Clinical trial NCT01100723: Trial to Optimize Mineral Outcomes in Dialysis Patients
Official title: Trial to Optimize Mineral Outcomes in End Stage Renal Disease (ESRD) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Secondary Hyperparathyroidism
Chronic Kidney Disease
Keywords: secondary hyperparathyroidism
calcium
phosphorus
ESRD
CKD
mineral disorder
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2010-04-09
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Percent of Patients Achieving Parathyroid Hormone Target ≤ 300
timeFrame: 1 year
measure: Percent of Patients Achieving Phosphorous Target ≤ 5.5
timeFrame: 1 year
Secondary outcomes:
measure: Percent of Patients Achieving Parathyroid Hormone Target ≤ 450
timeFrame: 1 year
measure: Percent of Patients Achieving Phosphorous Target ≤ 4.5
timeFrame: 1 year
measure: Percent of Patients Achieving Calcium Target ≤ 10.1
timeFrame: 1 year
measure: Percent of Patients on Cinacalcet and Vitamin D Analogues
timeFrame: 6 months and 1 year
Other outcomes:
Locations:
city: Lynchburg
country: United States
facility: Lynchburg Nephrology Associates, P.L.L.C.
state: Virginia
Study officials:
affiliation: University of Colorado, Denver
name: David M Spiegel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spiegel DM, McPhatter L, Allison A, Drumheller JC, Lockridge R. A computerized treatment algorithm trial to optimize mineral metabolism in ESRD. Clin J Am Soc Nephrol. 2012 Apr;7(4):632-9. doi: 10.2215/CJN.08170811. Epub 2012 Feb 2.