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

Study Overview
=================
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 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.

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 study duration is 26 weeks (1 week screening, 24 weeks active medications, 1 week follow up. Patients meeting inclusion/exclusion criteria including baseline laboratory results will be randomized to paricalcitol or calcitriol, and enter a 24 weeks treatment phase. Visits, including safety and efficacy laboratory tests will be at weeks 4, 8, 12, 18, and 24. A follow up visit will be performed 1 week after stopping study medication.

Official Title
-----------------
A Phase 4 Randomized Multicenter Open Label Trial of Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3 or 4 Ckd Patients With Secondary Hyperparathyroidism

Conditions
-----------------
Secondary Hyperparathyroidism, Chronic Kidney Disease

Intervention / Treatment
-----------------
* Drug: Paricalcitol
* Drug: Calcitriol


Participation Criteria
=================
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 < 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paricalcitol<br>titrated to achieve 40-60% PTH suppression | Drug: Paricalcitol<br>* 1 mcg daily, adjusted to achieve 40-60% PTH suppression<br>* Other names: Zemplar;|
| Active Comparator: Calcitriol<br>titrated to achieve 40-60% PTH suppression | Drug: Calcitriol<br>* 0.25 mcg daily, adjusted to achieve 40-60% PTH suppression<br>* Other names: Rocaltrol;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirmed Hypercalcemia | Serum Calcium 10.5 mg/dL or higher, confirmed by repeat measurement. | 24 week treatment period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PTH, Active Vitamin D, hypercalcemia, Chronic Kidney Disease