Trial to Optimize Mineral Outcomes in Dialysis Patients

Chronic Kidney Disease Clinical Trial

Official title:

Trial to Optimize Mineral Outcomes in End Stage Renal Disease (ESRD) Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01100723
• Other study ID #: 09-0623
• Secondary ID: 090623
• Status: Completed
• Phase: Phase 4
• First received: April 7, 2010
• Last updated: December 3, 2012
• Start date: March 2010
• Est. completion date: August 2011

Study information

• Verified date: October 2012
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 q 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic
• Secondary Hyperparathyroidism

Intervention

Drug:
• cinacalcet and/or 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/d as indicated by protocol along with active vitamin D based on values of serum calcium, phosphorus and parathyroid hormone.

Locations

Country	Name	City	State
United States	Lynchburg Nephrology Associates, P.L.L.C.	Lynchburg	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parathyroid hormone	Compare the percent of patients achieving an intact PTH target of = 300 pg/ml before and after the application of a computerized dosing protocol for management of CKD-MBD.	1 year	No
Primary	Phosphorus	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.	1 year	No
Secondary	Parathyroid hormone	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.	1 year	No
Secondary	Phosphorus	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.	1 year	No
Secondary	Calcium	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.	1 year	No
Secondary	Medication Use	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.	1 year	No