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Trial to Optimize Mineral Outcomes in Dialysis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01100723
First received: April 7, 2010
Last updated: December 3, 2012
Last verified: October 2012
History of Changes
  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
 Drug: cinacalcet and/or active vitamin D analogue
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Trial to Optimize Mineral Outcomes in End Stage Renal Disease (ESRD) Patients

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Parathyroid hormone [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.

  • Phosphorus [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Parathyroid hormone [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.

  • Phosphorus [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.

  • Calcium [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.

  • Medication Use [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


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: Dosing by computer algorithm
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.
 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.

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 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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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, 090623
Study First Received: April 7, 2010
Last Updated: December 3, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Parathyroid Diseases
Endocrine System Diseases
Urologic Diseases
 Renal Insufficiency
Vitamin D
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 23, 2013