A Randomized, Prospective, Cross-Over Study of Calcitriol vs. Paricalcitol in the Treatment of Mineral and Bone Disease in Hemodialysis Patients

12027

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.

2012-11-01

2013-12-01

2015-10-01

Terminated

Early phase I

16

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 16, 'type': 'ACTUAL'}}

2023-11-07