Trial to Optimize Mineral Outcomes in End Stage Renal Disease (ESRD) Patients
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 92
- Locations
- 2
- Primary Endpoint
- Percent of Patients Achieving Parathyroid Hormone Target ≤ 300
Study Overview
Brief Summary
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
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Percent of Patients Achieving Parathyroid Hormone Target ≤ 300
Time Frame: 1 year
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.
Percent of Patients Achieving Phosphorous Target ≤ 5.5
Time Frame: 1 year
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.
Secondary Outcomes
- Percent of Patients Achieving Phosphorous Target ≤ 4.5(1 year)
- Percent of Patients Achieving Parathyroid Hormone Target ≤ 450(1 year)
- Percent of Patients Achieving Calcium Target ≤ 10.1(1 year)
- Percent of Patients on Cinacalcet and Vitamin D Analogues(6 months and 1 year)