study medication assessed by blood pressure measurements at 10 timepoints

Dates:
Date Received: December 20, 2006
Date Started: December 2006
Date Completion:
Last Updated: January 13, 2015
Last Verified: January 2015