Trial to Optimize Mineral Outcomes in Dialysis Patients

Last updated: November 4, 2016
Sponsor: University of Colorado, Denver
Overall Status: Completed

Phase

4

Condition

Hyperparathyroidism

Parathyroid Disorders

Nephropathy

Treatment

N/A

Clinical Study ID

NCT01100723
09-0623
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 92
Study Start date:
March 01, 2010
Estimated Completion Date:
August 31, 2011

Study 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

Connect with a study center

  • Lynchburg Nephrology Associates, P.L.L.C.

    Lynchburg, Virginia 24501
    United States

    Site Not Available

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