Status:
COMPLETED
Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3/4 Chronic Kidney Disease (CKD) With Secondary Hyperparathyroidism (SHPT)
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Henry Ford Hospital
Northwestern University Feinberg School of Medicine
Conditions:
Secondary Hyperparathyroidism
Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 e...
Detailed Description
General Design * Open label, active comparator, multicenter, parallel group, phase 4 study of paricalcitol versus calcitriol for suppression of PTH in stage 3 and 4 CKD patients with SHPT. * Total st...
Eligibility Criteria
Inclusion
- 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 \< 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
- Exclusion Criteria
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00823303
Start Date
February 1 2009
End Date
September 1 2013
Last Update
August 7 2014
Active Locations (4)
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1
Northwestern University
Chicago, Illinois, United States, 60611
2
Northshore University Health System
Evanston, Illinois, United States, 60201
3
Henry Ford Hospital
Detroit, Michigan, United States, 48202
4
Washington University
St Louis, Missouri, United States, 63110