Trial to Optimize Mineral Outcomes in Dialysis Patients

NCT01100723 | Completed Phase 4 Results

• 1 other identifier: 09-0623
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Secondary Hyperparathyroidism; Chronic Kidney Disease

Keywords

secondary hyperparathyroidism; calcium; phosphorus; ESRD; CKD; mineral disorder

Outcome Measures

Primary Outcomes (2)

• Percent of Patients Achieving Parathyroid Hormone Target ≤ 300

  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.

  1 year

• Percent of Patients Achieving Phosphorous Target ≤ 5.5

  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.

  1 year

Secondary Outcomes (4)

• Percent of Patients Achieving Parathyroid Hormone Target ≤ 450

  1 year

• Percent of Patients Achieving Phosphorous Target ≤ 4.5

  1 year

• Percent of Patients Achieving Calcium Target ≤ 10.1

  1 year

• Percent of Patients on Cinacalcet and Vitamin D Analogues

  6 months and 1 year

Study Arms (1)

Computer directed dosing decisions

EXPERIMENTAL

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

Interventions

Cinacalcet, active vitamin D analogue 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.

Also known as: sensipar, paricalcitol, doxercalciferol, calcitriol

Computer directed dosing decisions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

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

Lynchburg, Virginia, 24501, United States

Location

Related 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.

  PMID: 22300740 BACKGROUND

MeSH Terms

Conditions

Hyperparathyroidism, Secondary; Renal Insufficiency, Chronic; Kidney Failure, Chronic

Interventions

Cinacalcet; paricalcitol; 1 alpha-hydroxyergocalciferol; Calcitriol

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Limitations and Caveats

No adverse events reported. Dose titration limited by hypocalcemia and subject non-adherent to oral medications.

Results Point of Contact

• Title: Dr. David M. Spiegel
• Organization: University of Colorado

david.spiegel@ucdenver.edu

303-724-7797

Study Officials

• David M Spiegel, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2010
• First Posted: April 9, 2010
• Study Start: March 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: January 2, 2017
• Results First Posted: January 2, 2017

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)