Chronic Kidney Disease Clinical Trial
Official title:
Trial to Optimize Mineral Outcomes in End Stage Renal Disease (ESRD) Patients
This trial is designed to determine if the use of a computer algorithm designed to optimize mineral outcomes in dialysis patients increases the number of patients achieving the desired target endpoints for calcium, phosphorus and parathyroid hormone.
It is our hypothesis that a computerized dosing protocol incorporating both cinacalcet and
vitamin D analogues can achieve significantly better control of mineral and bone parameters
than currently observed in most dialysis facilities. This trial will test this hypothesis.
Objectives Primary Objectives
1. Compare the percent of patients achieving an intact parathyroid hormone (PTH) target of
≤ 300 pg/ml before and after the application of a computerized dosing protocol for
management of chronic kidney diseases mineral and bone disorder (CKD-MBD).
2. Compare the percent of patients achieving a phosphorus of ≤ 5.5 mg/dL before and after
the application of a computerized dosing protocol for management of CKD-MBD.
Secondary Objectives
1. Compare the percent of patients achieving an intact PTH target of ≤ 450 pg/ml before
and after the application of a computerized dosing protocol for management of CKD-MBD.
2. Compare the percent of patients achieving a phosphorus of ≤ 4.5 mg/dL before and after
the application of a computerized dosing protocol for management of CKD-MBD.
3. Compare the percent of patients achieving a calcium ≤ 10.1 mg/dL before and after the
application of a computerized dosing protocol for management of CKD-MBD.
4. Compare the percent of patients on cinacalcet and vitamin D analogues at baseline and
at 6 and 12 months after the application of a computerized dosing protocol for
management of CKD-MBD.
5. Compare the mean and standard deviation (SD) at baseline and 6 and 12 months for PTH,
calcium and phosphorus.
6. Compare the total monthly and average weekly (for patients on the medication) active
vitamin D analogue dose at baseline and at 6 and 12 months (converted to mcg q month of
paricalcitol) after the application of a computerized dosing protocol for management of
CKD-MBD. 1 mcg paricalcitol = 0.5 mcg doxercalciferol
7. Compare the number of patients on calcium and non-calcium binders at baseline and at 6
and 12 months after the application of a computerized dosing protocol for management of
CKD-MBD.
8. Determine the percent of patients who are non-compliant with oral cinacalcet and the
percent that are unable to tolerate the dose required by the algorithm to achieve
target outcomes
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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