Figure 7-B

In 1997, the National Kidney Foundation began the Dialysis Outcomes Quality Initiative, or DOQI, to improve care for dialysis patients around the world. As part of that initiative, the Kidney Disease Outcomes Quality Initiative or K/DOQI was undertaken to provide evidence-based clinical practice guidelines for all phases of kidney disease and related complications, from diagnosis to monitoring and management.

Treatment recommendations will be addressed in the K/DOQI Guidelines on Bone Metabolism and Disease in CKD, which are expected to be released in 2003. A preliminary draft was presented at the American Society of Nephrology meeting held in Philadelphia in 2002. A K/DOQI target range of 150 to 300 pg/mL for PTH was proposed.

These recommendations reflect the growing concern of experts in this field that there is a need to impose tighter controls on the concentrations of PTH, Ca, P, and Ca´P that should be permitted in ESRD patients. The K/DOQI recommendation on target range for PTH levels is expected to be between 150 and 300 pg/mL.

In 1997, the National Kidney Foundation began the Dialysis Outcomes Quality Initiative, or DOQI, to improve care for dialysis patients around the world. As part of that initiative, the Kidney Disease Outcomes Quality Initiative or K/DOQI was undertaken to provide evidence-based clinical practice guidelines for all phases of kidney disease and related complications, from diagnosis to monitoring and management.

Treatment recommendations will be addressed in the K/DOQI Guidelines on Bone Metabolism and Disease in CKD, which are expected to be released in 2003. A preliminary draft was presented at the American Society of Nephrology meeting held in Philadelphia in 2002. A K/DOQI target range of 150 to 300 pg/mL for PTH was proposed.

These recommendations reflect the growing concern of experts in this field that there is a need to impose tighter controls on the concentrations of PTH, Ca, P, and Ca´P that should be permitted in ESRD patients. The K/DOQI recommendation on target range for PTH levels is expected to be between 150 and 300 pg/mL.

Goals in the treatment of secondary HPT include (1) achieving appropriate PTH concentrations without a concomitant increase in calcium concentrations; (2) normalization of hyperphosphatemia; and (3) maintenance of normal skeletal function. (Goodman 2001/1188; Cunningham 1999/S-60) In effect, the goal is to achieve and maintain a state of normal bone and mineral metabolism. The ultimate goal is to decrease morbidity and mortality in these patients.

Goals in the treatment of secondary HPT include (1) achieving appropriate PTH concentrations without a concomitant increase in calcium concentrations; (2) normalization of hyperphosphatemia; and (3) maintenance of normal skeletal function. (Goodman 2001/1188; Cunningham 1999/S-60) In effect, the goal is to achieve and maintain a state of normal bone and mineral metabolism. The ultimate goal is to decrease morbidity and mortality in these patients.

Ibis technology marries two technologies,.  Unlike traditional culture testing, Ibis testing does not require that test samples retain viability and is not limited by selection for proper media and culture conditions.  Thus one can perform an accurate and unbiased "microbial census" in a single assay.  We intend to run two determinations on trial specimens.    The Ibis Sterile Fluids Viral Assay will be used to identify the population of RNA and DNA viruses present in serum specimens and the Ibis Sterile Fluids Bacterial Assay will be used to identify the population of bacteria present in whole blood specimens.  The viral assay has been optimized to include the following families of viruses:  adenovirus, herpesvirus, parvovirus, flavivirus, picornavirus, and alphavirus.  The bacterial assay has been optimized to detect and identify virtually any species of bacteria known to cause serious disease in humans. 

Serum and whole blood samples will be collected during Treatment Day 1 and Treatment Week 28/Early Termination, to identify and detect bacterial and viral species known to cause infections in humans.  Ibis test based on PCR and mass spectometery technology is currently an investigational research tool. The clinical implications and interpretations of results provided by Ibis test are not established yet.