Status:
COMPLETED
Vitamin D Deficiency in Chronic Kidney Disease (CKD) Patients
Lead Sponsor:
Salem Veterans Affairs Medical Center
Collaborating Sponsors:
Abbott
Conditions:
Secondary Hyperparathyroidism
Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 hormon...
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 ergocalcif...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2011
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00958451
Start Date
July 1 2009
End Date
January 1 2011
Last Update
March 24 2011
Active Locations (1)
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1
VA Medical Center
Salem, Virginia, United States, 24153