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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Washington University School of Medicine.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
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: November 23, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Secondary Hyperparathyroidism
Chronic Kidney Disease
Drug: Paricalcitol
Drug: Calcitriol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 110
Study Start Date: February 2009
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paricalcitol
titrated to achieve 40-60% PTH suppression
Drug: Paricalcitol
1 mcg daily, adjusted to achieve 40-60% PTH suppression
Other Name: Zemplar
Active Comparator: Calcitriol
titrated to achieve 40-60% PTH suppression
Drug: Calcitriol
0.25 mcg daily, adjusted to achieve 40-60% PTH suppression
Other Name: Rocaltrol

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00823303

Locations
United States, Illinois
Northshore University Health System
Evanston, Illinois, United States, 60201
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Abbott
Investigators
Principal Investigator: Daniel W Coyne, MD Washington University
  More Information

No publications provided

Responsible Party: Daniel W. Coyne, Professor of Medicine, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00823303     History of Changes
Other Study ID Numbers: 22095
Study First Received: December 12, 2008
Last Updated: November 23, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
PTH
Active Vitamin D
hypercalcemia
Chronic Kidney Disease

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Parathyroid Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency
Calcitriol
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014