Phase
Condition
Parathyroid Disease
Nephropathy
Parathyroid Disorders
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 HIPAAAuthorization.
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 tuballigation or total hysterectomy.
Patients need to be off of any Vitamin analogues or preparations for 4 weeks prior toscreening.
Exclusion
Exclusion Criteria:
Women who are breast feeding, pregnant, capable of becoming pregnant, and notparticipating in an acceptable form of birth control.
Patients currently participating in a clinical trial with another investigational drugor device or who have receive an investigational drug or device within 30 days ofenrollment in this study.
Major surgery within one month prior to enrollment or planned surgery while patient isin study (other than dialysis vascular access surgery).
Patients who have had a malignancy unless they have received curative treatment andhave 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 4weeks before screening. Treatment with any one of these medicines during the study isnot permitted.
Study Design
Study Description
Connect with a study center
VA Medical Center
Salem, Virginia 24153
United StatesSite Not Available
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