Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3/4 Chronic Kidney Disease (CKD) With Secondary Hyperparathyroidism (SHPT) (PACE)
This study is ongoing, but not recruiting participants.
Sponsor:
Washington University School of Medicine
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
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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
- 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
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 School of Medicine |
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 June 18, 2013