Trial to Optimize Mineral Outcomes in Dialysis Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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 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). 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 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. 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. 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. 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. Compare the mean and standard deviation (SD) at baseline and 6 and 12 months for PTH, calcium and phosphorus. 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 per month of paricalcitol) after the application of a computerized dosing protocol for management of CKD-MBD. 1 mcg paricalcitol = 0.5 mcg doxercalciferol 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. 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

Official Title
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Trial to Optimize Mineral Outcomes in End Stage Renal Disease (ESRD) Patients

Conditions
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Secondary Hyperparathyroidism, Chronic Kidney Disease

Intervention / Treatment
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* Other: Cinacalcet, active vitamin D analogue


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women 18 years of age or older On outpatient hemodialysis Have a level of understanding and willingness to cooperate with the study personnel Able to provide informed consent Exclusion Criteria: Currently enrolled in another interventional clinical trial Are pregnant, plan on becoming pregnant during the study period, or breast-feeding Planned parathyroidectomy within 6 months Planned kidney transplant within 6 months Life expectancy < 6 months Patient declines participation Liver function tests > 2 times the upper limit of normal

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Computer directed dosing decisions<br>This study will be an open-label, non-randomized, single arm design. Patients will have their mineral and bone disorders managed by the computer directed algorithm. The computer algorithm will make recommendations for dosing active vitamin D and cinacalcet. The doses of these medications recommended by the algorithm will then be prescribed to the subjects participating in the study unless overridden by the patients primary attending nephrology for other clinical or safety concerns. At any time in the study, subjects may be on neither, one, or both of these medication depending on their laboratory results and the output recommendations of the algorithm. | Other: Cinacalcet, active vitamin D analogue<br>* Patients will have their mineral and bone disorders managed by the computer directed algorithm. Cinacalcet will be dose increased starting at 30 mg/day as indicated by protocol along with active vitamin D based on values of serum calcium, phosphorus and parathyroid hormone.<br>* Other names: sensipar, paricalcitol, doxercalciferol, calcitriol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Patients Achieving Parathyroid Hormone Target ≤ 300 | 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 disease-mineral and bone disorder (CKD-MBD). If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range. | 1 year | 
| Percent of Patients Achieving Phosphorous Target ≤ 5.5 | 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. If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Patients Achieving Parathyroid Hormone Target ≤ 450 | 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. If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range. | 1 year | 
| Percent of Patients Achieving Phosphorous Target ≤ 4.5 | 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. If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range. | 1 year | 
| Percent of Patients Achieving Calcium Target ≤ 10.1 | 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. If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range. | 1 year | 
| Percent of Patients on Cinacalcet and Vitamin D Analogues | 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. If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range. | 6 months and 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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secondary hyperparathyroidism, calcium, phosphorus, ESRD, CKD, mineral disorder