Trial to Optimize Mineral Outcomes in Dialysis Patients

Phase 4

Completed

• Conditions: Secondary Hyperparathyroidism; Chronic Kidney Disease
• Interventions: Other: Cinacalcet, active vitamin D analogue

• Registration Number: NCT01100723
• Lead Sponsor: University of Colorado, Denver

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

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-04-07
• Study First Submitted QC: 2010-04-08
• Study First Posted: 2010-04-09
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Results First Submitted: 2013-01-23
• Status Verified: 2016-11
• Results First Submitted QC: 2016-11-04
• Last Update Submitted: 2016-11-04
• Results First Posted: 2017-01-02
• Last Update Posted: 2017-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Computer directed dosing decisions	Cinacalcet, active vitamin D analogue	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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.

Trial Locations

Locations (1)

Lynchburg Nephrology Associates, P.L.L.C.; 🇺🇸 Lynchburg, Virginia, United States