- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00958451
Vitamin D Deficiency in Chronic Kidney Disease (CKD) Patients
March 23, 2011 updated by: Salem Veterans Affairs Medical Center
Response of Secondary Hyperparathyroidism to Paricalcitol Versus Ergocalciferol in Patients With Stage 3 and 4 Chronic Kidney Disease With Vitamin D Deficiency: a Randomized Controlled Trial
This is an open label, single center, randomized, active comparator controlled study, comparing the effects of vitamin D replacement using oral ergocalciferol versus paricalcitol on parathyroid hormone (PTH) levels in patients with stage 3 and 4 CKD and vitamin D deficiency or insufficiency.
The purpose of this study is to determine which of these two approaches is more successful.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
This study will enroll chronic kidney disease patients, stage 3 and 4, who have low serum vitamin D levels as defined by K DOQI Guidelines.
Patients will be randomized to receive oral daily ergocalciferol or paricalcitol.
A total of 80 patients will be enrolled, 40 in the cholecalciferol group and 40 in the paricalcitol group.
Outcomes will be assessed as proportion of patients achieving pre-defined changes from baseline and as absolute changes from baseline values.
Baseline values will be determined from averaging two consecutive measurements of the variables of interest prior to randomization.
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Virginia
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Salem, Virginia, United States, 24153
- VA Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female chronic kidney disease patients at least 18 years of age.
- Patients should be able and willing to provide written informed consent and HIPAA Authorization.
- Chronic kidney disease stage 3 or 4.
- Plasma intactPTH level above 75pg/ml.
- Serum 25 OHD level below 30ng/ml.
- Negative pregnancy test unless 2 years postmenopausal or with a documented tubal ligation or total hysterectomy.
- Patients need to be off of any Vitamin analogues or preparations for 4 weeks prior to screening.
Exclusion Criteria:
- Women who are breast feeding, pregnant, capable of becoming pregnant, and not participating in an acceptable form of birth control.
- Patients currently participating in a clinical trial with another investigational drug or device or who have receive an investigational drug or device within 30 days of enrollment in this study.
- Major surgery within one month prior to enrollment or planned surgery while patient is in study (other than dialysis vascular access surgery).
- Patients who have had a malignancy unless they have received curative treatment and have been disease free for 2 years.
- Patients with a medical status that the PI decides would preclude participation.
- Patients on hemodialysis or peritoneal dialysis.
- Patients with a functional renal transplant.
- Patients with allergies to study drugs.
- Patients with acute renal failure with the past 12 weeks.
- Patients with clinically significant gastrointestinal or liver disease.
- Patients with active granulomatous disease.
- Patients with urine calcium:creatinine ratio of more than 0.2.
- Patients who received vitamin D analogs, calcimimetics, or biphosphonates within 4 weeks before screening. Treatment with any one of these medicines during the study is not permitted.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Paricalcitol
Arm 1: 40 patients will be assigned to paricalcitol treatment group.
Patients will be randomized once they meet inclusion and exclusion criteria.
If patients are not on any vitamin D treatment when enrolled, they will have 2 screening visits before randomization.
Screening visits will consist of a physical exam and lab tests to measure Vitamin D, calcium, iPTH, and safety profile.
Patients on vitamin D treatment prior to study will have a minimum 4 week washout period before screening tests.
Patients' Lean Body Mass and Aortic Blood Pressure and pulse wave velocity will be measured before dosing.
Cardiovascular markers will be checked throughout the study.
Patients will be monitored monthly after starting study treatment.
Total treatment period: 4 months.
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Active Comparator: Ergocalciferol
Arm 2: 40 patients will be assigned to the Ergocalciferol treatment group.
Patients will be randomized once they meet inclusion and exclusion criteria.
If patients are not on any vitamin D treatment when enrolled, they will have 2 screening visits before randomization.
Screening visits will consist of a physical exam and lab tests to measure Vitamin D, calcium, iPTH, and safety profile.
Patients on vitamin D treatment prior to study will have a minimum 4 week washout period before screening tests.
Patients' Lean Body Mass and Aortic Blood Pressure and pulse wave velocity will be measured before dosing.
Cardiovascular markers will be checked throughout the study.
Patients will be monitored monthly after starting study treatment.
Total treatment period: 4 months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To achieve 2 consecutive iPTH measurements with 30% or greater decrease from baseline
Time Frame: 2 years
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2 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To achieve 25OHD level above 30 ng/ml and change cardiovascular markers
Time Frame: 2 years
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2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Csaba P. Kovesdy, M.D., Salem VAMC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Actual)
January 1, 2011
Study Completion (Actual)
January 1, 2011
Study Registration Dates
First Submitted
August 11, 2009
First Submitted That Met QC Criteria
August 12, 2009
First Posted (Estimate)
August 13, 2009
Study Record Updates
Last Update Posted (Estimate)
March 24, 2011
Last Update Submitted That Met QC Criteria
March 23, 2011
Last Verified
August 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms
- Urologic Diseases
- Endocrine System Diseases
- Renal Insufficiency
- Nutrition Disorders
- Parathyroid Diseases
- Neoplastic Processes
- Avitaminosis
- Deficiency Diseases
- Malnutrition
- Kidney Diseases
- Renal Insufficiency, Chronic
- Hyperparathyroidism
- Neoplasm Metastasis
- Vitamin D Deficiency
- Hyperparathyroidism, Secondary
- Physiological Effects of Drugs
- Micronutrients
- Vitamins
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vitamin D
- Ergocalciferols
Other Study ID Numbers
- CK0023
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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