Phase 4
N=110
Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3/4 Chronic Kidney Disease (CKD) With Secondary Hyperparathyroidism (SHPT)
Secondary Hyperparathyroidism · Chronic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT00823303 ↗Enrolled (actual)
110
Serious AEs
0.9%
Results posted
Aug 2014
Primary outcome: Primary: Confirmed Hypercalcemia — 3; 1 participants — p=0.36
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Paricalcitol (Drug); Calcitriol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Confirmed Hypercalcemia |
3; 1 | 0.36 |
Summary
Secondary Hyperparathyroidism (SHPT) occurs in many patients with kidney disease and leads to bone disease. Active forms of vitamin D, calcitriol and paricalcitol, treat SHPT, but may have different effects on blood calcium. This study will randomize patients with SHPT and stage 3 or 4 CKD to treatment with calcitriol or paricalcitol, and monitor patients for the incidence of high blood calcium, and effectiveness of SHPT treatment.
Eligibility Criteria
Inclusion Criteria
- Age >18; Able to give informed consent
- Chronic kidney disease, and estimated GFR 15 to 60 ml/min using the abbreviated MDRD equation
- intact PTH (iPTH) >120 pg/ml at baseline
- albumin corrected calcium > 8.5 mg/dL to 50,000 IU per month of ergocalciferol or > 1000 IU of cholecalciferol per day within the previous 30 days.
- history of primary HPT
- On prednisone > 30 days within the previous 6 months
- receiving bisphosphonates or calcitonin within the previous 12 months
- Non-elective hospitalization within the previous 30 days.
- Expected to initiate dialysis or receive a kidney transplant within the next 6 mo.
- History of renal or other organ transplant
- History of parathyroidectomy or previous diagnosis of primary hyperparathyroidism
- Receiving cinacalcet within 4 weeks prior to screening.
- An active drug/alcohol dependence or abuse history
- History of non-compliance with visits or medications that preclude study compliance in the opinion of the investigator
- Pregnant, or able to become pregnant and unwilling to use a birth control method considered reliable by the principal investigator
Data sourced from ClinicalTrials.gov (NCT00823303). 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.