Chronic Kidney Disease, Secondary Hyperparathyroidism
Conditions
Keywords
secondary hyperparathyroidism, calcium, phosphorus, ESRD, CKD, mineral disorder
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 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 per 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
Interventions
OTHERCinacalcet, active vitamin D analogue
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.
Sponsors
University of Colorado, Denver
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Patients Achieving Parathyroid Hormone Target ≤ 300 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Percent of Patients Achieving Parathyroid Hormone Target ≤ 450 | 1 year | 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. |
| Percent of Patients Achieving Phosphorous Target ≤ 4.5 | 1 year | 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. |
| Percent of Patients Achieving Calcium Target ≤ 10.1 | 1 year | 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. |
| Percent of Patients on Cinacalcet and Vitamin D Analogues | 6 months and 1 year | 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. |
Countries
United States
Participant flow
Recruitment details
181 pts in dialysis center. 65 did not meet enrollment criteria. 23 declined participation and 1 had prior intolerance to cinacalcet. Therefore 92 subjects enrolled in study.
Pre-assignment details
No washout. Once enrolled, mineral and bone disorder managed by computer algorithm.
Participants by arm
| Arm | Count |
|---|---|
| Post Treatment Results analyzed at study evaluation time points. | 92 |
| Total | 92 |
Baseline characteristics
| Characteristic | Post Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 32 Participants |
| Age, Categorical Between 18 and 65 years | 60 Participants |
| Gender Female | 40 Participants |
| Gender Male | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 92 |
| serious Total, serious adverse events | 0 / 92 |
Outcome results
Primary
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.
Time frame: 1 year
Population: Subjects who had at least one laboratory measurement during the assessment phase.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Post Treatment | Percent of Patients Achieving Parathyroid Hormone Target ≤ 300 | 21 percentage of subjects meeting target |
Comparison: Number of subjects meeting targets were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects with PTH values in the target range was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.p-value: <0.05McNemar
Primary
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.
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Post Treatment | Percent of Patients Achieving Phosphorous Target ≤ 5.5 | 53 percent of participants in target |
Comparison: Number of subjects meeting targets were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects with phosphorus values in the target range was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.p-value: <0.05McNemar
Secondary
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.
Time frame: 1 year
Population: Subjects with at least one laboratory value during evaluation period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Post Treatment | Percent of Patients Achieving Calcium Target ≤ 10.1 | 78 percentage of subjects in target |
Comparison: Number of subjects meeting targets were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects with Ca values in the target range was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.p-value: <0.05McNemar
Secondary
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.
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Post Treatment | Percent of Patients Achieving Parathyroid Hormone Target ≤ 450 | 33 percent of participants in target |
Comparison: Number of subjects meeting targets were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects with PTH values in the target range was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.p-value: <0.05McNemar
Secondary
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.
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Post Treatment | Percent of Patients Achieving Phosphorous Target ≤ 4.5 | 29 percent of participants in target |
Comparison: Number of subjects meeting targets were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects with phosphorus values in the target range was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.p-value: <0.05McNemar
Secondary
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.
Time frame: 6 months and 1 year
Population: Number of subjects with at least 1 laboratory analysis during the evaluation period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Post Treatment | Percent of Patients on Cinacalcet and Vitamin D Analogues | 84 percentage of subjects receiving med |
Comparison: Proportion of subjects on specified medications were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects on the specified medications was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.p-value: <0.05McNemar