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

This study has been completed.
Sponsor:
Collaborators:
Henry Ford Hospital
Feinberg School of Medicine, Northwestern University
NorthShore University HealthSystem
Abbott
Information provided by (Responsible Party):
Daniel W. Coyne, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00823303
First received: December 12, 2008
Last updated: August 4, 2014
Last verified: August 2014

December 12, 2008
August 4, 2014
February 2009
May 2013   (final data collection date for primary outcome measure)
Confirmed Hypercalcemia [ Time Frame: 24 week treatment period ] [ Designated as safety issue: Yes ]
Serum Calcium 10.5 mg/dL or higher, confirmed by repeat measurement.
The primary objective is to determine the percentage of patients developing confirmed hypercalcemia during 6 months of daily treatment for SHPT. This is a safety endpoint. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00823303 on ClinicalTrials.gov Archive Site
Not Provided
  • difference between treatment groups in change in serum calcium [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • difference between treatment groups in change in urinary calcium, incidence of hyperphosphatemia, change in serum phosphorus, change in Alkaline Phosphatase, percentage of patients achieving > 40% PTH suppression, and mean PTH suppression. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3/4 Chronic Kidney Disease (CKD) With Secondary Hyperparathyroidism (SHPT)
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

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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Secondary Hyperparathyroidism
  • Chronic Kidney Disease
  • Drug: Paricalcitol
    1 mcg daily, adjusted to achieve 40-60% PTH suppression
    Other Name: Zemplar
  • Drug: Calcitriol
    0.25 mcg daily, adjusted to achieve 40-60% PTH suppression
    Other Name: Rocaltrol
  • Experimental: Paricalcitol
    titrated to achieve 40-60% PTH suppression
    Intervention: Drug: Paricalcitol
  • Active Comparator: Calcitriol
    titrated to achieve 40-60% PTH suppression
    Intervention: Drug: Calcitriol
Coyne DW, Goldberg S, Faber M, Ghossein C, Sprague SM. A Randomized Multicenter Trial of Paricalcitol versus Calcitriol for Secondary Hyperparathyroidism in Stages 3-4 CKD. Clin J Am Soc Nephrol. 2014 Jun 26. pii: CJN.10661013. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
September 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria

  1. Age >18; Able to give informed consent
  2. Chronic kidney disease, and estimated GFR 15 to 60 ml/min using the abbreviated MDRD equation
  3. intact PTH (iPTH) >120 pg/ml at baseline
  4. albumin corrected calcium > 8.5 mg/dL to < 10.0 mg/dL at baseline
  5. Phosphorus < 4.6 mg/dL at baseline
  6. If on a phosphorus binder; no change in dose within the 4 weeks prior to screening

Exclusion Criteria

  1. Receiving any active form of vitamin D within 4 weeks prior to screening (calcitriol, doxercalciferol; paricalcitol; alfacalcidol)
  2. Receiving >50,000 IU per month of ergocalciferol or > 1000 IU of cholecalciferol per day within the previous 30 days.
  3. history of primary HPT
  4. On prednisone > 30 days within the previous 6 months
  5. receiving bisphosphonates or calcitonin within the previous 12 months
  6. Non-elective hospitalization within the previous 30 days.
  7. Expected to initiate dialysis or receive a kidney transplant within the next 6 mo.
  8. History of renal or other organ transplant
  9. History of parathyroidectomy or previous diagnosis of primary hyperparathyroidism
  10. Receiving cinacalcet within 4 weeks prior to screening.
  11. An active drug/alcohol dependence or abuse history
  12. History of non-compliance with visits or medications that preclude study compliance in the opinion of the investigator
  13. Pregnant, or able to become pregnant and unwilling to use a birth control method considered reliable by the principal investigator
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00823303
22095
Yes
Daniel W. Coyne, Washington University School of Medicine
Washington University School of Medicine
  • Henry Ford Hospital
  • Feinberg School of Medicine, Northwestern University
  • NorthShore University HealthSystem
  • Abbott
Principal Investigator: Daniel W Coyne, MD Washington University Early Recognition Center
Washington University School of Medicine
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP