Phase 4
N=92
Trial to Optimize Mineral Outcomes in Dialysis Patients
Secondary Hyperparathyroidism · Chronic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT01100723 ↗Enrolled (actual)
92
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: Percent of Patients Achieving Parathyroid Hormone Target ≤ 300 — 21 percentage of subjects meeting target — p=< 0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Cinacalcet, active vitamin D analogue (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Patients Achieving Parathyroid Hormone Target ≤ 300 |
21 | < 0.05 sig |
| PRIMARY Percent of Patients Achieving Phosphorous Target ≤ 5.5 |
53 | <0.05 sig |
| SECONDARY Percent of Patients Achieving Parathyroid Hormone Target ≤ 450 |
33 | < 0.05 sig |
| SECONDARY Percent of Patients Achieving Phosphorous Target ≤ 4.5 |
29 | < 0.05 sig |
| SECONDARY Percent of Patients Achieving Calcium Target ≤ 10.1 |
78 | < 0.05 sig |
| SECONDARY Percent of Patients on Cinacalcet and Vitamin D Analogues |
84 | < 0.05 sig |
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.
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 2 times the upper limit of normal
Data sourced from ClinicalTrials.gov (NCT01100723). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.