Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00823303
Recruitment Status : Completed
First Posted : January 15, 2009
Results First Posted : August 5, 2014
Last Update Posted : August 7, 2014
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

Tracking Information
First Submitted Date  ICMJE December 12, 2008
First Posted Date  ICMJE January 15, 2009
Results First Submitted Date  ICMJE June 5, 2014
Results First Posted Date  ICMJE August 5, 2014
Last Update Posted Date August 7, 2014
Study Start Date  ICMJE February 2009
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2014)
Confirmed Hypercalcemia [ Time Frame: 24 week treatment period ]
Serum Calcium 10.5 mg/dL or higher, confirmed by repeat measurement.
Original Primary Outcome Measures  ICMJE
 (submitted: January 14, 2009)
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 ]
Change History Complete list of historical versions of study NCT00823303 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2009)
  • difference between treatment groups in change in serum calcium [ Time Frame: 6 months ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3/4 Chronic Kidney Disease (CKD) With Secondary Hyperparathyroidism (SHPT)
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Secondary Hyperparathyroidism
  • Chronic Kidney Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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 Sep 5;9(9):1620-6. doi: 10.2215/CJN.10661013. Epub 2014 Jun 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 14, 2009)
110
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00823303
Other Study ID Numbers  ICMJE 22095
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daniel W. Coyne, Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE
  • Henry Ford Hospital
  • Feinberg School of Medicine, Northwestern University
  • NorthShore University HealthSystem
  • Abbott
Investigators  ICMJE
Principal Investigator: Daniel W Coyne, MD Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date August 2014

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