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Trial to Optimize Mineral Outcomes in Dialysis Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01100723
First Posted: April 9, 2010
Last Update Posted: January 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Colorado, Denver
  Purpose
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.

Condition Intervention Phase
Secondary Hyperparathyroidism Chronic Kidney Disease Other: Cinacalcet, active vitamin D analogue Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Trial to Optimize Mineral Outcomes in End Stage Renal Disease (ESRD) Patients

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Percent of Patients Achieving Parathyroid Hormone Target ≤ 300 [ Time Frame: 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 [ Time Frame: 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:
  • Percent of Patients Achieving Parathyroid Hormone Target ≤ 450 [ Time Frame: 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 Phosphorous Target ≤ 4.5 [ Time Frame: 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 Calcium Target ≤ 10.1 [ Time Frame: 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 [ Time Frame: 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.


Enrollment: 92
Study Start Date: March 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Other: 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.
Other Name: sensipar, paricalcitol, doxercalciferol, calcitriol

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01100723


Locations
United States, Virginia
Lynchburg Nephrology Associates, P.L.L.C.
Lynchburg, Virginia, United States, 24501
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: David M Spiegel, MD University of Colorado, Denver
  More Information

Publications:
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01100723     History of Changes
Other Study ID Numbers: 09-0623
First Submitted: April 7, 2010
First Posted: April 9, 2010
Results First Submitted: January 23, 2013
Results First Posted: January 2, 2017
Last Update Posted: January 2, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Colorado, Denver:
secondary hyperparathyroidism
calcium
phosphorus
ESRD
CKD
mineral disorder

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Hyperparathyroidism
Hyperparathyroidism, Secondary
Urologic Diseases
Renal Insufficiency
Parathyroid Diseases
Endocrine System Diseases
Vitamins
Vitamin D
Ergocalciferols
Cinacalcet Hydrochloride
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists