Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3/4 Chronic Kidney Disease (CKD) With Secondary Hyperparathyroidism (SHPT)

Completed · Phase 4

Conditions studied: Secondary Hyperparathyroidism, Chronic Kidney Disease

In brief

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.

Key facts

Study ID

NCT00823303

Run by

Washington University School of Medicine

People needed

110

Starts

2009-02-01

Expected to finish

2013-09-01

Last updated by the study team

2014-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 < 10.0 mg/dL at baseline
• Phosphorus < 4.6 mg/dL at baseline
• If on a phosphorus binder; no change in dose within the 4 weeks prior to screening

You may not qualify if…

• Receiving any active form of vitamin D within 4 weeks prior to screening (calcitriol, doxercalciferol; paricalcitol; alfacalcidol)
• Receiving >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

Where it is running

• Northwestern University — Chicago, Illinois, United States
• Northshore University Health System — Evanston, Illinois, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Washington University — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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