Trial to Optimize Mineral Outcomes in Dialysis Patients

NCT ID: NCT01100723

Last Updated: 2017-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2011-08-31

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

Conditions

Secondary Hyperparathyroidism; Chronic Kidney Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Computer directed dosing decisions

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.

Group Type: EXPERIMENTAL

Cinacalcet, active vitamin D analogue

Intervention Type: OTHER

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.

Interventions

Cinacalcet, 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.

Intervention Type: OTHER

Other Intervention Names

sensipar, paricalcitol, doxercalciferol, calcitriol

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David M Spiegel, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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

Lynchburg, Virginia, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 22300740 (View on PubMed)

Other Identifiers

09-0623

Identifier Type: -

Identifier Source: org_study_id