Kidney Failure Clinical Trial
— ECRIPOfficial title:
A Randomized, Prospective, Cross-Over Study of Calcitriol vs. Paricalcitol in the Treatment of Mineral and Bone Disease in Hemodialysis Patients
NCT number | NCT01725113 |
Other study ID # | 12027 |
Secondary ID | |
Status | Terminated |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | November 2012 |
Est. completion date | October 2015 |
Verified date | October 2023 |
Source | Winthrop University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this non-inferiority study is to compare the safety and effectiveness of a mineral and bone disease treatment protocol based on calcitriol to one based on paricalcitol in hemodialysis patients using revised Kidney Disease: Improving Global Outcomes (KDIGO) parathyroid hormone targets.
Status | Terminated |
Enrollment | 16 |
Est. completion date | October 2015 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - All subjects will have been treated for at least three months on hemodialysis with IV paricalcitol. These subjects must have a most recent calcium level within the normal range, most recent phosphorus level < 8 mg/dL and a most recent PTH between 130-585 pg/mL Exclusion Criteria: Patients will be excluded if: 1. age greater than 18 2. active malignancy 3. expected survival greater than 6 months 4. high likelihood of renal transplant during the study period. 5. Low calcium bath 6. prior parathyroidectomy 7. use of calcimimetics |
Country | Name | City | State |
---|---|---|---|
United States | Winthrop University Hospital | Mineola | New York |
Lead Sponsor | Collaborator |
---|---|
Winthrop University Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Calcium Levels at Month 3 Post Calcitriol Treatment Initiation | Up to Month 6 | ||
Primary | Calcium Levels at Month 3 Post Paricalcitol Treatment Initiation | Up to Month 6 | ||
Secondary | PTH Levels at Month 3 Post Calcitriol Treatment Initiation | Up to Month 6 | ||
Secondary | PTH Levels at Month 3 Post Paricalcitol Treatment Initiation | Up to Month 6 | ||
Secondary | Phosphorus Levels at Month 3 Post Calcitriol Initiation | Up to Month 6 | ||
Secondary | Phosphorus Levels at Month 3 Post Paricalcitol Initiation | Up to Month 6 | ||
Secondary | Amount of Active Vitamin D Analog Used Through Month 3 Post Calcitriol Initiation | Up to Month 6 | ||
Secondary | Amount of Active Vitamin D Analog Used Through Month 3 Post Paricalcitol Initiation | Up to Month 6 |
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