Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3/4 Chronic Kidney Disease (CKD) With Secondary Hyperparathyroidism (SHPT) (PACE)
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| ClinicalTrials.gov Identifier: NCT00823303 |
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Recruitment Status :
Completed
First Posted : January 15, 2009
Results First Posted : August 5, 2014
Last Update Posted : August 7, 2014
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Sponsor:
Washington University School of Medicine
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
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Secondary Hyperparathyroidism Chronic Kidney Disease | Drug: Paricalcitol Drug: Calcitriol | Phase 4 |
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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 110 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 |
| Study Start Date : | February 2009 |
| Actual Primary Completion Date : | May 2013 |
| Actual Study Completion Date : | September 2013 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Kidney Diseases
| Arm | Intervention/treatment |
|---|---|
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Experimental: Paricalcitol
titrated to achieve 40-60% PTH suppression
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Drug: Paricalcitol
1 mcg daily, adjusted to achieve 40-60% PTH suppression
Other Name: Zemplar |
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Active Comparator: Calcitriol
titrated to achieve 40-60% PTH suppression
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Drug: Calcitriol
0.25 mcg daily, adjusted to achieve 40-60% PTH suppression
Other Name: Rocaltrol |
Primary Outcome Measures :
- Confirmed Hypercalcemia [ Time Frame: 24 week treatment period ]Serum Calcium 10.5 mg/dL or higher, confirmed by repeat measurement.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00823303
Locations
| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| 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
Henry Ford Hospital
Feinberg School of Medicine, Northwestern University
NorthShore University HealthSystem
Abbott
Investigators
| Principal Investigator: | Daniel W Coyne, MD | Washington University School of Medicine |
Publications of Results:
| Responsible Party: | Daniel W. Coyne, Professor of Medicine, Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00823303 |
| Other Study ID Numbers: |
22095 |
| First Posted: | January 15, 2009 Key Record Dates |
| Results First Posted: | August 5, 2014 |
| Last Update Posted: | August 7, 2014 |
| Last Verified: | August 2014 |
Keywords provided by Daniel W. Coyne, Washington University School of Medicine:
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PTH Active Vitamin D hypercalcemia Chronic Kidney Disease |
Additional relevant MeSH terms:
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Neoplasm Metastasis Kidney Diseases Renal Insufficiency, Chronic Hyperparathyroidism Hyperparathyroidism, Secondary Urologic Diseases Neoplastic Processes Neoplasms Pathologic Processes Renal Insufficiency Parathyroid Diseases Endocrine System Diseases |
Calcitriol Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Calcium Channel Agonists Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Vasoconstrictor Agents Vitamins Micronutrients Nutrients Growth Substances Bone Density Conservation Agents |